Enzalutamide for Metastatic prostate cancer

Inclusion criteria

• {"criterion_text":"- Male aged 18 or older with metastatic adenocarcinoma of the prostate defined by Documented histopathology or cytopathology of prostate adenocarcinoma from a biopsy of a metastatic site OR Documented histopathology of prostate adenocarcinoma from a TRUS biopsy, radical prostatectomy, or TURP and metastatic disease consistent with prostate cancer. OR Metastatic disease typical of prostate cancer (i.e. involving bone or pelvic lymph nodes or para-aortic lymph nodes) AND a serum concentration of PSA that is rising and >20ng/mL"}
• {"criterion_text":"- Signed, written, informed consent"}
• {"criterion_text":"- Target or non-target lesions according to RECIST 1.1"}
• {"criterion_text":"- Adequate bone marrow function: Hb ≥100g/L and WCC ≥ 4.0 x 109/L and platelets ≥100 x 109/L."}
• {"criterion_text":"- Adequate liver function: ALT < 2 x ULN and bilirubin < 1.5 x ULN, (or if bilirubin is between 1.5-2x ULN, they must have a normal conjugated bilirubin). If liver metastases are present ALT must be < 5xULN"}
• {"criterion_text":"- Adequate renal function: calculated creatinine clearance > 30 ml/min (Cockroft-Gault)"}
• {"criterion_text":"- ECOG performance status of 0-2. Patients with performance status 2 are only eligible if the decline in performance status is due to metastatic prostate cancer."}
• {"criterion_text":"- Study treatment both planned and able to start within 7 days after randomisation."}
• {"criterion_text":"- Willing and able to comply with all study requirements, including treatment and required assessments"}
• {"criterion_text":"- Has completed baseline HRQL questionnaires UNLESS is unable to complete because of limited literacy or vision"}

Exclusion criteria

• {"criterion_text":"- Prior cytotoxic chemotherapy for prostate cancer, but up to 2 cycles of docetaxel chemotherapy for metastatic disease is permitted.as per section 5.3.2.4 is allowed."}
• {"criterion_text":"- Prior ADT for prostate cancer (including bilateral orchidectomy), except in the following settings: a. Started less than 12 weeks prior to randomisation AND PSA is stable or falling. The 12 weeks starts from whichever of the following occurs earliest: first dose of oral anti- androgen, LHRHA, or surgical castration. b. In the adjuvant setting, where the completion of adjuvant hormonal therapy was more than 12 months prior to randomisation AND the total duration of hormonal treatment did not exceed 24 months. For depot preparations, hormonal therapy is deemed to have started with the first dose and to have been completed when the next dose would otherwise have been due, e.g. 12 weeks after the last dose of depot goserelin 10.8mg."}
• {"criterion_text":"- Participation in other clinical trials of investigational agents for the treatment of prostate cancer or other diseases."}
• {"criterion_text":"- Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components"}
• {"criterion_text":"- History of a. seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma). b. loss of consciousness or transient ischemic attack within 12 months of randomization c. significant cardiovascular disease within the last 3 months including: myocardial infarction, unstable angina, congestive heart failure (NYHA functional capacity class II or greater, Refer to Appendix 6), ongoing arrhythmias of Grade >2 [CTCAE, version 4.03], thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism). Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed."}
• {"criterion_text":"- Life expectancy of less than 12 months."}
• {"criterion_text":"- History of another malignancy within 5 years prior to randomisation, except for either non- melanomatous carcinoma of the skin or, adequately treated, non-muscle-invasive urothelial carcinoma of the bladder (Tis, Ta and low grade T1 tumours)."}
• {"criterion_text":"- Concurrent illness, including severe infection that might jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety a. HIV-infection is not an exclusion criterion if it is controlled with anti-retroviral drugs that are unaffected by concomitant enzalutamide."}
• {"criterion_text":"- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse"}
• {"criterion_text":"- Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception."}

Primary endpoints

• {"endpoint_text":"- Overall survival (death from any cause)","definition_or_measurement_approach":"Overall survival measured as death from any cause"}

Secondary endpoints

• {"endpoint_text":"- Prostate specific antigen progression free survival (PCGW2)","definition_or_measurement_approach":"Prostate specific antigen progression-free survival (PCGW2) as stated"}
• {"endpoint_text":"- Clinical progression free survival (imaging, symptoms, signs)","definition_or_measurement_approach":"Clinical progression-free survival assessed by imaging, symptoms, signs"}
• {"endpoint_text":"- Adverse events (CTCAE v4.03)","definition_or_measurement_approach":"Adverse events graded by CTCAE v4.03"}
• {"endpoint_text":"- Health related quality of life (EORTC QLQ C-30, PR-25 and EQ-5D-5L)","definition_or_measurement_approach":"Health-related quality of life measured using EORTC QLQ C-30, PR-25 and EQ-5D-5L instruments"}
• {"endpoint_text":"- Health outcomes relative to costs (incremental cost effectiveness ratio)","definition_or_measurement_approach":"Health outcomes relative to costs assessed as incremental cost effectiveness ratio"}

Ireland

Earliest CTIS Part Ii Submission Date

01-10-2024

Latest Decision Or Authorization Date

05-08-2025

Processing Time Days

307

Number Of Sites

7

Number Of Participants

82

Primary sponsor

Full Name

Cancer Trials Ireland

Organisation Type

Patient organisation/association

Country Of Registered Address

Ireland