Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy - STAMPEDE

niversity College London0 sites12,000 target enrollmentAugust 21, 2020

Overview

No summary available.

Registry

who.int

Start Date

August 21, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

niversity College London

•Participants must fulfil both of the criteria in Section 1 or at least one criterion in Section 2 or at least one criterion in Section 3 of the protocol. Additionally, all patients must fulfil the criteria in Section 4\.
•1\. High\-Risk Newly\-Diagnosed Non\-Metastatic Node\-Negative Disease
•At least two of: T category T3/4, PSA \=40ng/ml or Gleason sum score 8\-10
•Intention to treat with radical radiotherapy (unless there is a contra\-indication; exemption can be sought in advance of consent, after discussion with CTU)
•2\. Newly\-Diagnosed Metastatic Or Node\-Positive Disease
•At least one of:
•Stage T\-any N\+ M0
•Stage T\-any N\-any M\+
•3\. Previously Radically Treated, Now Relapsing (Prior Radical Surgery And/or Radiotherapy)
•At least one of

•I.Prior systemic therapy for locally advanced or metastatic prostate cancer (except as listed in Section 4\.3\)
•II.Prior exposure to hormone therapy for a duration of \> 12 months, or prior exposure completing \< 12 months before randomisation
•III.Metastatic brain disease or leptomeningeal disease
•IV.Abnormal liver functions consisting of any of the following:
•Serum bilirubin \=1\.5 x ULN (except for participants with Gilbert’s disease, for whom the upper limit of serum bilirubin is 51\.3µmol/l or 3mg/dl)
•Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \=2\.5 x ULN \- site must indicate at randomisation whether one or both tests are performed at site. Where both results are available both must confirm eligibility.
•V.Any other previous or current malignant disease which, in the judgement of the responsible clinician, is likely to interfere with STAMPEDE treatment or assessment
•VI.Any surgical wound (e.g. TURP) which in the judgement of the responsible clinician may interfere with or be exacerbated by protocol treatment
•VII.Participants with significant cardiovascular disease, including:
•Severe/unstable angina