NCT05008900CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- First submitted
- 12 Aug 2021
- Start date
- 22 Mar 2022
- Primary completion date
- 8 Jul 2024
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Prostate cancer
- NCT number
- NCT05008900
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 4
- From 22 Mar 2022 to the primary completion date, 8 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvic radiotherapy
- Other contraindications to radiotherapy
Other
- Active or post prostatectomy androgen deprivation use
Who the study is looking for
- Histologically-proven prostate cancer
- pT1-T4 pN0/Nx cM0
- PSA at BCR \>0.1 - \<0.3 ng/mL post-radical prostatectomy
- PSMA PET/CT negative at BCR post radical prostatectomy
- Planned SRT to prostate bed +/- pelvic lymph nodes
- ECOG 0 or 1
- Age ≥ 18 years
- Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Cancer Center Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.