Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01786265 |
Recruitment Status :
Active, not recruiting
First Posted : February 7, 2013
Last Update Posted : December 7, 2022
|
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | February 5, 2013 | ||||
First Posted Date ICMJE | February 7, 2013 | ||||
Last Update Posted Date | December 7, 2022 | ||||
Actual Study Start Date ICMJE | February 5, 2013 | ||||
Estimated Primary Completion Date | February 1, 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Prostate-specific antigen (PSA) free survival (PSA < 0.1 ng/ml) [ Time Frame: At 12 months after treatment ] | ||||
Original Primary Outcome Measures ICMJE |
Prostate Specific Antigen (PSA) Free Survival [ Time Frame: 12 months ] Primary endpoint is PSA free survival (PSA < 0.1 ng/ml) at 12 months after treatment. Estimation made whether finite maximal androgen ablation (8 month) as compared to LHRH Alone will improve one year post-treatment PSA free survival by 20%.
|
||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer | ||||
Official Title ICMJE | A Randomized Study of Finite Androgen Ablation vs. Finite Androgen Ablation in Combination With Abiraterone Acetate and Prednisone in Patients With Prostate Cancer Who Have PSA Progression After Prostatectomy and/or Radiotherapy | ||||
Brief Summary | This phase II trial studies how well finite androgen ablation with or without abiraterone acetate and prednisone work in treating patients with prostate cancer that has come back. Androgen can cause the growth of prostate cancer cells. Hormone therapy, such as finite androgen ablation, using leuprolide acetate, goserelin acetate, degarelix, bicalutamide, flutamide, and nilutamide may fight prostate cancer by lowering the amount of androgen the body makes. Abiraterone acetate may help to decrease the production of testosterone, and prednisone may help lower or prevent some side effects. It is not yet known whether giving acetate, goserelin acetate, degarelix, bicalutamide, flutamide, and nilutamide with or without abiraterone acetate and prednisone may work better in treating patients with prostate cancer. | ||||
Detailed Description | PRIMARY OBJECTIVE: I. To evaluate whether finite maximal androgen ablation (8 month), as compared to luteinizing-hormone-releasing hormone (LHRH) alone, will improve one-year post-treatment prostate specific antigen (PSA)-free survival by 20%. SECONDARY OBJECTIVES: I. To determine testosterone recovery difference between the two groups. II. Calculate the PSA-free survival following testosterone recovery. III. To determine in the steroid biosynthesis metabolome, in the blood and bone marrow of patients at baseline, maximum response (eight months therapy) and upon PSA progression, evidence of minimal residual cancer (MD Anderson Cancer Center [MDACC] main campus patients only). IV. To apply technologies in development able to detect presence of cancer cells ("minimal residual disease") at a clinical study milestone (baseline, completion of therapy and upon PSA progression). EXPLORATORY OBJECTIVE: I. To explore in archival tissue samples for a candidate predictive signature of outcome applying technologies for interrogation of protein deoxyribonucleic acid (dna) and ribonucleic acid (rna) levels of molecular markers / pathways of interest. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive either leuprolide acetate via injection every month or every 4 months, goserelin acetate via injection every month, or degarelix via injection every month for 8 months. Patients also receive bicalutamide orally (PO) once daily (QD), flutamide PO three times daily (TID), or nilutamide PO QD. Patients may crossover to Arm B with disease progression after 8 months. ARM B: Patients receive leuprolide acetate, goserelin acetate, degarelix, bicalutamide, flutamide, or nilutamide as in Arm A. Patients also receive abiraterone acetate PO daily for 8 months and prednisone daily. Patients may crossover to Arm A with disease progression after 8 months. After completion of study treatment, patients are followed up every 3 and 6 months. |
||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
Condition ICMJE |
|
||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
310 | ||||
Original Estimated Enrollment ICMJE |
200 | ||||
Estimated Study Completion Date ICMJE | February 1, 2025 | ||||
Estimated Primary Completion Date | February 1, 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01786265 | ||||
Other Study ID Numbers ICMJE | 2012-0993 NCI-2018-01856 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2012-0993 ( Other Identifier: M D Anderson Cancer Center ) |
||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | M.D. Anderson Cancer Center | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
PRS Account | M.D. Anderson Cancer Center | ||||
Verification Date | November 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |