Trial Outcomes & Findings for Apalutamide and Gonadotropin-Releasing Hormone Analog With or Without Abiraterone Acetate in Treating Participants With Prostate Cancer (NCT NCT03279250)
NCT ID: NCT03279250
Last Updated: 2022-08-10
Results Overview
The study will provide a point estimate and 95% confidence interval of the proportion of patients with pathologic stage =\< pT2N0 at prostatectomy for each arm. Patient characteristics will be summarized using descriptive statistics for each arm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
86 participants
Primary outcome timeframe
At the time of radical prostatectomy
Results posted on
2022-08-10
Participant Flow
86 participants signed consent, 18 participants were not randomized (10 screen failures, 3 Insurance complications, 5 consent withdrawn )
Participant milestones
| Measure |
Arm A (LHRHa, Apalutamide)
Participants receive gonadotropin-releasing hormone analog (leuprolide, goserelin, or triptorelin as determined by treating physician) IM once every 3 months and apalutamide PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.
Apalutamide: Given PO
Gonadotropin-releasing Hormone Analog: Given IM
Radical Prostatectomy: Undergo radical prostatectomy
|
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
Participants receive gonadotropin-releasing hormone analog and apalutamide as in arm A, abiraterone acetate PO QD, and prednisone PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.
Abiraterone Acetate: Given PO
Apalutamide: Given PO
Gonadotropin-releasing Hormone Analog: Given IM
Prednisone: Given PO
Radical Prostatectomy: Undergo radical prostatectomy
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm A (LHRHa, Apalutamide)
n=34 Participants
Participants receive gonadotropin-releasing hormone analog (leuprolide, goserelin, or triptorelin as determined by treating physician) IM once every 3 months and apalutamide PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.
Apalutamide: Given PO
Gonadotropin-releasing Hormone Analog: Given IM
Radical Prostatectomy: Undergo radical prostatectomy
|
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
n=34 Participants
Participants receive gonadotropin-releasing hormone analog and apalutamide as in arm A, abiraterone acetate PO QD, and prednisone PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.
Abiraterone Acetate: Given PO
Apalutamide: Given PO
Gonadotropin-releasing Hormone Analog: Given IM
Prednisone: Given PO
Radical Prostatectomy: Undergo radical prostatectomy
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=34 Participants
|
62 years
n=34 Participants
|
63 years
n=68 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=34 Participants
|
34 Participants
n=34 Participants
|
68 Participants
n=68 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
34 participants
n=34 Participants
|
34 participants
n=34 Participants
|
68 participants
n=68 Participants
|
PRIMARY outcome
Timeframe: At the time of radical prostatectomyThe study will provide a point estimate and 95% confidence interval of the proportion of patients with pathologic stage =\< pT2N0 at prostatectomy for each arm. Patient characteristics will be summarized using descriptive statistics for each arm.
Outcome measures
| Measure |
Arm A (LHRHa, Apalutamide)
n=32 Participants
Participants receive gonadotropin-releasing hormone analog (leuprolide, goserelin, or triptorelin as determined by treating physician) IM once every 3 months and apalutamide PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.
|
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
n=31 Participants
Participants receive gonadotropin-releasing hormone analog and apalutamide as in arm A, abiraterone acetate PO QD, and prednisone PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.
|
|---|---|---|
|
The Number of Participants With Rate of Pathologic Stage =< pT2N0 at Prostatectomy
|
13 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: From screening up to 4 weeks post-surgery, an average of 7 monthsWill be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Incidence of serious adverse events and 95% confidence interval will be provided overall as well as for each major affected organ category.
Outcome measures
| Measure |
Arm A (LHRHa, Apalutamide)
n=34 Participants
Participants receive gonadotropin-releasing hormone analog (leuprolide, goserelin, or triptorelin as determined by treating physician) IM once every 3 months and apalutamide PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.
|
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
n=34 Participants
Participants receive gonadotropin-releasing hormone analog and apalutamide as in arm A, abiraterone acetate PO QD, and prednisone PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.
|
|---|---|---|
|
Number of Participants With Incidence of Adverse Events
Serious
|
1 Participants
|
2 Participants
|
|
Number of Participants With Incidence of Adverse Events
Non Serious
|
34 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: At the time of radical prostatectomyPopulation: Tumor epithelium volume in the surgical specimen analysis is unavailable due to no data collected.
Tumor volume will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Secondary categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the time of radical prostatectomyPopulation: Assessment of positive surgical margins in the surgical specimen analysis is not available due to no data collected.
Presence of positive surgical margins will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Secondary categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of randomization up to 4 weeks post-surgeryPopulation: Time to prostate specific antigen recurrence (TTRPSA) analysis is not available due to no data collected.
TTRPSA will be summarized by Kaplan-Meier estimates and confidence intervals. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Secondary categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At radical prostatectomySteroid hormone metabolome in blood plasma and tissue will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Exploratory categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At radical prostatectomyAssessment of protein and RNA analysis results will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Exploratory categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At radical prostatectomyCitrate intracellular TCA cycle metabolite concentrations will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Exploratory categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 4 weeks post-surgeryPathological response will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Exploratory categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 4 weeks post-surgeryHyperpolarized 1-13C-pyruvate imaging results will be summarized descriptively and graphically. Comparisons between two the arms or patient subgroups will use a t-test or non-parametric alternative as indicated. Exploratory categorical endpoints will be summarized using proportions with 95% confidence intervals. Comparisons between the two arms will use a chi-square test or Fisher's exact if indicated.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (LHRHa, Apalutamide)
Serious events: 1 serious events
Other events: 34 other events
Deaths: 1 deaths
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
Serious events: 2 serious events
Other events: 34 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A (LHRHa, Apalutamide)
n=34 participants at risk
Participants receive gonadotropin-releasing hormone analog (leuprolide, goserelin, or triptorelin as determined by treating physician) IM once every 3 months and apalutamide PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.
Apalutamide: Given PO
Gonadotropin-releasing Hormone Analog: Given IM
Radical Prostatectomy: Undergo radical prostatectomy
|
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
n=34 participants at risk
Participants receive gonadotropin-releasing hormone analog and apalutamide as in arm A, abiraterone acetate PO QD, and prednisone PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.
Abiraterone Acetate: Given PO
Apalutamide: Given PO
Gonadotropin-releasing Hormone Analog: Given IM
Prednisone: Given PO
Radical Prostatectomy: Undergo radical prostatectomy
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/34 • From screening up to 4 weeks post-surgery, an average of 7 months
|
2.9%
1/34 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/34 • From screening up to 4 weeks post-surgery, an average of 7 months
|
2.9%
1/34 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Nervous system disorders
Syncope
|
2.9%
1/34 • From screening up to 4 weeks post-surgery, an average of 7 months
|
0.00%
0/34 • From screening up to 4 weeks post-surgery, an average of 7 months
|
Other adverse events
| Measure |
Arm A (LHRHa, Apalutamide)
n=34 participants at risk
Participants receive gonadotropin-releasing hormone analog (leuprolide, goserelin, or triptorelin as determined by treating physician) IM once every 3 months and apalutamide PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.
Apalutamide: Given PO
Gonadotropin-releasing Hormone Analog: Given IM
Radical Prostatectomy: Undergo radical prostatectomy
|
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
n=34 participants at risk
Participants receive gonadotropin-releasing hormone analog and apalutamide as in arm A, abiraterone acetate PO QD, and prednisone PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.
Abiraterone Acetate: Given PO
Apalutamide: Given PO
Gonadotropin-releasing Hormone Analog: Given IM
Prednisone: Given PO
Radical Prostatectomy: Undergo radical prostatectomy
|
|---|---|---|
|
Investigations
ALT increase
|
8.8%
3/34 • Number of events 5 • From screening up to 4 weeks post-surgery, an average of 7 months
|
23.5%
8/34 • Number of events 14 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.8%
3/34 • Number of events 3 • From screening up to 4 weeks post-surgery, an average of 7 months
|
0.00%
0/34 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Blood and lymphatic system disorders
Anemia
|
61.8%
21/34 • Number of events 28 • From screening up to 4 weeks post-surgery, an average of 7 months
|
44.1%
15/34 • Number of events 19 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Metabolism and nutrition disorders
Anorexia
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
2.9%
1/34 • Number of events 1 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Psychiatric disorders
Anxiety
|
11.8%
4/34 • Number of events 4 • From screening up to 4 weeks post-surgery, an average of 7 months
|
2.9%
1/34 • Number of events 1 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.5%
8/34 • Number of events 8 • From screening up to 4 weeks post-surgery, an average of 7 months
|
8.8%
3/34 • Number of events 3 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Investigations
AST increase
|
11.8%
4/34 • Number of events 5 • From screening up to 4 weeks post-surgery, an average of 7 months
|
26.5%
9/34 • Number of events 14 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Injury, poisoning and procedural complications
Bruising
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
2.9%
1/34 • Number of events 1 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Investigations
Cholesterol high
|
32.4%
11/34 • Number of events 12 • From screening up to 4 weeks post-surgery, an average of 7 months
|
17.6%
6/34 • Number of events 7 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Nervous system disorders
Cognitive disturbance
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
0.00%
0/34 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Gastrointestinal disorders
Constipation
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
11.8%
4/34 • Number of events 4 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Nervous system disorders
Dizziness
|
26.5%
9/34 • Number of events 9 • From screening up to 4 weeks post-surgery, an average of 7 months
|
14.7%
5/34 • Number of events 6 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
41.2%
14/34 • Number of events 14 • From screening up to 4 weeks post-surgery, an average of 7 months
|
23.5%
8/34 • Number of events 8 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Nervous system disorders
Dysgeusia
|
11.8%
4/34 • Number of events 4 • From screening up to 4 weeks post-surgery, an average of 7 months
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
1/34 • Number of events 1 • From screening up to 4 weeks post-surgery, an average of 7 months
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Endocrine disorders
HbA1c increased
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Endocrine disorders
TSH increased
|
26.5%
9/34 • Number of events 11 • From screening up to 4 weeks post-surgery, an average of 7 months
|
2.9%
1/34 • Number of events 1 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
8.8%
3/34 • Number of events 3 • From screening up to 4 weeks post-surgery, an average of 7 months
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
0.00%
0/34 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
General disorders
Fatigue
|
88.2%
30/34 • Number of events 36 • From screening up to 4 weeks post-surgery, an average of 7 months
|
70.6%
24/34 • Number of events 27 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Gastrointestinal disorders
GERD
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
0.00%
0/34 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
0.00%
0/34 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Nervous system disorders
Headache
|
23.5%
8/34 • Number of events 9 • From screening up to 4 weeks post-surgery, an average of 7 months
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Vascular disorders
Hot flashes
|
91.2%
31/34 • Number of events 40 • From screening up to 4 weeks post-surgery, an average of 7 months
|
73.5%
25/34 • Number of events 31 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
2.9%
1/34 • Number of events 1 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
47.1%
16/34 • Number of events 17 • From screening up to 4 weeks post-surgery, an average of 7 months
|
38.2%
13/34 • Number of events 15 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Vascular disorders
Hypertension
|
14.7%
5/34 • Number of events 6 • From screening up to 4 weeks post-surgery, an average of 7 months
|
26.5%
9/34 • Number of events 14 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
26.5%
9/34 • Number of events 11 • From screening up to 4 weeks post-surgery, an average of 7 months
|
5.9%
2/34 • Number of events 3 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Endocrine disorders
Hypothyrodism
|
8.8%
3/34 • Number of events 4 • From screening up to 4 weeks post-surgery, an average of 7 months
|
8.8%
3/34 • Number of events 3 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Psychiatric disorders
Insomnia
|
29.4%
10/34 • Number of events 12 • From screening up to 4 weeks post-surgery, an average of 7 months
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
General disorders
Irritability
|
11.8%
4/34 • Number of events 5 • From screening up to 4 weeks post-surgery, an average of 7 months
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Investigations
Lipase increase
|
20.6%
7/34 • Number of events 11 • From screening up to 4 weeks post-surgery, an average of 7 months
|
26.5%
9/34 • Number of events 17 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Investigations
Lymphocyte count decrease
|
5.9%
2/34 • Number of events 4 • From screening up to 4 weeks post-surgery, an average of 7 months
|
11.8%
4/34 • Number of events 4 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Nervous system disorders
Memory impairment
|
20.6%
7/34 • Number of events 7 • From screening up to 4 weeks post-surgery, an average of 7 months
|
11.8%
4/34 • Number of events 4 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Metabolism and nutrition disorders
ACTH increase
|
0.00%
0/34 • From screening up to 4 weeks post-surgery, an average of 7 months
|
17.6%
6/34 • Number of events 8 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Metabolism and nutrition disorders
Insulin increase
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
0.00%
0/34 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Metabolism and nutrition disorders
LDH increase
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
8.8%
3/34 • Number of events 3 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Metabolism and nutrition disorders
Vitamin D decrease
|
5.9%
2/34 • Number of events 4 • From screening up to 4 weeks post-surgery, an average of 7 months
|
0.00%
0/34 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.9%
1/34 • Number of events 1 • From screening up to 4 weeks post-surgery, an average of 7 months
|
8.8%
3/34 • Number of events 5 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Gastrointestinal disorders
Nausea
|
11.8%
4/34 • Number of events 4 • From screening up to 4 weeks post-surgery, an average of 7 months
|
0.00%
0/34 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Nervous system disorders
Paresthesia
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
8.8%
3/34 • Number of events 3 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Psychiatric disorders
Personality change
|
2.9%
1/34 • Number of events 1 • From screening up to 4 weeks post-surgery, an average of 7 months
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
29.4%
10/34 • Number of events 11 • From screening up to 4 weeks post-surgery, an average of 7 months
|
20.6%
7/34 • Number of events 11 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Investigations
Amylase increase
|
11.8%
4/34 • Number of events 7 • From screening up to 4 weeks post-surgery, an average of 7 months
|
14.7%
5/34 • Number of events 13 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Investigations
Weight loss
|
5.9%
2/34 • Number of events 2 • From screening up to 4 weeks post-surgery, an average of 7 months
|
8.8%
3/34 • Number of events 5 • From screening up to 4 weeks post-surgery, an average of 7 months
|
|
Investigations
White blood cell decrease
|
11.8%
4/34 • Number of events 6 • From screening up to 4 weeks post-surgery, an average of 7 months
|
11.8%
4/34 • Number of events 4 • From screening up to 4 weeks post-surgery, an average of 7 months
|
Additional Information
Dr. Christopher Logothetis, MD-Professor, Genitourinary Medical Oncology
UT MD Anderson Cancer Center
Phone: (713) 563-7210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place