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A Phase II Randomized Feasibility Study Comparing Early Salvage Radiotherapy Versus Surveillance With Delayed Repeat PSMA PET/CT Imaging in Patients Presenting With Early Biochemical Relapse of Prostate Cancer Following Radical Prostatectomy
The investigators will randomize patients presenting with early BCR with a negative baseline PSMA PET/CT, to upfront SRT or surveillance. Early BCR is defined as a PSA relapse of \>0.1 to \<0.3 ng/mL. Patients in the surveillance arm will be monitored with PSA every 3 months. A repeat PSMA PET/CT will be undertaken when the PSA reaches a target level of \>0.5 to \<1.0 ng/mL. Both early radiation treatment and surveillance with repeat PSMA PET/CT imaging are within patterns of practice locally; therefore, the investigators believe that there is clinical equipoise on this subject.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Start Date
March 22, 2022
Primary Completion Date
July 8, 2024
Completion Date
July 8, 2024
Last Updated
March 5, 2026
4
ACTUAL participants
Salvage radiotherapy
RADIATION
Lead Sponsor
University Health Network, Toronto
NCT05691465
NCT04550494
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