Timing of Post-prostatectomy PSMA Imaging (TOPP)

University Health Network, Toronto

Status and phase: Enrolling; Phase 2

Conditions: Prostatectomy; Prostate Cancer

Treatments: Radiation: Salvage radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05008900

21-5040

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Surveillance

Experimental group

Description:

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.

Treatment:

Radiation: Salvage radiotherapy

Salvage radiotherapy

No Intervention group

Description:

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.