Apalutamide for Prostate cancer

Inclusion criteria

• {"criterion_text":"- Male, > 18 years old"}
• {"criterion_text":"- ECOG 0-1"}
• {"criterion_text":"- Histologically confirmed adenocarcinoma of the prostate"}
• {"criterion_text":"- Previous radical prostatectomy (RP), pT2-3, pN0 or pNx"}
• {"criterion_text":"- PSA detectable with confirmed rise (at least 2 weeks apart) at least 8 weeks after RP"}
• {"criterion_text":"- Hormone-naive disease"}
• {"criterion_text":"- Patients amendable to take oral medication"}
• {"criterion_text":"- Hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization"}
• {"criterion_text":"- Platelet count ≥100,000 x 109/µL independent of transfusion and/or growth factors within 3 months prior to randomization"}
• {"criterion_text":"- Serum albumin ≥3.0 g/dL"}
• {"criterion_text":"- Serum creatinine <2.0 × upper limit of normal"}
• {"criterion_text":"- Serum potassium ≥3.5 mmol/L"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN"}
• {"criterion_text":"- Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patients who have received the information sheet and signed the informed consent form"}
• {"criterion_text":"- Patients must be willing to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures"}

Exclusion criteria

• {"criterion_text":"- Patients with severe erectile dysfunction according to international index of erectile function (IIEF-5) questionnaire (score 1-7)"}
• {"criterion_text":"- Allergies, hypersensitivity or known intolerance to the study drugs or excipients."}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Current evidence of uncontrolled hypertension or gastrointestinal disorder affecting absorption"}
• {"criterion_text":"- Patients already included in another clinical trial involving an experimental drug."}

Primary endpoints

• {"endpoint_text":"- EPIC-26 sexual domain score at 9 months after start of hormonal treatment (0 – 100 scale, with higher scores representing better sexual function)","definition_or_measurement_approach":"EPIC-26 sexual domain score at 9 months after start of hormonal treatment (0–100 scale; higher scores represent better sexual function)"}

Secondary endpoints

• {"endpoint_text":"- Quality of life will be assessed using EPIC-26 as well as the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C30 and PR25 as well as FACT-P","definition_or_measurement_approach":"Quality of life measured using EPIC-26, EORTC QLQ-C30, PR25 and FACT-P questionnaires"}
• {"endpoint_text":"- Acute as well as late toxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (published November 27, 2017)","definition_or_measurement_approach":"Toxicity assessed using CTCAE v5.0"}
• {"endpoint_text":"- Regarding efficacy, prostate-specific antigen (PSA) response rates, defined as a decline from baseline in PSA level of 80% or greater, as well as PSA complete response rates, defined as a decline from baseline in PSA level of 90% or greater, will be prospectively collected at the 4 treatment visits (i.e. at 0, 3, 6, and 9 months)","definition_or_measurement_approach":"PSA response: ≥80% decline from baseline; PSA complete response: ≥90% decline; collected at 0, 3, 6, 9 months"}
• {"endpoint_text":"- Metastasis-free survival","definition_or_measurement_approach":"Time to metastasis or death (metastasis-free survival), follow-up up to 5 years listed as an objective"}
• {"endpoint_text":"- Radiation therapy quality assurance","definition_or_measurement_approach":"Radiotherapy QA assessments (methodology not specified)"}

Belgium

Earliest CTIS Part Ii Submission Date

10-06-2024

Latest Decision Or Authorization Date

11-09-2025

Processing Time Days

458

Number Of Sites

7

Number Of Participants

202

Primary sponsor

Full Name

Ziekenhuis Aan De Stroom

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium

Third parties

• {"country":"","full_name":"Johnson and Johnson","duties_or_roles":"Monetary support","organisation_type":""}