Androgen Deprivation Therapy Prior to Prostatectomy for Patients with Intermediate and High Risk Prostate Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Prostatic Adenocarcinoma; Prostate Cancer

Treatments: Drug: degarelix injection; Drug: androgen deprivation therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01542021

11-182

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 4 patient groups

Untreated patients degarelix injection occur at days 4± 1

Experimental group

Description:

Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy

Treatment:

Drug: degarelix injection

Drug: degarelix injection

Untreated patients degarelix injection occur at days and 7± 1.

Experimental group

Description:

Treatment will consist of a single 240 mg injection of degarelix 7±1 day before radical prostatectomy

Treatment:

Drug: degarelix injection

Drug: degarelix injection

treated patients with androgen deprivation

Experimental group

Description:

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.

Treatment:

Drug: androgen deprivation therapy

Untreated patients degarelix injection occur at days 14±1

Experimental group

Description:

Treatment will consist of a single 240 mg injection of degarelix 14±1 day before radical prostatectomy

Treatment:

Drug: degarelix injection

Drug: degarelix injection