NCT05008900

Timing of Post-prostatectomy PSMA Imaging

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Prostate Cancer
• Prostatectomy

Interventions

Type	Name	Description
RADIATION	Salvage radiotherapy	Standard of care salvage radiotherapy to the prostate bed which may include the lymph nodes.

Timeline

• Start date: 2022-03-22
• Primary completion: 2024-07-08
• Completion: 2024-07-08
• First posted: 2021-08-17
• Last updated: 2026-03-05

Locations

1 site across 1 country: Canada