3-arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients With Prostate Cancer With a Rising PSA or a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy
|ClinicalTrials.gov Identifier: NCT01751451|
Recruitment Status : Active, not recruiting
First Posted : December 18, 2012
Last Update Posted : April 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Abiraterone acetate Drug: Abiraterone acetate plus degarelix Drug: Degarelix||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Randomized, 3-arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients With Prostate Cancer With a Rising PSA or a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: Abiraterone acetate
Drug: Abiraterone acetate
Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food.
Experimental: Abiraterone acetate and Degarelix
Abiraterone acetate 1000 mg daily x 8 months
Drug: Abiraterone acetate plus degarelix
Patients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter.
• Degarelix subcutaneous depot injection q 1 month x 8 months
Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter.
- progression-free survival (PFS) [ Time Frame: 18 months ]defined as an undetectable PSA (using a routine non-ultrasensitive PSA assay) with non-castrate level of testosterone (>150 ng/dL) at 18 months from the time of treatment initiation (PSA0).
- Soft tissue complete response [ Time Frame: 1 year ]In addition to an undetectable PSA, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (Complete Response per RECIST) in order to meet the criteria for PFS. Outcome in subjects who develop radiographically evident metastatic disease while on study will be considered treatment failures independent of their respective PSA values.
- PSA response rate [ Time Frame: 8 months ]The percentage of patients with a non-castrate level of testosterone (>150 ng/dL) and an undetectable PSA at 8 months from PSA0 will be measured.
- overall quality of life [ Time Frame: 1 year ]with particular attention to libido, potency, anxiety, depression, hot flashes, and fatigue. Effects of each arm on health-related quality of life will be assessed via PRO Survey (Appendix C) completed on paper by the patient at the following study visits: Up to 30 Days Prior to Randomization, each Day 1 of Treatment Cycle, End of Treatment, and each Post-Treatment Follow-up.Effects of each arm on quality of life,
- non-hematologic adverse events [ Time Frame: 1 year ]Safety will be evaluated according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, physical examinations and clinical laboratory tests throughout the conduct of the study.
- Testosterone and luteinizing hormone (LH) recovery rates [ Time Frame: 8 -10 months ]Testosterone and LH recovery rates will be measured at 8 months from the start of randomization and at each month of the 10 month follow up period.
- Correlative tissue analysis [ Time Frame: 1 year ]Tissue samples will be utilized for morphologic assessment, percent tumor involvement (if applicable), and immunohistochemistry. The immunohistochemical markers assessed may be AR, PTEN, PSMA, fatty acid synthase (FASN), phospho-AMPK, phospho-ACC, phospho-S6 kinase, phospho-Akt for the assessment of the AMPK, lipid synthesis, mTOR pathways, and immunological markers.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751451
|United States, Illinois|
|Northwestern University, Feinberg School of Medicine|
|Chicago, Illinois, United States, 60611|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21287|
|United States, Michigan|
|Karmanos Cancer Institute, Wayne State University|
|Detroit, Michigan, United States, 48201|
|United States, Nebraska|
|Urology Cancer Center and GU Research Network|
|Omaha, Nebraska, United States, 68130|
|United States, New Jersey|
|Memoral Sloan Kettering Cancer Center|
|Basking Ridge, New Jersey, United States|
|Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|United States, New York|
|Memorial Sloan Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering West Harrison|
|Harrison, New York, United States, 10604|
|NorthShore University Health System|
|Long Island City, New York, United States|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Weill Cornell Medical Center|
|New York, New York, United States|
|Memorial Sloan Kettering at Mercy Medical Center|
|Rockville Centre, New York, United States|
|Memoral Sloan Kettering Cancer Center at Phelps|
|Sleepy Hollow, New York, United States, 10591|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27514|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27701|
|United States, Oregon|
|Oregon Health & Science University Knight Cancer Institute|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Howard I Scher, MD||Memorial Sloan Kettering Cancer Center|