Trial Outcomes & Findings for Androgen Deprivation Therapy Prior to Prostatectomy for Patients With Intermediate and High Risk Prostate Cancer (NCT NCT01542021)
NCT ID: NCT01542021
Last Updated: 2026-07-29
Results Overview
The primary endpoint is the change in the rate of proliferation (Ki-67), as evaluated by IHC in anatomically matched tumor foci from the pre-treatment diagnostic biopsy and the RP specimen. The levels in pre-treatment biopsy serve as the baseline. Ki-67 is a widely accepted nuclear marker for cell proliferation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Baseline and up to 2 years
Results posted on
2026-07-29
Participant Flow
3 participants withdrew consent and were not treated
Participant milestones
| Measure |
Untreated Patients Degarelix Injection Occur at Days 4± 1
Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy, depending on treatment arm.
|
Untreated Patients Degarelix Injection Occur at Days and 7± 1.
Treatment will consist of a single 240 mg injection of degarelix 7±1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.
|
Untreated Patients With Androgen Deprivation
Patients already treated with androgen deprivation are assigned to Cohort 3 and maintained on current androgen deprivation therapy until they undergo or have already undergone RP at MSKCC. Will include patients who have already undergone hormonal therapy (of any duration between 1 and 6 months) prior to prostatectomy.
androgen deprivation therapy
|
Untreated Patients Degarelix Injection Occur at Days 14±1
Treatment will consist of a single 240 mg injection of degarelix 14±1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
3
|
1
|
|
Overall Study
COMPLETED
|
17
|
17
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Androgen Deprivation Therapy Prior to Prostatectomy for Patients With Intermediate and High Risk Prostate Cancer
Baseline characteristics by cohort
| Measure |
Untreated Patients Degarelix Injection Occur at Days 4± 1
n=17 Participants
Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy, depending on treatment arm.
|
Untreated Patients Degarelix Injection Occur at Days and 7± 1.
n=17 Participants
Treatment will consist of a single 240 mg injection of degarelix 7±1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.
|
Untreated Patients With Androgen Deprivation
n=3 Participants
Patients already treated with androgen deprivation are assigned to Cohort 3 and maintained on current androgen deprivation therapy until they undergo or have already undergone RP at MSKCC. Will include patients who have already undergone hormonal therapy (of any duration between 1 and 6 months) prior to prostatectomy.
androgen deprivation therapy
|
Untreated Patients Degarelix Injection Occur at Days 14±1
n=1 Participants
Treatment will consist of a single 240 mg injection of degarelix 14±1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
70 years
n=9 Participants
|
76 years
n=27 Participants
|
69 years
n=267 Participants
|
53 years
n=265 Participants
|
72 years
n=568 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
38 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=9 Participants
|
15 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
34 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=9 Participants
|
13 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
31 Participants
n=568 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
38 Participants
n=568 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 2 yearsThe primary endpoint is the change in the rate of proliferation (Ki-67), as evaluated by IHC in anatomically matched tumor foci from the pre-treatment diagnostic biopsy and the RP specimen. The levels in pre-treatment biopsy serve as the baseline. Ki-67 is a widely accepted nuclear marker for cell proliferation.
Outcome measures
| Measure |
Untreated Patients Degarelix Injection Occur at Days 4± 1
n=17 Participants
Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy, depending on treatment arm.
|
Untreated Patients Degarelix Injection Occur at Days and 7± 1.
n=17 Participants
Treatment will consist of a single 240 mg injection of degarelix 7±1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.
|
Untreated Patients With Androgen Deprivation
n=3 Participants
Patients already treated with androgen deprivation are assigned to Cohort 3 and maintained on current androgen deprivation therapy until they undergo or have already undergone RP at MSKCC. Will include patients who have already undergone hormonal therapy (of any duration between 1 and 6 months) prior to prostatectomy.
androgen deprivation therapy
|
Untreated Patients Degarelix Injection Occur at Days 14±1
n=1 Participants
Treatment will consist of a single 240 mg injection of degarelix 14±1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.
|
|---|---|---|---|---|
|
Percent Change in Prostate Cancer Cell Proliferation (Ki-67 Levels)
|
32 percent change
Interval 9.0 to 42.0
|
27 percent change
Interval 3.0 to 39.0
|
88 percent change
Interval 88.0 to 88.0
|
NA percent change
Below the level of detection
|
SECONDARY outcome
Timeframe: up to 2 yearsThe secondary endpoint is PTEN status by IHC in the diagnostic biopsy and RP specimens. PTEN status will be determined by an IHC method that has been validated using control prostate cell lines and tissues at MSKCC. The PTEN status will be reported in binary fashion as "retained" (diffuse moderate immunoreactivity retained in benign glands as well as adenocarcinoma on 100X magnification) or "null" (complete loss of nuclear and cytoplasmic immunoreactivity in tumor cells while expression is retained in surrounding stroma.
Outcome measures
| Measure |
Untreated Patients Degarelix Injection Occur at Days 4± 1
n=17 Participants
Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy, depending on treatment arm.
|
Untreated Patients Degarelix Injection Occur at Days and 7± 1.
n=17 Participants
Treatment will consist of a single 240 mg injection of degarelix 7±1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.
|
Untreated Patients With Androgen Deprivation
n=3 Participants
Patients already treated with androgen deprivation are assigned to Cohort 3 and maintained on current androgen deprivation therapy until they undergo or have already undergone RP at MSKCC. Will include patients who have already undergone hormonal therapy (of any duration between 1 and 6 months) prior to prostatectomy.
androgen deprivation therapy
|
Untreated Patients Degarelix Injection Occur at Days 14±1
n=1 Participants
Treatment will consist of a single 240 mg injection of degarelix 14±1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.
|
|---|---|---|---|---|
|
Median Percentage of Cells From Biopsy and Surgery That Are Positive For Ki-67
Biopsy Ki-67
|
15 % positive cells
Interval 4.0 to 42.0
|
8 % positive cells
Interval 1.0 to 27.0
|
NA % positive cells
N/A-below the level of detection
|
NA % positive cells
N/A-below the level of detection
|
|
Median Percentage of Cells From Biopsy and Surgery That Are Positive For Ki-67
Surgery Ki-67
|
13 % positive cells
Interval 3.0 to 39.0
|
10 % positive cells
Interval 1.0 to 22.0
|
NA % positive cells
N/A-below the level of detection
|
NA % positive cells
N/A-below the level of detection
|
SECONDARY outcome
Timeframe: Up to 14+/- daysthrough expression profiling of prostate cancer after three time intervals of androgen deprivation therapy and correlate with PTEN and ERG status, proliferation rate, apoptotic rate, and histologic response
Outcome measures
| Measure |
Untreated Patients Degarelix Injection Occur at Days 4± 1
n=17 Participants
Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy, depending on treatment arm.
|
Untreated Patients Degarelix Injection Occur at Days and 7± 1.
n=17 Participants
Treatment will consist of a single 240 mg injection of degarelix 7±1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.
|
Untreated Patients With Androgen Deprivation
n=3 Participants
Patients already treated with androgen deprivation are assigned to Cohort 3 and maintained on current androgen deprivation therapy until they undergo or have already undergone RP at MSKCC. Will include patients who have already undergone hormonal therapy (of any duration between 1 and 6 months) prior to prostatectomy.
androgen deprivation therapy
|
Untreated Patients Degarelix Injection Occur at Days 14±1
n=1 Participants
Treatment will consist of a single 240 mg injection of degarelix 14±1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.
|
|---|---|---|---|---|
|
Record Participant Biomarker Results and Correlates of Response
KI-67 4 days, PTEN Loss
|
-3.6 % change
Interval -6.3 to -2.3
|
-13.9 % change
Interval -23.2 to -8.2
|
NA % change
N/A-insufficient levels detected
|
NA % change
Participant was not treated at MSK
|
|
Record Participant Biomarker Results and Correlates of Response
CC3 4 days, PTEN Loss
|
2.8 % change
Interval 1.9 to 4.5
|
6.2 % change
Interval 4.8 to 9.3
|
NA % change
N/A-insufficient levels detected
|
NA % change
Participant was not treated at MSK
|
|
Record Participant Biomarker Results and Correlates of Response
CC3 4 days, PTEN Retained
|
4 % change
Interval 0.3 to 4.5
|
1.6 % change
Interval 0.1 to 2.4
|
NA % change
N/A-insufficient levels detected
|
NA % change
Participant was not treated at MSK
|
|
Record Participant Biomarker Results and Correlates of Response
KI-67 4 days, PTEN Retained
|
-5.8 % change
Interval -9.2 to -2.3
|
-4.7 % change
Interval -7.5 to -0.1
|
NA % change
N/A-insufficient levels detected
|
NA % change
Participant was not treated at MSK
|
POST_HOC outcome
Timeframe: 2 yearsPopulation: N/A - this outcome was an exploratory outcome
Additional exploratory endpoints include IHC staining for markers of PI3K pathway (pAKT and pS6) as well as other markers of prostate cancer (ERG, AR and NCOA2) in the diagnostic biopsy and RP specimens. Some of these markers have been validated at MSKCC (pS6, ERG), while others (AR, pAKT, NCOA2) are currently being validated and standardized for the study using appropriate cell line and tissue controls. A general semiquantitative scoring method will be used for these markers.
Outcome measures
Outcome data not reported
Adverse Events
Untreated Patients Degarelix Injection Occur at Days 4± 1
Serious events: 7 serious events
Other events: 13 other events
Deaths: 2 deaths
Untreated Patients Degarelix Injection Occur at Days and 7± 1.
Serious events: 5 serious events
Other events: 17 other events
Deaths: 0 deaths
Untreated Patients With Androgen Deprivation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Untreated Patients Degarelix Injection Occur at Days 14±1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Untreated Patients Degarelix Injection Occur at Days 4± 1
n=17 participants at risk
Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy, depending on treatment arm.
|
Untreated Patients Degarelix Injection Occur at Days and 7± 1.
n=17 participants at risk
Treatment will consist of a single 240 mg injection of degarelix 7±1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.
|
Untreated Patients With Androgen Deprivation
n=3 participants at risk
Patients already treated with androgen deprivation are assigned to Cohort 3 and maintained on current androgen deprivation therapy until they undergo or have already undergone RP at MSKCC. Will include patients who have already undergone hormonal therapy (of any duration between 1 and 6 months) prior to prostatectomy.
androgen deprivation therapy
|
Untreated Patients Degarelix Injection Occur at Days 14±1
n=1 participants at risk
Treatment will consist of a single 240 mg injection of degarelix 14±1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
1/17 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
11.8%
2/17 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
11.8%
2/17 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
11.8%
2/17 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
General disorders
Chills
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
General disorders
Edema limbs
|
5.9%
1/17 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
General disorders
Fatigue
|
5.9%
1/17 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
General disorders
Fever
|
5.9%
1/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
General disorders
Pain
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Infections and infestations
Lymph gland infection
|
5.9%
1/17 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
11.8%
2/17 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.9%
1/17 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.9%
1/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Nervous system disorders
Brachial plexopathy
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
5.9%
1/17 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
5.9%
1/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/17 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Vascular disorders
Lymphocele
|
5.9%
1/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Vascular disorders
Thromboembolic event
|
5.9%
1/17 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
Other adverse events
| Measure |
Untreated Patients Degarelix Injection Occur at Days 4± 1
n=17 participants at risk
Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy, depending on treatment arm.
|
Untreated Patients Degarelix Injection Occur at Days and 7± 1.
n=17 participants at risk
Treatment will consist of a single 240 mg injection of degarelix 7±1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.
|
Untreated Patients With Androgen Deprivation
n=3 participants at risk
Patients already treated with androgen deprivation are assigned to Cohort 3 and maintained on current androgen deprivation therapy until they undergo or have already undergone RP at MSKCC. Will include patients who have already undergone hormonal therapy (of any duration between 1 and 6 months) prior to prostatectomy.
androgen deprivation therapy
|
Untreated Patients Degarelix Injection Occur at Days 14±1
n=1 participants at risk
Treatment will consist of a single 240 mg injection of degarelix 14±1 day before radical prostatectomy
degarelix injection: Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Pain in prostate area
|
0.00%
0/17 • 2 years
|
0.00%
0/17 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Renal and urinary disorders
Urinary Incontinence
|
11.8%
2/17 • 2 years
|
23.5%
4/17 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
5.9%
1/17 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Renal and urinary disorders
Nocturia
|
23.5%
4/17 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
General disorders
Fatigue
|
0.00%
0/17 • 2 years
|
11.8%
2/17 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Injury, poisoning and procedural complications
Hernia
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
5.9%
1/17 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
1/17 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Hand stiffness
|
5.9%
1/17 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Stiff neck
|
5.9%
1/17 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
0.00%
0/17 • 2 years
|
58.8%
10/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Renal and urinary disorders
Urethra Pain
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Maculopapular Rash
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Injury, poisoning and procedural complications
Right Inguinal hernia
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
General disorders
Fever
|
0.00%
0/17 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Vascular disorders
Hot Flashes
|
17.6%
3/17 • 2 years
|
5.9%
1/17 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/1 • 2 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
23.5%
4/17 • 2 years
|
17.6%
3/17 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/1 • 2 years
|
Additional Information
Dr. Dana Rathkopf, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-422-4379
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place