Know Cancer

forgot password

Establishing a Neo-Adjuvant Platform for Developing Targeted Agents: Degarelix Prior to Prostatectomy for Patients With Intermediate and High Risk Prostate Cancer

18 Years
Open (Enrolling)
Prostate Cancer, Prostatic Adenocarcinoma

Thank you

Trial Information

Establishing a Neo-Adjuvant Platform for Developing Targeted Agents: Degarelix Prior to Prostatectomy for Patients With Intermediate and High Risk Prostate Cancer

Inclusion Criteria:

- Histologic confirmation of prostatic adenocarcinoma by MSKCC inclusive of the

- 3 or more positive biopsy cores

- At least 2 cores containing ≥3 mm of tissue with carcinoma

- A primary tumor Gleason score ≥ 7

- Adequate primary biopsy tissue available for protocol required analysis

- Non-castrate testosterone level (>150 ng/dL)

- Planning to have 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

- Normal organ function with acceptable initial laboratory values:

- WBC >3000/μL

- Platelets >150,000/μL

- Creatinine <2 mg/dL

- Bilirubin <1.5 X ULN (institutional upper limits of normal)


- 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)

Exclusion Criteria:

- Histologic variants in the primary tumor (histologic variants other than

- Current or prior chemotherapy

- Current or prior hormonal therapy (e.g., gonadotropin hormone releasing analogs,
megestrol acetate, or antiandrogens) are exclusionary. The use of 5-alpha-reductase
inhibitors or steroids must be discontinued within 4 weeks of degarelix injection

- Herbal medications administered with the intent to treat the patient's malignancy
within 4 weeks of degarelix injection

- Current or prior radiation therapy to the prostate

- Active infection or intercurrent illness

- Concomitant therapy with any other experimental drug

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To choose between two time intervals to determine the time of the maximal change in prostate cancer cell proliferation (Ki-67) and apoptosis rates (cleaved caspase-3) following treatment with degarelix.

Outcome Description:

The primary endpoint is the change in the rate of proliferation (Ki-67) and the rate of apoptosis (cleaved caspase-3), 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. Cleaved caspase-3 has been shown to be a reliable marker of apoptosis and correlate with results from other apoptosis markers such as cleaved PARP-1 and TUNEL assay.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Dana Rathkopf, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2012

Completion Date:

February 2014

Related Keywords:

  • Prostate Cancer
  • Prostatic Adenocarcinoma
  • prostate
  • Degarelix
  • injections
  • radical prostatectomy
  • 11-182
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms



Memorial Sloan Kettering Cancer Center New York, New York  10021