DRUG
degarelix injection
Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy, depending on treatment arm.
Status
Completed
Phase
Not applicable
Enrollment
41
Locations
1
Results
Posted
Publications
1
Study summary
Degarelix is an approved drug that is used to treat prostate cancer by lowering testosterone levels in the body. Degarelix is commonly given with radiation for prostate cancer, but less frequently with surgery since there has been no proven benefit with this approach. The investigators do not expect the patient to benefit directly from treatment with degarelix since their prostate will be removed shortly after the drug is given. Instead, the investigators hope to learn about how degarelix and other treatment that lowers your testosterone effects prostate cancer cells and use this information to develop better treatments in the future.
Interventions
DRUG
Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy, depending on treatment arm.
DRUG
Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.
DRUG
Timeline
First posted
Mar 1, 2012
Study start
Feb 24, 2012
Primary completion
Sep 30, 2024
Study completion
Sep 30, 2024
Results posted
Jul 29, 2026
Registry updated
Jul 29, 2026
Outcomes
Percent Change in Prostate Cancer Cell Proliferation (Ki-67 Levels)
Time frame · Baseline and up to 2 years
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.
Median Percentage of Cells From Biopsy and Surgery That Are Positive For Ki-67
Time frame · up to 2 years
The 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.
Record Participant Biomarker Results and Correlates of Response
Time frame · Up to 14+/- days
through 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
Eligibility
Inclusion Criteria: * Histologic confirmation of prostatic adenocarcinoma by MSKCC inclusive of the following: * 3 or more positive biopsy cores or equivalent tumor specimen as confirmed by pathologist * At least 2 cores containing ≥3 mm of tissue with carcinoma or equivalent tumor specimen as confirmed by pathologist * A primary tumor Gleason score ≥ 7 * Adequate primary biopsy tissue or equivalent tumor specimen as confirmed by pathologist available for protocol required analysis (i.e. bladder or TURP specimen) * Planning to have or have had a radical prostatectomy (RP) at MSKCC * Candidates may have a history of deep vein thrombosis, pulmonary embolism, and/or cerebrovascular accident, or require concomitant systemic anticoagulation, if otherwise deemed to be suitable for RP * Karnofsky performance status \>70% (Appendix A) * Sexually active fertile subjects, and their partners, must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 3 months after the dose of study drug(s) for Cohorts 1 , 2 and 4, and for 3 months after the surgery for Cohort 3 * For cohorts 1,2 and 4 only:, non-castrate testosterone level (\>100 ng/dL) * For cohort 3 only:, 1-6 months of androgen deprivation therapy (gonadotropin hormone releasing analogs with or without an anti-androgen) prior to prostatectomy with a castrate testosterone level of \<50 ng/dL within 1 month prior to prostatectomy. Exclusion Criteria: * Histologic variants in the primary tumor (histologic variants other than adenocarcinoma) * Current or prior chemotherapy * The use of the 5-alpha-reductase inhibitor dutasteride must be discontinued within 4 weeks of degarelix injection for Cohort 1, 2 and 4, and within 4 weeks of surgery for Cohort 3. * Saw palmetto administered with the intent to treat the patient's malignancy within 1 week of degarelix injection for Cohorts 1, 2 and 4, and for within 1 week of surgery for Cohort 3 * Current or prior radiation therapy to the prostate * Active infection or intercurrent illness * Concomitant therapy with any other experimental drug * For cohorts 1, 2 and 4 only:, current or prior hormonal therapy (e.g., gonadotropin hormone releasing analogs, megestrol acetate, or antiandrogens) are exclusionary
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Publications
Related trials
Novartis · Metastatic Neuroendocrine Prostate Cancer
Phase 1
Active, not recruiting
31
2026-07
Mayo Clinic · Recurrent Castration-Sensitive Prostate Carcinoma · Recurrent Prostate Cancer
Phase 2
Recruiting
532
2026-07
M.D. Anderson Cancer Center · Prostate Cancer
Phase 1 / Phase 2
Recruiting
6
2026-07
NYU Langone Health · Intraprostatic Prostate Cancer
Not applicable
Recruiting
28
2026-07
Memorial Sloan Kettering Cancer Center · Metastatic Castration Sensitive Prostate Cancer
Phase 2
Completed
16
2026-07
Stanford University · Prostate Adenocarcinoma · Stage I Prostate Cancer
Not applicable
Completed
146
2026-07
University of Wisconsin, Madison · Prostate Cancer
Phase 1 / Phase 2
Active, not recruiting
57
2026-07
Washington University School of Medicine · Prostate Cancer · Cancer of the Prostate
Not applicable
Active, not recruiting
28
2026-07
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.