Last updated on January 2013

Safety and Efficacy of Radiotherapy Combined With a 6-month LH-RH Agonist and Abiraterone Hormone Therapy Treatment in Biochemically-relapsing Prostate Cancer Following Surgery

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Biochemically-relapsing Prostate Adenocarcinoma Following Radical Prostatectomy
  • Age: Between 18 - 100 Years
  • Gender: Male
  • Other:
    Histologically confirmed prostate adenocarcinoma
    The patients should have undergone only surgery for localized prostate
    adenocarcinoma: pT2, pT3 or pT4 with bladder neck involvement
    pN0: negative lymphadenectomy at the time of prostatectomy
    At inclusion the patients should have no clinical signs of progressive disease and
    hould be M0 (bone and pelvic scans).
    ≥ 18 years of age with life expectancy ≥ 10 years
    Performance Status (ECOG) ≤ 1
    PSA ≤ 0.1 ng/ml after prostatectomy (dosage performed within 2 months after surgery)
    PSA ≥ 0.2 ng/ml et ≤ 2 ng/ml at the time of inclusion
    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)
    At least 6 months between surgery and biochemical relapse
    Serum potassium ≥ 3.5 mmol/L in the 72 hours before first dose of abiraterone acetate
    Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min
    Liver function:
    Serum bilirubin < 1.5 x ULN (except for patients with documented Gilbert's disease)
    AST and ALT < 2.5 x ULN
    Patients must be affiliated to a Social Security System.
    Patient information and written informed consent form signed for both principal and
    additional research
    Patients must be willing and able to comply with scheduled visits, treatment plan,
    laboratory tests and other study procedures

You may not be eligible for this study if the following are true:

  • pN1: histologically-proven lymph node involvement at initial lymphadenectomy
    Histology other than adenocarcinoma
    Previous hormone therapy including prior therapy with ketoconazole or other CYP17
    inhibitor(s) for prostate cancer.
    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
    Active or symptomatic viral hepatitis or chronic liver disease
    Surgical or chemical castration
    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.
    Previous pelvic radiotherapy
    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
    Severe and moderate hepatic impairment (Child-Pugh class B and C)
    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
    Known hypersensitivity to any of the study drugs or excipients.
    Galactosemia, Glucose-galactose malabsorption or lactase deficiency
    Patients with any psychological, sociological or geographical condition potentially
    hampering compliance with the study protocol and follow-up schedule; those conditions
    hould be discussed with the patient before registration in the trial.
    Individual deprived of liberty or placed under the authority of a tutor.
    Patients already included in another therapeutic trial with an experimental drug or
    having been given an experimental drug within a period of 30 days.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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