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

Phase 1

• Conditions: Prostate cancer; MedDRA version: 20.0Level: LLTClassification code: 10007113Term: Cancer of prostate Class: 10029104; Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-512023-37-00
• Lead Sponsor: GasthuisZusters Antwerpen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-31
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 202

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

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