Combined Apalutamide, Radiotherapy, and LHRH Agonist in Prostate Cancer Patients After Prostatectomy

Launched by UNICANCER · Nov 26, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment that combines a medication called apalutamide with radiation therapy and hormone therapy in men with prostate cancer who have had surgery to remove their prostate. The aim is to see if this combination works better than radiation and hormone therapy alone for patients whose cancer has returned after surgery. This study is currently looking for male participants aged 18 to 80 who have been diagnosed with prostate cancer and have specific characteristics indicating their cancer is at high risk of recurring.

To be eligible, participants must have had surgery for their prostate cancer, and their cancer must be confirmed to have a specific stage and rising PSA levels, which is a marker for prostate cancer. The trial expects participants to undergo treatment and attend regular check-ups. It's important to note that certain health conditions or previous treatments might prevent someone from joining the study. If you're interested, you can talk to your doctor to see if this trial might be a good option for you.

Gender

MALE

Eligibility criteria

• 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. Tumor stage pT2, pT3 or pT4\* (\*only in case of bladder neck involvement)
• • 5. Patients should have no clinical and radiological signs (18FCH-PET CT-scan or 68Ga-PSMA-PET CT-scan) of metastatic disease. Patients with a local relapse or pelvic nodal relapse (N1) detected on PET CT-scan can be randomized
• • 6. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
• • 7. PSA ≥0.2 ng/mL at the time of randomization with an elevation of PSA over three consecutive assays. PSA increases over a 1-month interval minimum
• • 8. At least 3 months between radical prostatectomy and randomization.
• • 9. 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 or pelvic lymph node relapse (N1, ≤5 lymph nodes)
• • 10. 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
• • 11. Adequate hepatic function: total bilirubin ≤1.5 x ULN (unless documented Gilbert's syndrome), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN
• • 12. Patients with QTc prolongation \<500 ms, inclusion should considered after close benefit/risk assessment and cardiologist advice
• • 13. 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
• • 14. Patients must be affiliated to the Social Security System
• Exclusion Criteria:
• • 1. Previous treatment with hormone therapy for prostate cancer
• • 2. Histology other than adenocarcinoma
• • 3. Surgical or chemical castration
• • 4. 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
• • 5. Previous pelvic radiotherapy
• • 6. More than 5 (\>5) pelvic lymph node relapses
• • 7. Paraaortic, thoracic or supaclavicular nodal relapse (M1a)
• • 8. History of Inflammatory bowel disease or any malabsorption syndrome or conditions that would interfere with enteral absorption
• • 9. 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
• • 10. Clinically significant history of liver disease consistent with Child-Pugh class B or C
• • 11. 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)
• • 12. Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
• • 13. 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
• • 14. Certain risk factors for abnormal heart rhythms/QT prolongation: torsade de pointes ventricular arrhythmias (e.g, heart failure, hypokalemia, or a family history of a long QT syndrome), a QT or corrected QT (QTc) interval \>500 ms at baseline
• • 15. Medications known to prolong QTc
• • 16. Known hypersensitivity to apalutamide or to any of its components
• • 17. Galactosemia, Glucose-galactose malabsorption or lactase deficiency
• • 18. Inability or willingness to swallow oral medication
• • 19. Individual deprived of liberty or placed under the authority of a tutor
• • 20. Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within the 30 days before inclusion