Overview

This trial is active, not recruiting.

Conditions prostate cancer, prostatic adenocarcinoma
Treatments degarelix injection, androgen deprivation therapy
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator Ferring Pharmaceuticals
Start date February 2012
End date February 2017
Trial size 41 participants
Trial identifier NCT01542021, 11-182

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
(Experimental)
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.
(Experimental)
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
(Experimental)
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.

Primary Outcomes

Measure
To assess between the time to determine the time of the maximal change in prostate cancer cell proliferation (Ki-67) and apoptosis rates (cleaved caspase-3)
time frame: 2 years

Secondary Outcomes

Measure
To explore the association between PTEN status and maximal changes in prostate cancer proliferation and apoptosis rates in patients treated with androgen deprivation therapy
time frame: 2 years
To explore the association between PI3K pathway (pAKT and pS6) and prostate cancer proliferation and apoptosis rates after treatment with androgen deprivation therapy in relation to other markers of prostate cancer (ERG, AR and NCOA2).
time frame: 2 years
To discover novel biomarkers and correlates of response
time frame: 2 years

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title Establishing a Neo-Adjuvant Platform for Developing Targeted Agents: Androgen Deprivation Therapy Prior to Prostatectomy for Patients With Intermediate and High Risk Prostate Cancer
Principal investigator Dana Rathkopf, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.
Location data was received from the National Cancer Institute and was last updated in October 2016.