DOCETAXEL for Prostate cancer | Metastatic castration-resistant prostate cancer

Inclusion criteria

• {"criterion_text":"- Histologically- or cytologically-confirmed prostate adenocarcinoma.\n- Performance status ECOG <2\n- Ability to fill the quality of life questionnaire\n- Written informed consent\n- Metastatic Castration Resistant Prostate Cancer (mCRPC)\n- Previous detection of BRCA mutation\n- Treatment for mCRPC with an ARSI and subsequent treatment with olaparib\n- Progressive disease while receiving Olaparib documented by: I.\tIncrease in measurable disease (RECIST 1.1), and/or II.\tAppearance of new lesions, including those on bone scan (≥2 new lesions on 2 consecutive bone scans if progression disease diagnosed on bone scan only) consistent with progressive prostate cancer, and/or III.\tRising PSA defined as 2 sequential increases above a previous lowest reference value. Each value must be obtained at least 1 week apart. A PSA value of at least 2 ng/ml is required at study entry. For patients evaluated with PET the progressive disease should be documented by at least one of the following criteria: I. appearance of at least two new lesions, and/or II. Increase of ≥30% of the uptake or of the tumoral volume\n- Effective castration (serum testosterone levels ≤0.50 ng/dL) by orchiectomy and/or LHRH agonists or antagonist with or without anti-androgens.\n- Age ≥18 years"}

Exclusion criteria

• {"criterion_text":"- Prior chemotherapy for prostate cancer\n- Inability to ensure follow-up\n- Any other condition which in the judgment of the investigator would place the subject at undue risk or interfere with the study.\n- Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to >30% of bone marrow.\n- History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease.\n- Inadequate organ and bone marrow function as evidenced by: a.\tHemoglobin <10.0 g/dL b.\tAbsolute neutrophil count <1.5 x 109/L, c.\tPlatelet count <100 x 109/L, d.\tAST and/or ALT >1.5 x ULN; e.\tTotal bilirubin >1.5 x ULN, f.\tSerum Creatinine >1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated either according to Cockcroft-Gault formula. Creatinine clearance <60 mL/min will exclude the patient\n- Contraindications to the use of corticosteroid treatment.\n- Clinically significant cardiovascular disease including the following: a.\tMyocardial infarction within 6 months before screening; b.\tUncontrolled angina within 3 months before screening; c.\tCongestive heart failure New York Heart Association class 3 or 4, or a history of congestive heart failure New York Heart Association class 3 or 4, unless a screening echocardiogram or multigated acquisition scan performed within 3 months before randomization demonstrates a left ventricular ejection fraction ≥ 50%; d.\tHistory of clinically significant ventricular arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes); e.\tHistory of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place; f.\tHypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mm Hg) at screening; g.\tBradycardia as indicated by a heart rate of < 45 beats per minute on the screening electrocardiogram (ECG) and on physical examination; h.\tUncontrolled hypertension as indicated by systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg at screening.\n- Any of the following within 3 months prior to randomization: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.\n- Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1) bladder cancer are allowed, as well as any other cancer for which chemotherapy has been completed >5 years ago and from which the patient has been disease-free for >5 years.\n- Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization"}

Primary endpoints

• {"endpoint_text":"- Rate of patients without disease progression after 4 months from the treatment start according to PCWG3","definition_or_measurement_approach":"Rate assessed according to PCWG3 (Prostate Cancer Working Group 3) criteria; proportion of patients without progression at 4 months from treatment start."}

Secondary endpoints

• {"endpoint_text":"- Progression free-survival by Kaplan-Meier method","definition_or_measurement_approach":"Progression-free survival estimated using the Kaplan-Meier method."}
• {"endpoint_text":"- Overall survival by Kaplan-Meier method","definition_or_measurement_approach":"Overall survival estimated using the Kaplan-Meier method."}
• {"endpoint_text":"- Biochemical response rate","definition_or_measurement_approach":"Biochemical response rate (definition not further specified in available record)."}
• {"endpoint_text":"- Objective response rate according to RECIST criteria","definition_or_measurement_approach":"Objective response rate assessed according to RECIST criteria."}
• {"endpoint_text":"- Adverse events type and grade according to CTCAE v.5","definition_or_measurement_approach":"Adverse events collected and graded per CTCAE v5."}
• {"endpoint_text":"- Scales of FACT-P and BPI questionnaires","definition_or_measurement_approach":"Patient-reported outcomes measured using FACT-P (Functional Assessment of Cancer Therapy - Prostate) and BPI (Brief Pain Inventory) questionnaires."}

Italy

Earliest CTIS Part Ii Submission Date

23-07-2024

Latest Decision Or Authorization Date

18-11-2024

Processing Time Days

118

Number Of Sites

11

Number Of Participants

157

Primary sponsor

Full Name

Azienda Provinciale Per I Servizi Sanitari

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy