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)

This study is currently recruiting participants.
Verified January 2013 by UNICANCER
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT01780220
First received: January 29, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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 Intervention Phase
Biochemically-relapsing Prostate Adenocarcinoma Following Radical Prostatectomy
Drug: Abiraterone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the 3-year biochemical relapse-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • overall safety profile [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 43
Study Start Date: December 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 < 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780220

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

Locations
France
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
UNICANCER
  More Information

No publications provided

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT01780220     History of Changes
Other Study ID Numbers: GEP12-UC-0101/1104
Study First Received: January 29, 2013
Last Updated: January 29, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament

Keywords provided by UNICANCER:
abiraterone
biochemically-relapsing
prostate adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014