CompletedPhase 2

Timing of Post-prostatectomy PSMA Imaging

Canada4 participantsStarted 2022-03-22

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Surveillance with delayed PSMA PET scan

Timeframe: 7 years

Trial details

NCT IDNCT05008900

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-08

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