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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 (CARLHA)

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ClinicalTrials.gov Identifier: NCT01780220
Recruitment Status : Unknown
Verified January 2013 by UNICANCER.
Recruitment status was:  Recruiting
First Posted : January 30, 2013
Last Update Posted : January 30, 2013
Information provided by (Responsible Party):

Brief Summary:

As there is no prospective data on the combination of abiraterone and salvage radiotherapy, the aim of this study is to further evaluate the safety profile of abiraterone acetate plus prednisone in patients with prostate cancer who are biochemically relapsing after surgery and undergo salvage radiotherapy with 6-months LH-RH agonist.

The investigators hypothesize that the toxicity profile of both treatments should not potentiate each other. This study will also provide preliminary data on the efficacy of this combination.

Condition or disease Intervention/treatment Phase
Biochemically-relapsing Prostate Adenocarcinoma Following Radical Prostatectomy Drug: Abiraterone Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2012
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
U.S. FDA Resources

Arm Intervention/treatment
Experimental: abiraterone
Abiraterone acetate (three dose levels in phase I) + prednisone (10mg/day)+LHRH + Radiotherapy
Drug: Abiraterone
Abiraterone acetate 1000mg/day + prednisone alone for one month before initiating the sequence of radiotherapy

Primary Outcome Measures :
  1. to determine the maximum tolerated dose and the phase II recommended dose of abiraterone acetate treatment plus prednisone and LH-RH agonist combined with prostate radiotherapy [ Time Frame: within 11 weeks after Radiotherapy initiation ]

Secondary Outcome Measures :
  1. To evaluate the 3-year biochemical relapse-free survival [ Time Frame: 3 years ]

Other Outcome Measures:
  1. overall safety profile [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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 < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min
  13. Liver function:

    Serum bilirubin < 1.5 x ULN (except for patients with documented Gilbert's disease) AST and ALT < 2.5 x ULN

  14. Patients must be affiliated to a Social Security System.
  15. Patient information and written informed consent form signed for both principal and additional research
  16. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01780220

Contact: karine buffard, Phar D k-buffard@unicancer.fr
Contact: Céline Mahier c-mahier@unicancer.fr

Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Christian CARRIE, Pr         
Principal Investigator: Christian CARRIE, Pr         
Institut de Cancérologie de l'ouest/René Gauducheau Recruiting
Saint Herblain, Nantes, France, 44805
Contact: Stéphane Supiot, MD, PhD    0240679933    stephane.supiot@ico.unicancer.fr   
Principal Investigator: stephane Supiot, MD, PhD         
Sponsors and Collaborators

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT01780220     History of Changes
Other Study ID Numbers: GEP12-UC-0101/1104
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: January 30, 2013
Last Verified: January 2013

Keywords provided by UNICANCER:
prostate adenocarcinoma

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Abiraterone Acetate
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 Enzyme Inhibitors