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A clinical study evaluating the benefits of apalutamide, a novel drug targeting prostate cancer growth, in combination with radiotherapy and hormonetherapy in prostate cancer patients in whom PSA increases following surgery
EU CTIS ID: 2024-514829-36-00
What this study is testing
To evaluate the clinical benefit of adding the androgen receptor competitive inhibitor apalutamide in combination with a Luteinizing Hormone Releasing Hormone (LHRH) agonist concomitantly to salvage radiotherapy (SRT) after biochemical progression following radical prostatectomy in patients with high-risk prostate adenocarcinoma. The clinical benefit will be evaluated using the progression-free survival (PFS) rate at 5 years.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients must have signed a written informed consent form prior to any trial specific procedures
- 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
- Adequate hepatic function: total bilirubin ≤ 1.5 x ULN (unless documented Gilbert’s syndrome), AST and ALT ≤ 2.5 x ULN
- Patients with QTc prolongation < 500 ms*, inclusion should considered after close benefit/risk assessment and cardiologist advice *In patients with a history or risk factors for QT prolongation, and in patients receiving concomitant medicines that may prolong the QT interval, a cardiologist should assess the benefit / risk balance taking into account the potential risk of torsade de pointes before initiating treatment with apalutamide
- 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
- Patients must be affiliated to the Social Security System
You likely can't join if
- Previous treatment with hormone therapy for prostate cancer
- More than 5 (>5) pelvic lymph node relapses
- Paraaortic, thoracic or supaclavicular nodal relapse (M1a)
- History of Inflammatory bowel disease or any malabsorption syndrome or conditions that would interfere with enteral absorption
- 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
- Certain risk factors for abnormal heart rhythmas/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
See the full eligibility criteria
Who can join
- Patients must have signed a written informed consent form prior to any trial specific procedures
- 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
- Adequate hepatic function: total bilirubin ≤ 1.5 x ULN (unless documented Gilbert’s syndrome), AST and ALT ≤ 2.5 x ULN
- Patients with QTc prolongation < 500 ms*, inclusion should considered after close benefit/risk assessment and cardiologist advice *In patients with a history or risk factors for QT prolongation, and in patients receiving concomitant medicines that may prolong the QT interval, a cardiologist should assess the benefit / risk balance taking into account the potential risk of torsade de pointes before initiating treatment with apalutamide
- 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
- Patients must be affiliated to the Social Security System
- Age ≥ 18 years old and ≤ 80 years old
- Histologically confirmed diagnosis of prostate adenocarcinoma treated primarily with radical prostatectomy
- Tumor stage pT2, pT3 or pT4* (*only in case of bladder neck involvement)
- 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
- ECOG performance status ≤ 1
- PSA ≥ 0.2 ng/mL at the time of randomization with an elevation of PSA over three consecutive PSA increases over a 1-month interval minimum
- At least 3 months between radical prostatectomy and randomization
- 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)
What rules you out
- Previous treatment with hormone therapy for prostate cancer
- More than 5 (>5) pelvic lymph node relapses
- Paraaortic, thoracic or supaclavicular nodal relapse (M1a)
- History of Inflammatory bowel disease or any malabsorption syndrome or conditions that would interfere with enteral absorption
- 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
- Certain risk factors for abnormal heart rhythmas/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
- Medications known to prolong QTc
- Known hypersensitivity to apalutamide or to any of its components
- Galactosemia, Glucose-galactose malabsorption or lactase deficiency
- Inability or willingness to swallow oral medication
- Individual deprived of liberty or placed under the authority of a tutor
- Uncontrolled hypertension (defined as systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 100 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
- Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within the 30 days before inclusion
- 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)
- Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
- Clinically significant history of liver disease consistent with Child-Pugh class B or C
- Histology other than adenocarcinoma
- Surgical or chemical castration
- 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
- Previous pelvic radiotherapy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.