A Multicenter Randomised Phase II Study Comparing the Efficiency of a HT Concomitant With RT vs RT Alone in the Salvage of Patients With a Detectable PSA After Prostatectomy

UC-0160/1204

The purpose of this study is to select the best therapeutic strategy in studying the effectiveness of the association of a short duration hormonal therapy and radiotherapy compared with radiotherapy alone, in patients with a detectable PSA after radical prostatectomy.

2012-12-01

2022-03-01

2025-03-01

Active (not recruiting)

Early phase I

120

Inclusion Criteria: 1. Patient with localized prostate adenocarcinoma treated with radical prostatectomy (whatever the initial prognostic stage) 2. R0 or R1 3. pN0 or pNx 4. Post prostatectomy PSA ≥0.2 ng/mL measured between 1 month and 4 months after surgery and increasing to a second test performed between 1 et 8 months after the post prostatectomy dosage 5. PSA ≤2 ng/mL at moment of the randomisation 6. No clinical signs of progressive disease (bone scan or PET scan or abdominal and pelvic scan or MRI): N0, M0 7. Neutrophils ≥1500/mm³; platelet count ≥100 000/mm³ 8. Bilirubin ≤ upper limit of normal (ULN); alkaline phosphatase (ALP), aspartate aminotransferase (AST), and Alanine aminotransferase (ALT) ≤1.5 ULN 9. Creatinine \<140 µmol/L (or clearance \>60 mL/min) 10. Normal fasting glucose 11. Eastern Cooperative Oncology Group (ECOG) ≤1 12. Age \>18 years 13. Life expectancy ≥10 years 14. Patients with invasive cancer in complete response for more than five years are eligible 15. Patients who have received the information sheet and signed the informed consent form 16. Patients with a public or a private health insurance coverage Exclusion Criteria: 1. Prostate cancer histology other than adenocarcinoma 2. Patients pN1, N1 and M1 3. History of pelvic radiotherapy 4. Contraindication to pelvic irradiation (eg, scleroderma, chronic inflammatory bowel disease, etc.) 5. Testosterone ≤0.5 ng/mL 6. History of surgical castration 7. Previous treatment by hormonotherapy 8. Antineoplastic treatment in progress 9. History of another invasive cancer within 5 years before inclusion (with the exception of a basal cell skin carcinoma treated) 10. Known pituitary adenoma 11. Severe hypertension uncontrolled by appropriate treatment (160 mm Hg systolic and/or 90 mm Hg diastolic) 12. Patient with a corrected QT interval (using Fridericia correction) greater than 450 msec 13. Individual deprived of liberty or placed under the authority of a tutor 14. Unable to undergo medical monitoring test for geographical, social or psychological reasons 15. Known hypersensitivity to the treatment in test 16. Administration of an investigational therapeutic within 28 days prior to the screening visit or more if treatment is likely to influence the outcome of this

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2023-12-08