Timing of Post-prostatectomy PSMA Imaging

University Health Network, Toronto4 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Prostate Cancer Prostatectomy

Interventions

Salvage radiotherapyRADIATION

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 7 years

Data from ClinicalTrials.gov

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