Biochemically-relapsing prostate adenocarcinoma following radical prostatectomy. MedDRA version: 14.1 Level: LLT Classification code 10001186 Term: Adenocarcinoma of prostate System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Zytiga
Pharmaceutical Form: Tablet
CAS Number: 154229-18-2
Other descriptive name: ABIRATERONE ACETATE
Concentration unit: m
Sponsors
UNICANCER
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed prostate adenocarcinoma 2. The patients should have undergone only surgery for localized prostate adenocarcinoma: pT2, pT3 or pT4 with bladder neck involvement 3. pN0: negative lymphadenectomy at the time of prostatectomy 4. At inclusion the patients should have no clinical signs of progressive disease and should be M0 (bone and pelvic scans). 5. = 18 years of age with life expectancy = 10 years 6. Performance Status (ECOG) = 1 7. PSA = 0.1 ng/ml after prostatectomy (dosage performed within 2 months after surgery) 8. PSA = 0.2 ng/ml et = 2 ng/ml at the time of inclusion 9. Elevation of PSA over three consecutive assays performed in the same laboratory, with a minimal interval of two months between assays, (PSA nadir level followed by two other progressive assays) 10. At least 6 months between surgery and biochemical relapse 11. Serum potassium = 3.5 mmol/L in the 72 hours before first dose of abiraterone acetate 12. Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. pN1: histologically-proven lymph node involvement at initial lymphadenectomy 2. Histology other than adenocarcinoma 3. Previous hormone therapy including prior therapy with ketoconazole or other CYP17 inhibitor(s) for prostate cancer. 4. Patients being treated within the last 14 days prior to inclusion with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A4 (Clarithromycin, Ketoconazole, Itraconazole, Voriconazole, Ritanovir, see appendix 11) or requiring those treatments during the study 5. Active or symptomatic viral hepatitis or chronic liver disease 6. Surgical or chemical castration 7. History of cancer, with the exception of basal cell carcinoma or any other cancer treated in the 5 years before inclusion and in complete remission. 8. Previous pelvic radiotherapy 9. Uncontrolled hypertension (defined as systolic BP = 140 mmHg or diastolic BP = 90 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy (see appendix 10 for mandatory BP measurement guidelines) 10. Severe and moderate hepatic impairment (Child-Pugh class B and C) 11. Patients with severe and/or uncontrolled medical disease which could compromise participation in the study, such as, but not limited to: 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 III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline 12. Known hypersensitivity to any of the study drugs or excipients. 13. Galactosemia, Glucose-galactose malabsorption or lactase deficiency 14. Patients with any psychological, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. 15. Individual deprived of liberty or placed under the authority of a tutor. 16. Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within a period of 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I: To determine the maximum tolerated dose (MTD) and the phase II recommended dose (P2RD) of abiraterone acetate plus prednisone combined with radiotherapy and LH-RH agonist treatment in patients with biochemical relapse from prostate cancer following surgery. Phase II: To determine the 3-year Biochemical Relapse-free survival ; Secondary Objective: Phase I and II: • To determine the overall safety (3 years) profile • To define the 3-year Overall survival • To define the 3-year Metastases-free survival • Time to achieve PSA nadir Ancillary research ; Primary end point(s): hase I part: The main objective is to determine the maximum tolerated dose (MTD) and the phase II recommended dose. Determination of the MTD is based on the occurrence of DLT (Dose Limiting toxicity) The DLT evaluation period lasts 11 weeks starting from the radiotherapy initiation. Toxicities are assessed weekly during the DLT evaluation period and at every visit through a clinical assessment, laboratory examinations and an ECG every 3 months. Toxicities are scored according National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Phase II part: The safety analysis for the phase II part will include those patients who received at least one dose of abiraterone and those treated in phase I treated at the dose carried forward in the phase II. Toxicities are assessed at every visit through a clinical assessment, laboratory examinations and an ECG every 3 months. Toxicities are scored according National | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): EXPLORATORY ASSESSMENT: Phase I and II: Testosterone and LH serum levels (all testosterone and LH assays must be done for each patient in the same laboratory) Number of circulating tumor cells (CTC). Phase II: Bone density. Quality of life is assessed using the QLQ-C30, PR25 and IIEF questionnaires | — |
Countries
France
Contacts
Public ContactKarine BUFFARD - Project Manager
UNICANCER
Outcome results
None listed