A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer
Studying Treatments in Patients Receiving Androgen Deprivation Therapy (ADT) for Metastatic Prostate Cancer: Evaluation of Drug and Radiation Efficacy: A 2nd Multi-arm Multi-stage Randomised Controlled Trial (STAMPEDE2).
Sponsor: University College, London + Cancer Research UK, Novartis
No open prediction endpoints
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Primary Endpoints (CT.gov)
Overall Survival (OS)
Time frame: Final analysis for each comparison triggered when adequate number of death events have occurred in control arm of each comparison. Anticipate final reporting for OS in Comparison S: ~84 months (7 years) from FPFV, P: ~64 months (5.3 years) from FPFV.
Secondary Endpoints
Failure-Free Survival (FFS)
Radiographic Progression-Free-Survival (rPFS)
Prostate cancer specific survival (PCSS)
Eligibility Criteria
Registration Inclusion Criteria: 1. At least 18 years old. 2. Histological confirmation of prostate adenocarcinoma or a strong clinical suspicion of prostate cancer with a plan to confirm the diagnosis formally before any future randomisation. 3. Confirmation of metastatic site(s) on CT/MRI and either bone or PET scan. Patients with metastatic disease meeting any of the following criteria are eligible: * Metastatic disease to the bone (in any distribution). * Non-regional lymph node metastases of any size or distribution. Lymph nodes that are only visible on PET will not be eligible as sites of metastasis. Note: If lymph nodes are the only site of metastases, then at least one must be at least 1.5cm in short axis AND outside of the pelvis. * Visceral metastases of any size or distribution. 4. Clinical presentation is: A. de novo. OR B. relapsed with; (1) continuing hormone sensitivity in the opinion of the investigator, and; (2) all hormone treatments (e.g., ADT and ARPI…
Read full criteria on CT.gov →✦ Analyst Commentary
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