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Timing of Post-prostatectomy PSMA Imaging

Prostate Cancer | 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.

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Participation Requirements

  • Sex:

    MALE

  • Eligible Ages:

    18 and up

Participation Criteria

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

Study Location

Princess Margaret Cancer Center
Princess Margaret Cancer Center
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Srinivas Raman, MD

[email protected]
416-946-2320
Study Sponsored By
University Health Network, Toronto
Participants Required
More Information
Study ID: NCT05008900