Finite Androgen Ablation vs. Finite Androgen Ablation in Combination With Abiraterone Acetate and Prednisone
This trial is active, not recruiting.
|Treatments||lupron, zoladex, degarelix, abiraterone acetate, prednisone|
|Sponsor||M.D. Anderson Cancer Center|
|Collaborator||Janssen Services, LLC|
|Start date||February 2013|
|End date||February 2019|
|Trial size||200 participants|
|Trial identifier||NCT01786265, 2012-0993, NCI-2013-00460|
The goal of this clinical research study is to learn if treatment with hormone therapy in combination with abiraterone acetate and prednisone for 8 months controls the disease better than treatment with standard hormone therapy alone.
Abiraterone acetate is designed to decrease the production of testosterone (male sex hormones), which plays a role in causing prostate cancer to grow.
Prednisone is commonly used to treat prostate cancer and is given along with abiraterone acetate treatment to help lower or prevent some side effects.
|Intervention model||crossover assignment|
Prostate Specific Antigen (PSA) Free Survival
time frame: 12 months
Male participants at least 18 years old.
Inclusion Criteria: 1. Have signed an informed consent document indicating that the subjects understands the purpose of and procedures required for the study and are willing to participate in the study 2. Written Authorization for Use and Release of Health and Research Study Information has been obtained 3. Be willing/able to adhere to the prohibitions and restrictions specified in this protocol 4. Male patients >/= 18 years of age 5. Life expectancy >/= 12 months 6. ECOG Performance Status (PS) = 2 7. Histologically documented diagnosis of adenocarcinoma of the prostate (PCa) with no histologic variants 8. Prostate cancer recurrence after definitive local therapy (radical prostatectomy and/or radiation therapy) as evidenced by rising serum PSA, without evidence of metastases by bone scan or CT scan. a) After radiation: A rising PSA taken to indicate recurrent prostate cancer in patients with previous definitive external beam radiotherapy will be defined as PSA of 1.0, b) After Radical Prostatectomy: A rising PSA taken to indicate recurrent prostate cancer in patients with previous radical prostatectomy will be defined by the criteria of the American Urological Association as any PSA measurement of 0.2, with a subsequent measurement >0.2 ng/mL 9. Patients who have received androgen ablative therapy for less than 8 weeks immediately prior to initiation of study drug are eligible provided they had only PSA evidence of progression (as defined above) with no visible metastases by CT-scan and bone scan (within 6 weeks) prior to starting androgen ablation 10. Patients must have WBC >/= 3.5 x 10^9/L, ANC >/= 1.5 x 10^9/L, platelets >/= 100 x 10^9/L, Hb >/= 9.0 g/dL); total bilirubin = 1.5 x ULN, AST and ALT = 1.5 x the upper limit of normal; serum potassium of >/= 3.5 mEq/L, serum albumin of >/= 3.0 g/dL, serum creatinine = 1.5 x ULN 11. Patients must have recovered from prior treatment regimens, e.g. surgery, radiation 12. A patient who is sexually active and their partner must agree and use two reliable barrier forms of contraception (for example, condoms and diaphragm), from first day of study drug administration until for 1 week after last dose of abiraterone acetate, unless partner is post-menopausal 13. Able to swallow the study drug whole as a tablet 14. Willing to take abiraterone acetate on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken Exclusion Criteria: 1. Patients who have received prior hormonal therapy are excluded from the trial, except for: patients who have received up to 6 months of hormonal therapy as neoadjuvant therapy before radical prostatectomy or while on radiation therapy, as long as more than 1 year has elapsed between discontinuation of the neoadjuvant hormonal therapy and initiation of hormonal treatment for relapsing disease 2. Any known metastases 3. Prolonged QTc interval on pre-entry electrocardiogram (>/= 450 msec) 4. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline 5. Significant co-morbidity that could affect the safety or evaluability of participants as assessed by the treating physician and or principal investigator 6. Prior therapy with strontium-89, samarium, rhenium-186 etidronate, chemotherapy or androgen biosynthesis inhibitors for prostate cancer is not allowed. Previous immunologic, homeopathic, natural, or alternative medicine therapies are acceptable provided treatment ended greater than 28 days prior to initiation of study drug 7. Patients who, in the opinion of the investigator, are unable to comply with the requirements of the study protocol are not eligible 8. Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated 9. Active or symptomatic viral hepatitis 10. History of pituitary or adrenal dysfunction 11. Administration of an investigational therapeutic drug within 30 Days of Cycle 1 Day 1 12. Have known allergies, hypersensitivity, or intolerance to abiraterone acetate or prednisone or their excipients 13. Have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents 14. Have a pre-existing condition that warrants long-term corticosteroid use in excess of study dose
|Official title||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|
|Principal investigator||Eleni Efstathiou, MD, PHD|
|Description||Study Groups and Study Drug Administration: If you are found to be eligible to take part in this study, you will be randomly assigned (like the flip of a coin) to 1 of 2 groups. You will have an equal chance of being assigned to each group. If you are in Group 1, you will receive standard of care hormonal therapy. The study doctor will decide what hormone therapy you will receive and will explain when and how you should take the hormone therapy and any risks. If you are in Group 2, you will also receive standard of care hormone therapy. In addition, you will take 4 abiraterone acetate tablets by mouth each day at least 2 hours before a meal and 1 hour after a meal. You will also take prednisone every day. About every 28-days is considered a "cycle." You should return all unused study drug and/or empty pill bottles at the end of each cycle. Study Visits for Group 1: On Day 1 of Cycles 1, 5, 9 and every odd cycle after that: - You will have a physical exam, including measurement of your weight and vital signs. - You will be asked about any side effects you may have had and any drugs or treatments you may be receiving. - Blood (about 2 tablespoons) will be drawn for routine tests, to check your liver function and your PSA and testosterone levels. Before the Cycle 5 blood draw only, you must fast overnight and in the morning for at least 8 hours before your visit. On Day 1 of Cycles 2, 3, 4, 6, 7, and 8, blood (about 2 tablespoons) will be drawn for routine tests, to check your liver function and your PSA levels. On Cycles 3 and 7, this blood will also be used to check your testosterone levels. These tests may be done at a local facility and results faxed to MD Anderson. Study Visits for Group 2: Every 2 weeks (for the first 12 weeks), blood (about 1-2 tablespoons) will be drawn to test your liver function. This may be done at a local facility and results faxed to MD Anderson. On Day 1 of Odd Cycles (1, 3, 5, and so on): - You will have a physical exam, including measurement of your weight and vital signs. - Your performance status will be recorded. - You will be asked about any side effects you may have had and any drugs or treatments you may be receiving. - Blood (about 2 tablespoons) will be drawn for routine tests, to check your liver function and your PSA and testosterone levels. Before the Cycle 5 blood draw only, you must fast overnight and in the morning for at least 8 hours before your visit. On Day 1 of Even Cycles (2, 4, 6, and so on): - You will have a physical exam, including measurement of your vital signs. - Your performance status will be recorded. - You will be asked about any side effects you may have had and any drugs or treatments you may be receiving. - Blood (about 2 tablespoons) will be drawn for routine tests, to check your liver function and your PSA levels. These study visits may be done at a local physician's office and results faxed to MD Anderson. Length of Study: You may receive the study drugs for up to 8 cycles. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your participation on the study will be over after the follow-up visits. End of Treatment Visit: When you are no longer taking the study drugs: - You will have a physical exam, including measurement of your weight and vital signs. - Your performance status will be recorded. - You will be asked about any side effects you may have had and any drugs or treatments you may be receiving. - Blood (about 3-4 tablespoons) will be drawn for routine tests, to check your liver function, and to check your PSA and your testosterone level. You must fast overnight and in the morning for at least 8 hours before your visit. - You will have a bone scan to check the status of the disease - You will have a CT scans to check the status of the disease. Follow-Up: Every 3 months, blood (about 1 teaspoon) will be drawn to test your PSA and testosterone levels. This may be done at your local local facility and the results faxed to MD Anderson. Every 6 months: - You will have a physical exam, including measurement of your weight and vital signs. - Your performance status will be recorded. - Blood (about 3 tablespoons) will be drawn for routine tests, to check your liver function, your PSA level and your testosterone level. The follow-up visits will continue as long as the disease is stable. Crossover Study Phase: If the disease gets worse while you are on study, you will be eligible for the extension phase. If you received hormone therapy alone, you will be treated with the combination of hormones and abiraterone acetate plus prednisone for 8 months. If you received the combination therapy, you will receive hormone therapy alone. If you crossover to the other treatment group on this study, the schedule for visits in the extension study will be identical to the schedule described above. This is an investigational study. Abiraterone acetate is FDA approved in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel. Prednisone is FDA approved and commercially available as a corticosteroid. The use of hormone therapy in combination with abiraterone and prednisone in patients with prostate cancer is investigational. Up to 310 patients will take part in this multicenter study. Up to 310 patients will be enrolled at MD Anderson.|
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