Androgen Deprivation Therapy Prior to Prostatectomy for Patients with Intermediate and High Risk Prostate Cancer
NCT01542021 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41
Last updated 2024-10-03
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
Interventions
- 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
Sponsors & Collaborators
-
Ferring Pharmaceuticals
collaborator INDUSTRY -
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Dana Rathkopf, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-02-24
- Primary Completion
- 2024-09-30
- Completion
- 2024-09-30
Countries
- United States
Study Locations
More Related Trials
-
Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer
NCT00738673 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Degarelix in Patients With Prostate Cancer
NCT00928434 ·Status: COMPLETED ·Phase: PHASE3
-
Open-Label, Randomised Parallel-Group Study
NCT00728533 ·Status: WITHDRAWN ·Phase: PHASE3
-
Degarelix Before Radical Prostatectomy
NCT01852864 ·Status: UNKNOWN ·Phase: EARLY_PHASE1
-
Therapy Pathways in the Treatment of Hormone Naïve Prostate Cancer Patients With and Without Comorbidities Treated With Degarelix or Luteinizing-Hormone-Releasing-Hormone (LHRH) Agonists.
NCT02234089 ·Status: COMPLETED
-
A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer
NCT00116779 ·Status: COMPLETED ·Phase: PHASE2
-
A Degarelix Trial in Patients With Prostate Cancer
NCT01242748 ·Status: TERMINATED ·Phase: PHASE3
-
Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients
NCT00245466 ·Status: TERMINATED ·Phase: PHASE2
-
The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer
NCT00819247 ·Status: COMPLETED ·Phase: PHASE2
-
A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer
NCT00116753 ·Status: COMPLETED ·Phase: PHASE2
-
Feasibility and Toxicity of Degarelix for Prostate Downsizing Prior to Permanent Seed Prostate Brachytherapy
NCT01446991 ·Status: COMPLETED ·Phase: PHASE2
-
Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
NCT00468286 ·Status: COMPLETED ·Phase: PHASE2
-
Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer
NCT00833248 ·Status: COMPLETED ·Phase: PHASE3
-
Degarelix Acetate Before and During Radiation Therapy in Treating Patients With Prostate Cancer
NCT01731912 ·Status: COMPLETED ·Phase: NA
-
A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy
NCT00451958 ·Status: COMPLETED ·Phase: PHASE3
-
Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery
NCT03070886 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Study of BMS986365 in Combination With Degarelix in People With Prostate Cancer
NCT07335796 ·Status: RECRUITING ·Phase: PHASE2
-
Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer
NCT02799706 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Study of Olaparib (± Degarelix) Given to Men With Intermediate/High Risk Prostate Cancer Before Prostatectomy
NCT02324998 ·Status: COMPLETED ·Phase: PHASE1
-
Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists
NCT01366053 ·Status: COMPLETED
-
Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
NCT00215657 ·Status: TERMINATED ·Phase: PHASE2
-
The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer
NCT00295750 ·Status: COMPLETED ·Phase: PHASE3
-
Non-fucosylated Anti-CTLA-4 (BMS-986218) + Degarelix Acetate vs. Degarelix Acetate Alone in Men With High-risk Localized Prostate Cancer
NCT04301414 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer
NCT00819156 ·Status: COMPLETED ·Phase: PHASE2
-
Neoadjuvant Degarelix With or Without Apalutamide (ARN-509) Followed by Radical Prostatectomy
NCT03080116 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2