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A phase II, randomized, open-label study comparing salvage radiotherapy in combination with 6 months of androgen-deprivation therapy (ADT) with LHRH agonist or antagonist versus anti-androgen therapy (AAT) with apalutamide in patients with biochemical progression after radical prostatectomy
EU CTIS ID: 2024-512023-37-00
What this study is testing
To compare sexual function between the 2 treatment groups based on the EPIC-26 sexual domain at 9 months after start of hormonal treatment
- Therapeutic exploratory (Phase II)
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
- Male, > 18 years old
- Serum albumin ≥3.0 g/dL
- Serum creatinine <2.0 × upper limit of normal
- Serum potassium ≥3.5 mmol/L
- Serum total bilirubin ≤1.5 × ULN (note: in subjects with Gilbert’s syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject may be eligible)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN
You likely can't join if
- Patients with severe erectile dysfunction according to international index of erectile function (IIEF-5) questionnaire (score 1-7)
- Allergies, hypersensitivity or known intolerance to the study drugs or excipients.
- History of any of the following: Seizure or known condition that may pre-dispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to randomization, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
- History of any of the following: 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
- Current evidence of uncontrolled hypertension or gastrointestinal disorder affecting absorption
- Patients already included in another clinical trial involving an experimental drug.
See the full eligibility criteria
Who can join
- Male, > 18 years old
- Serum albumin ≥3.0 g/dL
- Serum creatinine <2.0 × upper limit of normal
- Serum potassium ≥3.5 mmol/L
- Serum total bilirubin ≤1.5 × ULN (note: in subjects with Gilbert’s syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject may be eligible)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN
- Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
- Patient agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
- Patients who have received the information sheet and signed the informed consent form
- Patients must be willing to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- ECOG 0-1
- Histologically confirmed adenocarcinoma of the prostate
- Previous radical prostatectomy (RP), pT2-3, pN0 or pNx
- PSA detectable with confirmed rise (at least 2 weeks apart) at least 8 weeks after RP
- Hormone-naive disease
- Patients amendable to take oral medication
- Hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
- Platelet count ≥100,000 x 109/µL independent of transfusion and/or growth factors within 3 months prior to randomization
What rules you out
- Patients with severe erectile dysfunction according to international index of erectile function (IIEF-5) questionnaire (score 1-7)
- Allergies, hypersensitivity or known intolerance to the study drugs or excipients.
- History of any of the following: Seizure or known condition that may pre-dispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to randomization, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
- History of any of the following: 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
- Current evidence of uncontrolled hypertension or gastrointestinal disorder affecting absorption
- Patients already included in another clinical trial involving an experimental drug.
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, 65+ years, 18-64 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.