Timing of Post-prostatectomy PSMA Imaging

Phase 2

Recruiting

• Conditions: Prostate Cancer; Prostatectomy
• Interventions: Radiation: Salvage radiotherapy

• Registration Number: NCT05008900
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-12
• Study First Submitted QC: 2021-08-12
• Study First Posted: 2021-08-17
• Study Start: 2022-03-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2030-09
• Study Completion: 2031-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 40

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.

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Exclusion Criteria

• Active or post prostatectomy androgen deprivation use
• Previous pelvic radiotherapy
• Other contraindications to radiotherapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surveillance	Salvage radiotherapy	Patients with early biochemical relapse of prostate cancer following radical prostatectomy who have a PSA greater than or equal to 0.1 to less than 0.3 ng/mL with negative PSMA PET/CT will go on surveillance. Routine PSA will be conducted and a repeat PSMA PET/CT imaging will be conducted when the PSA rises to greater than 0.5 to less than 1.0 ng/mL.

Primary Outcome Measures

Name	Time	Method
Surveillance with delayed PSMA PET scan	7 years	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.

Trial Locations

Locations (1)

Princess Margaret Cancer Center; 🇨🇦 Toronto, Ontario, Canada