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

NCT ID: NCT01542021

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-24
• Study Completion Date: 2024-09-30

Brief 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.

Conditions

Prostate Cancer; Prostatic Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

degarelix injection

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

degarelix injection

Intervention Type: DRUG

Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.

treated 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.

Group Type: EXPERIMENTAL

androgen deprivation therapy

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

degarelix injection

Intervention Type: DRUG

Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.

Interventions

degarelix injection

Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy, depending on treatment arm.

Intervention Type: DRUG

degarelix injection

Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.

Intervention Type: DRUG

androgen deprivation therapy

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dana Rathkopf, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

References

Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.

Reference Type: DERIVED

PMID: 34350976 (View on PubMed)

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

11-182

Identifier Type: -

Identifier Source: org_study_id