Current partner codePEPTIDESDE
NCT01542021·Not applicable·INTERVENTIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

41

Locations

1

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

degarelix injection

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

DRUG

degarelix injection

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

DRUG

androgen deprivation therapy

Timeline

From registration to results.

  1. First posted

    Mar 1, 2012

  2. Study start

    Feb 24, 2012

  3. Primary completion

    Sep 30, 2024

  4. Study completion

    Sep 30, 2024

  5. Results posted

    Jul 29, 2026

  6. Registry updated

    Jul 29, 2026

Outcomes

What the study measures.

Primary 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.

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
MALE
Healthy volunteers
No

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

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Related trials

More studies on Degarelix.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.