An open label, randomized, phase III study, evaluating the efficacy of a Combination of Apalutamide with Radiotherapy and LHRH Agonist in high-risk postprostatectomy biochemically relapsed prostate cancer patients.

Phase 1

• Conditions: High-risk biochemically-relapsed prostate adenocarcinoma following radical prostatectomy.; MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-000155-21-FR
• Lead Sponsor: ICANCER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-31
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 490

Inclusion Criteria

1. Patients must have signed a written informed consent form prior to any trial specific procedures
2. Age = 18 years old and = 80 years old
3. Histologically confirmed diagnosis of prostate adenocarcinoma treated primarily with radical prostatectomy
4. Pathologically proven to be lymph node negative by pelvic lymphadenectomy (N0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [Nx])
5. Tumor stage pT2, pT3 or pT4* (*only in case of bladder neck involvement)
6. Patients should have no clinical and radiological signs (18FCH-PET CT-scan or 68Ga-PSMA-PET) of metastatic disease. Patients with a local relapse detected on PET scan be randomized
7. ECOG performance status = 1
8. PSA = 0.1 ng/mL after radical prostatectomy (dosage performed within 3 months after surgery)
9. PSA = 0.2 ng/mL and = 2 ng/mL at the time of randomization with an elevation of PSA over three consecutive assays
10. At least 6 months between radical prostatectomy and biochemical relapse
11. High-risk features as defined by at least one of these characteristics: PSA at relapse > 0.5 ng/mL or Gleason score > 7 or tumor stage pT3b or resection margins R0 or PSA doubling time = 6 months
12. Adequate renal function: serum creatinine < 1.5 x upper limit of normal (ULN) or a calculated corrected creatinine clearance = 60 mL/min according to the Cockcroft-Gault formula, creatinemia < 2 ULN
13. Adequate hepatic function: total bilirubin = 1.5 x ULN (unless documented Gilbert’s syndrome), AST and ALT = 2.5 x ULN
14. Patients with female partners of reproductive potential should agree to use effective contraceptive method during treatement period and for 3 months after the last dose of apalutamide or for 6 months after the last fraction of radiotherapy
15. Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
16. Patients must be affiliated to the Social Security System
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 290

Exclusion Criteria

1. Histologically proven lymph nodes involvement at initial lymphadenectomy: pN1,pN2, pN3
2. Previous treatment with hormone therapy for prostate cancer
3. Histology other than adenocarcinoma
4. Surgical or chemical castration
5. Other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been cured for at least 5 years
6. Previous pelvic radiotherapy
7. History of Inflammatory bowel disease or any malabsorption syndrome or conditions that would interfere with enteral absorption
8. Uncontrolled hypertension (defined as systolic blood pressure (BP) = 140 mmHg or diastolic BP = 90 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
9. Clinically significant history of liver disease consistent with Child-Pugh class B or C
10. History of seizure or condition that may pre-dispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness = 1 year prior to randomization; brain arteriovenous malformation or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
11. Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
12. Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g pulmonary embolism, cerebrovascular accident including transient ischemic attacks) or clinically significant ventricular arrhythmias within 6 months prior to randomization
13. Known hypersensitivity to apalutamide or to any of its components
14. Galactosemia, Glucose-galactose malabsorption or lactase deficiency
15. Inability or willingness to swallow oral medication
16. Individual deprived of liberty or placed under the authority of a tutor
17. Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within the 30 days before inclusion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified