PSMAddition: An International Prospective Open-label, Randomized, Phase III Study comparing 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
N
Nabil Adra, MD
Primary Investigator
Not Recruiting
18 years - 100 years
Male
Phase
3
1126 participants needed
2 Locations
Brief description of study
The primary objective of this study is to evaluate radiographic progression free survival
(rPFS) as assessed by Blinded Independent Review Committee (BIRC) in patients with mHSPC receiving Standard of Care and 177Lu-PSMA-617 versus patients receiving Standard of Care without 177Lu-PSMA-617.The primary clinical question of interest: what is the treatment effect based on rPFS for 177Lu-PSMA-617 in combination with Standard of Care versus Standard of Care alone in the treatment of adult male patients with mHSPC as defined through inclusion/exclusion criteria, regardless of study treatment discontinuation (STD) or start of new antineoplastic therapy prior to rPFS event.
(rPFS) as assessed by Blinded Independent Review Committee (BIRC) in patients with mHSPC receiving Standard of Care and 177Lu-PSMA-617 versus patients receiving Standard of Care without 177Lu-PSMA-617.The primary clinical question of interest: what is the treatment effect based on rPFS for 177Lu-PSMA-617 in combination with Standard of Care versus Standard of Care alone in the treatment of adult male patients with mHSPC as defined through inclusion/exclusion criteria, regardless of study treatment discontinuation (STD) or start of new antineoplastic therapy prior to rPFS event.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: metastatic prostate cancer,mHSPC
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Age: 18 years - 100 years
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Gender: Male
1. Adults males ≥18 years of age
2. Patients must have metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma (current or prior biopsy of the prostate and/or metastatic site)
Updated on
01 Aug 2024.
Study ID: 13157
