Multimodal Approach in Patients With mHSPC. Randomized Trial of APA+ADT vs APA-ADT and Local Treatment
APPROACH : Multimodal Approach in Patients With mHSPC. A Pragmatic Randomized Trial of Apalutamide Plus Androgen Deprivation Therapy (APA-ADT) Versus APA-ADT Plus Local Treatment. A Meet-URO 29 Study
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano + ASST Santi Paolo e Carlo, European Institute of Oncology
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Radiographic Progression-Free Survival (rPFS)
Time frame: Up to 48 months
Secondary Endpoints
Local event - free survival
Local treatment - free survival
Eligibility Criteria
Inclusion Criteria: * Age \> 18 * Histologically confirmed diagnosis of prostate adenocarcinoma * Metastatic disease documented by ≥1 bone lesion with Technetium 99m (99mTc) bone scan. Individuals with only one bone lesion should have confirmation of that lesion on CT or MRI. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) Grade ≤ 2 * No previous treatment with antiandrogens or GnRH analogues, or a treatment ≤ 3 months. * No previous systemic or local treatment for prostate adenocarcinoma, including pelvic radiotherapy. * Laboratory values at the time of screening: a. Neutrophils ≥ 1500/μL b. Hemoglobin ≥ 9.0 mg/μL (no transfusions in the past 28 days) c. Platelets ≥ 100,000/μL d. Creatinine ≤ 2 x upper limit of normal and serum albumin ≥ 3.0 g/dL f. Total bilirubin ≤ 1.5 x upper limit of normal \[NOTE: In subjects with Gilbert syndrome, if total bilirubin is \>1.5 x ULN, measure direct and indirect bilirubin, and if direct bilirubin is ≤ 1.5 x ULN subjects may be…
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