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Timing of Post-prostatectomy PSMA Imaging

Timing of Post-prostatectomy PSMA Imaging

Recruiting
18 years and older
Male
Phase 2

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Overview

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

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 details
    Prostate Cancer
    Prostatectomy

NCT05008900

University Health Network, Toronto

23 June 2024

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