Spots Global Cancer Trial Database for EVOLUTION: 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With mCRPC
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Trial Identification
Brief Title: EVOLUTION: 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With mCRPC
Official Title: Phase II Study of Radionuclide 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With MetastaticCastration Resistant Prostate Cancer (mCRPC)
Study ID: NCT05150236
Study Description
Brief Summary: This phase II study will investigate the activity and safety of radionuclide 177Lu-PSMA therapy versus 177Lu-PSMA in combination with Ipilimumab and Nivolumab in patients with metastatic castrate resistant prostate cancer (mCRPC).
Detailed Description: This is an open label, randomised, stratified, multicentre phase 2 clinical trial recruiting 110 participants over 18 months and followed for 12 months. Participants will be randomised to 177Lu-PSMA in combination with Ipilimumab and Nivolumab and 177Lu-PSMA alone in a 2:1 ratio (using minimisation with a random component) stratified by prior exposure to docetaxel.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
St Vincents Hospital, Darlinghurst, New South Wales, Australia
Calvary Mater Newcastle, Newcastle, New South Wales, Australia
Royal Brisbane and Womens hospital, Herston, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Austin Health, Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Alfred Hospital, Melbourne, Victoria, Australia
Sir Charles Gairdner, Nedlands, Western Australia, Australia
Contact Details
Name: Shahneen Sandhu, MBBS, FRACP
Affiliation: Peter MacCallum Cancer Centre, Australia
Role: STUDY_CHAIR
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