Prostate Cancer Clinical Trial
— TOPPOfficial title:
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | September 2031 |
Est. primary completion date | September 2030 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Active or post prostatectomy androgen deprivation use - Previous pelvic radiotherapy - Other contraindications to radiotherapy |
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Cancer Center | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surveillance with delayed PSMA PET scan | This study will assess the feasibility of surveillance with delayed repeat PSMA PET/CT in patients with BCR of prostate cancer following radical prostatectomy with negative baseline PSMA PET/CT. A treating physician questionnaire will be completed prior to screening and enrollment, as well as PSA results every three months for surveillance patients. | 7 years |
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