Timing of Post-prostatectomy PSMA Imaging

NCT05008900 | Completed Phase 2

• 1 other identifier: 21-5040
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Prostatectomy

Outcome Measures

Primary Outcomes (1)

• Surveillance with delayed PSMA PET scan

  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.

  7 years

Study Arms (2)

Surveillance

EXPERIMENTAL

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.

Radiation: Salvage radiotherapy

Salvage radiotherapy

NO INTERVENTION

Patients with early biochemical relapse of prostate cancer following radical prostatectomy who have a PSA of greater than or equal to 0.1 to less than 0.3 ng/mL with negative PSMA PET/CT will receive salvage radiotherapy to the prostate bed. This radiotherapy may or may not include the pelvic lymph nodes.

Interventions

Salvage radiotherapy RADIATION

Standard of care salvage radiotherapy to the prostate bed which may include the lymph nodes.

Surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 17, 2021
• Study Start: March 22, 2022
• Primary Completion: July 8, 2024
• Study Completion: July 8, 2024
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CA (1)