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. - GEP12-CARLHA

ICANCER0 sites43 target enrollmentSeptember 17, 2012

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Biochemically-relapsing prostate adenocarcinoma following radical prostatectomy.
Sponsor: ICANCER
Enrollment: 43
Status: Active, Not Recruiting
Last Updated: 7 years ago

No summary available.

Registry

who.int

Start Date

September 17, 2012

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

ICANCER

•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

•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)