Trial Outcomes & Findings for A Salvage Trial of AR Inhibition With ADT and Apalutamide With Radiation Therapy Followed by Docetaxel in Men With PSA Recurrent Prostate Cancer After Radical Prostatectomy (STARTAR) (NCT NCT03311555)
NCT ID: NCT03311555
Last Updated: 2024-03-19
Results Overview
The percentage of subjects with testosterone \>100 ng/dl at 36 months post-Cycle 1 Day 1 without one or more of the following: Serum PSA value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed (at least) 4 weeks later by a second PSA measurement higher than the first by any amount; Continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks; Evidence of clinical progression or initiation of systemic therapy for progressive disease; Death
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
up to 36 months
Results posted on
2024-03-19
Participant Flow
Participant milestones
| Measure |
Recurrent PSA-only Non-metastatic Prostate Cancer
Subjects with recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of greater than 0.2 ng/mL and less than 4 ng/mL in the absence of metastatic disease on CT and bone scans.
Apalutamide: 240mg tablet daily for 36 weeks
Androgen deprivation: ADT will consist of treatment with a GnRH agonist or antagonist per physician and institutional preference. Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix (Firmagon 120 mg or 240 mg SC) will be administered monthly, every 3 months, or every 6 months, depending on institutional standards, for 36 weeks total.
Salvage radiation therapy: On week 9 (+/- 28 days), subjects will begin salvage radiation therapy to the prostate bed. The total dose to the prostate bed must be 66-74 Gy in 1.8-2 Gy daily fractions over a total of 6-8 weeks
Docetaxel: About 4 weeks (+/- 2 weeks, pending recovery of adverse events from radiation to Grade 2 or less) after completing radiation, patients will start docetaxel 75mg/m2 intravenously, every 3 weeks for 6 cycles.
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Recurrent PSA-only Non-metastatic Prostate Cancer
Subjects with recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of greater than 0.2 ng/mL and less than 4 ng/mL in the absence of metastatic disease on CT and bone scans.
Apalutamide: 240mg tablet daily for 36 weeks
Androgen deprivation: ADT will consist of treatment with a GnRH agonist or antagonist per physician and institutional preference. Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix (Firmagon 120 mg or 240 mg SC) will be administered monthly, every 3 months, or every 6 months, depending on institutional standards, for 36 weeks total.
Salvage radiation therapy: On week 9 (+/- 28 days), subjects will begin salvage radiation therapy to the prostate bed. The total dose to the prostate bed must be 66-74 Gy in 1.8-2 Gy daily fractions over a total of 6-8 weeks
Docetaxel: About 4 weeks (+/- 2 weeks, pending recovery of adverse events from radiation to Grade 2 or less) after completing radiation, patients will start docetaxel 75mg/m2 intravenously, every 3 weeks for 6 cycles.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
A Salvage Trial of AR Inhibition With ADT and Apalutamide With Radiation Therapy Followed by Docetaxel in Men With PSA Recurrent Prostate Cancer After Radical Prostatectomy (STARTAR)
Baseline characteristics by cohort
| Measure |
Recurrent PSA-only Non-metastatic Prostate Cancer
n=39 Participants
Subjects with recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of greater than 0.2 ng/mL and less than 4 ng/mL in the absence of metastatic disease on CT and bone scans.
Apalutamide: 240mg tablet daily for 36 weeks
Androgen deprivation: ADT will consist of treatment with a GnRH agonist or antagonist per physician and institutional preference. Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix (Firmagon 120 mg or 240 mg SC) will be administered monthly, every 3 months, or every 6 months, depending on institutional standards, for 36 weeks total.
Salvage radiation therapy: On week 9 (+/- 28 days), subjects will begin salvage radiation therapy to the prostate bed. The total dose to the prostate bed must be 66-74 Gy in 1.8-2 Gy daily fractions over a total of 6-8 weeks
Docetaxel: About 4 weeks (+/- 2 weeks, pending recovery of adverse events from radiation to Grade 2 or less) after completing radiation, patients will start docetaxel 75mg/m2 intravenously, every 3 weeks for 6 cycles.
|
|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 6.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
39 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 36 monthsThe percentage of subjects with testosterone \>100 ng/dl at 36 months post-Cycle 1 Day 1 without one or more of the following: Serum PSA value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed (at least) 4 weeks later by a second PSA measurement higher than the first by any amount; Continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks; Evidence of clinical progression or initiation of systemic therapy for progressive disease; Death
Outcome measures
| Measure |
Recurrent PSA-only Non-metastatic Prostate Cancer
n=39 Participants
Subjects with recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of greater than 0.2 ng/mL and less than 4 ng/mL in the absence of metastatic disease on CT and bone scans.
Apalutamide: 240mg tablet daily for 36 weeks
Androgen deprivation: ADT will consist of treatment with a GnRH agonist or antagonist per physician and institutional preference. Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix (Firmagon 120 mg or 240 mg SC) will be administered monthly, every 3 months, or every 6 months, depending on institutional standards, for 36 weeks total.
Salvage radiation therapy: On week 9 (+/- 28 days), subjects will begin salvage radiation therapy to the prostate bed. The total dose to the prostate bed must be 66-74 Gy in 1.8-2 Gy daily fractions over a total of 6-8 weeks
Docetaxel: About 4 weeks (+/- 2 weeks, pending recovery of adverse events from radiation to Grade 2 or less) after completing radiation, patients will start docetaxel 75mg/m2 intravenously, every 3 weeks for 6 cycles.
|
|---|---|
|
Progression-free Survival (PFS) at 36 Months (3 Years)
|
69.2 percentage of participants
Interval 56.5 to 86.5
|
SECONDARY outcome
Timeframe: 12 monthsTestosterone recovery defined as testosterone \>100 ng/dl
Outcome measures
| Measure |
Recurrent PSA-only Non-metastatic Prostate Cancer
n=39 Participants
Subjects with recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of greater than 0.2 ng/mL and less than 4 ng/mL in the absence of metastatic disease on CT and bone scans.
Apalutamide: 240mg tablet daily for 36 weeks
Androgen deprivation: ADT will consist of treatment with a GnRH agonist or antagonist per physician and institutional preference. Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix (Firmagon 120 mg or 240 mg SC) will be administered monthly, every 3 months, or every 6 months, depending on institutional standards, for 36 weeks total.
Salvage radiation therapy: On week 9 (+/- 28 days), subjects will begin salvage radiation therapy to the prostate bed. The total dose to the prostate bed must be 66-74 Gy in 1.8-2 Gy daily fractions over a total of 6-8 weeks
Docetaxel: About 4 weeks (+/- 2 weeks, pending recovery of adverse events from radiation to Grade 2 or less) after completing radiation, patients will start docetaxel 75mg/m2 intravenously, every 3 weeks for 6 cycles.
|
|---|---|
|
Number of Participants With a PSA of <0.1 ng/mL and Testosterone Recovery at 12 Months Post-Cycle 1 Day 1
|
38 Participants
|
SECONDARY outcome
Timeframe: 24 monthsTestosterone recovery defined as testosterone \>100 ng/dl
Outcome measures
| Measure |
Recurrent PSA-only Non-metastatic Prostate Cancer
n=39 Participants
Subjects with recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of greater than 0.2 ng/mL and less than 4 ng/mL in the absence of metastatic disease on CT and bone scans.
Apalutamide: 240mg tablet daily for 36 weeks
Androgen deprivation: ADT will consist of treatment with a GnRH agonist or antagonist per physician and institutional preference. Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix (Firmagon 120 mg or 240 mg SC) will be administered monthly, every 3 months, or every 6 months, depending on institutional standards, for 36 weeks total.
Salvage radiation therapy: On week 9 (+/- 28 days), subjects will begin salvage radiation therapy to the prostate bed. The total dose to the prostate bed must be 66-74 Gy in 1.8-2 Gy daily fractions over a total of 6-8 weeks
Docetaxel: About 4 weeks (+/- 2 weeks, pending recovery of adverse events from radiation to Grade 2 or less) after completing radiation, patients will start docetaxel 75mg/m2 intravenously, every 3 weeks for 6 cycles.
|
|---|---|
|
Percentage of Participants With a PSA of <0.1 ng/mL and Testosterone Recovery at 24 Months Post-Cycle 1 Day 1
|
67 percentage of participants
|
SECONDARY outcome
Timeframe: 36 monthsTestosterone recovery defined as testosterone \>100 ng/dl
Outcome measures
| Measure |
Recurrent PSA-only Non-metastatic Prostate Cancer
n=39 Participants
Subjects with recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of greater than 0.2 ng/mL and less than 4 ng/mL in the absence of metastatic disease on CT and bone scans.
Apalutamide: 240mg tablet daily for 36 weeks
Androgen deprivation: ADT will consist of treatment with a GnRH agonist or antagonist per physician and institutional preference. Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix (Firmagon 120 mg or 240 mg SC) will be administered monthly, every 3 months, or every 6 months, depending on institutional standards, for 36 weeks total.
Salvage radiation therapy: On week 9 (+/- 28 days), subjects will begin salvage radiation therapy to the prostate bed. The total dose to the prostate bed must be 66-74 Gy in 1.8-2 Gy daily fractions over a total of 6-8 weeks
Docetaxel: About 4 weeks (+/- 2 weeks, pending recovery of adverse events from radiation to Grade 2 or less) after completing radiation, patients will start docetaxel 75mg/m2 intravenously, every 3 weeks for 6 cycles.
|
|---|---|
|
Percentage of Participants With a PSA of <0.1 ng/mL and Testosterone Recovery at 36 Months Post-Cycle 1 Day 1
|
69 percentage of participants
|
SECONDARY outcome
Timeframe: 36 monthsPercentage of participants still alive without disease progression based on PSA (prostate-specific antigen) only. Must have serum PSA value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed (at least) 4 weeks later by a second PSA measurement higher than the first by any amount.
Outcome measures
| Measure |
Recurrent PSA-only Non-metastatic Prostate Cancer
n=39 Participants
Subjects with recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of greater than 0.2 ng/mL and less than 4 ng/mL in the absence of metastatic disease on CT and bone scans.
Apalutamide: 240mg tablet daily for 36 weeks
Androgen deprivation: ADT will consist of treatment with a GnRH agonist or antagonist per physician and institutional preference. Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix (Firmagon 120 mg or 240 mg SC) will be administered monthly, every 3 months, or every 6 months, depending on institutional standards, for 36 weeks total.
Salvage radiation therapy: On week 9 (+/- 28 days), subjects will begin salvage radiation therapy to the prostate bed. The total dose to the prostate bed must be 66-74 Gy in 1.8-2 Gy daily fractions over a total of 6-8 weeks
Docetaxel: About 4 weeks (+/- 2 weeks, pending recovery of adverse events from radiation to Grade 2 or less) after completing radiation, patients will start docetaxel 75mg/m2 intravenously, every 3 weeks for 6 cycles.
|
|---|---|
|
Biochemical Progression-free Survival (PFS) at 36 Months (3 Years)
|
69.2 percentage of participants
Interval 56.5 to 86.5
|
SECONDARY outcome
Timeframe: 36 monthsMedian PSA nadir value
Outcome measures
| Measure |
Recurrent PSA-only Non-metastatic Prostate Cancer
n=39 Participants
Subjects with recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of greater than 0.2 ng/mL and less than 4 ng/mL in the absence of metastatic disease on CT and bone scans.
Apalutamide: 240mg tablet daily for 36 weeks
Androgen deprivation: ADT will consist of treatment with a GnRH agonist or antagonist per physician and institutional preference. Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix (Firmagon 120 mg or 240 mg SC) will be administered monthly, every 3 months, or every 6 months, depending on institutional standards, for 36 weeks total.
Salvage radiation therapy: On week 9 (+/- 28 days), subjects will begin salvage radiation therapy to the prostate bed. The total dose to the prostate bed must be 66-74 Gy in 1.8-2 Gy daily fractions over a total of 6-8 weeks
Docetaxel: About 4 weeks (+/- 2 weeks, pending recovery of adverse events from radiation to Grade 2 or less) after completing radiation, patients will start docetaxel 75mg/m2 intravenously, every 3 weeks for 6 cycles.
|
|---|---|
|
Median PSA Nadir Value
|
NA ng/mL
Standard Deviation NA
Below the level of detection.
|
SECONDARY outcome
Timeframe: up to 36 monthsTestosterone recovery defined as testosterone \>100 ng/dl
Outcome measures
| Measure |
Recurrent PSA-only Non-metastatic Prostate Cancer
n=39 Participants
Subjects with recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of greater than 0.2 ng/mL and less than 4 ng/mL in the absence of metastatic disease on CT and bone scans.
Apalutamide: 240mg tablet daily for 36 weeks
Androgen deprivation: ADT will consist of treatment with a GnRH agonist or antagonist per physician and institutional preference. Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix (Firmagon 120 mg or 240 mg SC) will be administered monthly, every 3 months, or every 6 months, depending on institutional standards, for 36 weeks total.
Salvage radiation therapy: On week 9 (+/- 28 days), subjects will begin salvage radiation therapy to the prostate bed. The total dose to the prostate bed must be 66-74 Gy in 1.8-2 Gy daily fractions over a total of 6-8 weeks
Docetaxel: About 4 weeks (+/- 2 weeks, pending recovery of adverse events from radiation to Grade 2 or less) after completing radiation, patients will start docetaxel 75mg/m2 intravenously, every 3 weeks for 6 cycles.
|
|---|---|
|
Time to Testosterone Recovery
|
15 months
Interval 13.0 to 17.0
|
SECONDARY outcome
Timeframe: up to 36 monthsTo describe the safety, feasibility and tolerability profile of combination apalutamide, ADT, and radiation therapy followed by apalutamide, ADT, and docetaxel as assessed by NCI common toxicity scales
Outcome measures
| Measure |
Recurrent PSA-only Non-metastatic Prostate Cancer
n=39 Participants
Subjects with recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of greater than 0.2 ng/mL and less than 4 ng/mL in the absence of metastatic disease on CT and bone scans.
Apalutamide: 240mg tablet daily for 36 weeks
Androgen deprivation: ADT will consist of treatment with a GnRH agonist or antagonist per physician and institutional preference. Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix (Firmagon 120 mg or 240 mg SC) will be administered monthly, every 3 months, or every 6 months, depending on institutional standards, for 36 weeks total.
Salvage radiation therapy: On week 9 (+/- 28 days), subjects will begin salvage radiation therapy to the prostate bed. The total dose to the prostate bed must be 66-74 Gy in 1.8-2 Gy daily fractions over a total of 6-8 weeks
Docetaxel: About 4 weeks (+/- 2 weeks, pending recovery of adverse events from radiation to Grade 2 or less) after completing radiation, patients will start docetaxel 75mg/m2 intravenously, every 3 weeks for 6 cycles.
|
|---|---|
|
Percentage of Participants With Adverse Events as Assessed by CTCAE v4.0
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: 36 monthsTo describe the percentage of participants completing all treatments including salvage radiation therapy and 6 cycles of docetaxel
Outcome measures
| Measure |
Recurrent PSA-only Non-metastatic Prostate Cancer
n=39 Participants
Subjects with recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of greater than 0.2 ng/mL and less than 4 ng/mL in the absence of metastatic disease on CT and bone scans.
Apalutamide: 240mg tablet daily for 36 weeks
Androgen deprivation: ADT will consist of treatment with a GnRH agonist or antagonist per physician and institutional preference. Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix (Firmagon 120 mg or 240 mg SC) will be administered monthly, every 3 months, or every 6 months, depending on institutional standards, for 36 weeks total.
Salvage radiation therapy: On week 9 (+/- 28 days), subjects will begin salvage radiation therapy to the prostate bed. The total dose to the prostate bed must be 66-74 Gy in 1.8-2 Gy daily fractions over a total of 6-8 weeks
Docetaxel: About 4 weeks (+/- 2 weeks, pending recovery of adverse events from radiation to Grade 2 or less) after completing radiation, patients will start docetaxel 75mg/m2 intravenously, every 3 weeks for 6 cycles.
|
|---|---|
|
Percentage of Participants Completing All Treatments
|
97.4 percentage of participants
|
Adverse Events
Recurrent PSA-only Non-metastatic Prostate Cancer
Serious events: 4 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Recurrent PSA-only Non-metastatic Prostate Cancer
n=39 participants at risk
Subjects with recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of greater than 0.2 ng/mL and less than 4 ng/mL in the absence of metastatic disease on CT and bone scans.
Apalutamide: 240mg tablet daily for 36 weeks
Androgen deprivation: ADT will consist of treatment with a GnRH agonist or antagonist per physician and institutional preference. Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix (Firmagon 120 mg or 240 mg SC) will be administered monthly, every 3 months, or every 6 months, depending on institutional standards, for 36 weeks total.
Salvage radiation therapy: On week 9 (+/- 28 days), subjects will begin salvage radiation therapy to the prostate bed. The total dose to the prostate bed must be 66-74 Gy in 1.8-2 Gy daily fractions over a total of 6-8 weeks
Docetaxel: About 4 weeks (+/- 2 weeks, pending recovery of adverse events from radiation to Grade 2 or less) after completing radiation, patients will start docetaxel 75mg/m2 intravenously, every 3 weeks for 6 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Fever
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Flu like symptoms
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Hematoma
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Pelvic infection
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Cardiac disorders
Sinus tachycardia
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Thromboembolic event
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
Other adverse events
| Measure |
Recurrent PSA-only Non-metastatic Prostate Cancer
n=39 participants at risk
Subjects with recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of greater than 0.2 ng/mL and less than 4 ng/mL in the absence of metastatic disease on CT and bone scans.
Apalutamide: 240mg tablet daily for 36 weeks
Androgen deprivation: ADT will consist of treatment with a GnRH agonist or antagonist per physician and institutional preference. Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix (Firmagon 120 mg or 240 mg SC) will be administered monthly, every 3 months, or every 6 months, depending on institutional standards, for 36 weeks total.
Salvage radiation therapy: On week 9 (+/- 28 days), subjects will begin salvage radiation therapy to the prostate bed. The total dose to the prostate bed must be 66-74 Gy in 1.8-2 Gy daily fractions over a total of 6-8 weeks
Docetaxel: About 4 weeks (+/- 2 weeks, pending recovery of adverse events from radiation to Grade 2 or less) after completing radiation, patients will start docetaxel 75mg/m2 intravenously, every 3 weeks for 6 cycles.
|
|---|---|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, Specify
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Blood and lymphatic system disorders
Anemia
|
64.1%
25/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Cardiac disorders
Palpitations
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, Specify
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Ear and labyrinth disorders
Ear pain
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Ear and labyrinth disorders
Tinnitus
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Endocrine disorders
Hypothyroidism
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Blurred vision
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Conjunctivitis
|
7.7%
3/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Dry eye
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Eye disorders - Other, Specify
|
7.7%
3/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Photophobia
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Eye disorders
Watering eyes
|
12.8%
5/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Abdominal pain
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Anal pain
|
7.7%
3/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Bloating
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Constipation
|
25.6%
10/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Diarrhea
|
43.6%
17/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Dry mouth
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Dyspepsia
|
12.8%
5/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Flatulence
|
10.3%
4/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Gastritis
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Specify
|
15.4%
6/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Hemorrhoids
|
12.8%
5/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Mucositis oral
|
28.2%
11/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Nausea
|
43.6%
17/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Oral dysesthesia
|
7.7%
3/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Proctitis
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Rectal pain
|
7.7%
3/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Stomach pain
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Chills
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Edema face
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Edema limbs
|
30.8%
12/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Fatigue
|
89.7%
35/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Fever
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Flu like symptoms
|
15.4%
6/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
General disorders and administration site conditions - Other, Specify
|
20.5%
8/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Infusion related reaction
|
12.8%
5/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Localized edema
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Malaise
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Non-cardiac chest pain
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Pain
|
17.9%
7/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Immune system disorders
Allergic reaction
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Immune system disorders
Infections and infestations - Other, Specify
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Immune system disorders
Mucosal infection
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Immune system disorders
Otitis externa
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Immune system disorders
Papulopustular rash
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Immune system disorders
Pelvic infection
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Immune system disorders
Penile infection
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Immune system disorders
Skin infection
|
10.3%
4/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Immune system disorders
Upper respiratory infection
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Immune system disorders
Urinary tract infection
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Injury, poisoning and procedural complications
Bruising
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
3/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
3/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Aspartate aminotransferase increased
|
10.3%
4/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Creatinine increased
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Lymphocyte count decreased
|
15.4%
6/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Neutrophil count decreased
|
82.1%
32/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Platelet count decreased
|
17.9%
7/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Weight gain
|
15.4%
6/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Weight loss
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
White blood cell decreased
|
84.6%
33/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Alkalosis
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Anorexia
|
23.1%
9/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Hypercalcemia
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Hypoalbuminemia
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Hypokalemia
|
30.8%
12/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Hypomagnesemia
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Hyponatremia
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
13/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
6/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
3/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
23.1%
9/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other Specify
|
12.8%
5/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.2%
11/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.4%
6/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Cognitive disturbance
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Concentration impairment
|
17.9%
7/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Dizziness
|
15.4%
6/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Dysesthesia
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Dysgeusia
|
59.0%
23/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Headache
|
23.1%
9/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Lethargy
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Memory impairment
|
10.3%
4/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Nervous system disorders - Other, Specify
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Neuralgia
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Paresthesia
|
35.9%
14/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.8%
5/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Presyncope
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Radiculitis
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Sinus pain
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Syncope
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Tremor
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Agitation
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Anxiety
|
20.5%
8/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Confusion
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Depression
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Insomnia
|
46.2%
18/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Libido decreased
|
7.7%
3/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Psychiatric disorders - Other, Specify
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Restlessness
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Cystitis noninfective
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Hematuria
|
7.7%
3/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Specify
|
10.3%
4/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Urinary frequency
|
46.2%
18/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Urinary incontinence
|
23.1%
9/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Urinary retention
|
7.7%
3/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Urinary tract pain
|
23.1%
9/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Urinary urgency
|
38.5%
15/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Reproductive system and breast disorders
Breast pain
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Reproductive system and breast disorders
Gynecomastia
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Reproductive system and breast disorders
Perineal pain
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Reproductive system and breast disorders
Testicular disorder
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Reproductive system and breast disorders
Testicular pain
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
6/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
38.5%
15/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.4%
6/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
3/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
7.7%
3/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
76.9%
30/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.6%
10/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
15.4%
6/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
23.1%
9/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
13/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
53.8%
21/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify
|
33.3%
13/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, Specify
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Flushing
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Hematoma
|
2.6%
1/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Hot flashes
|
100.0%
39/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Hypertension
|
10.3%
4/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Hypotension
|
7.7%
3/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Phlebitis
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Superficial thrombophlebitis
|
5.1%
2/39 • 36 months
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place