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Timing of Post-prostatectomy PSMA Imaging

RECRUITINGPhase 2Sponsored by University Health Network, Toronto
Actively Recruiting
PhasePhase 2
SponsorUniversity Health Network, Toronto
Started2022-03-22
Est. completion2030-09
Eligibility
Age18 Years+
SexMALE
Healthy vol.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.

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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

Conditions3

CancerProstate CancerProstatectomy

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