Using PSMA PET with MRI to watch for prostate cancer returning after focal therapy

Prospective Evaluation of PSMA PET Imaging in Surveillance Post-Focal Therapy for Prostate Cancer (PSMA-FT Surveillance Study)

We will try adding a PSMA PET scan to routine MRI follow-up to see if it finds prostate cancer coming back sooner in men who had focal (partial gland) therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University of Chicago (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT07115914 on ClinicalTrials.gov

What this trial studies

This study adds a PSMA PET/CT scan to the usual multiparametric MRI follow-up for men after focal (partial gland) therapy for prostate cancer. Participants will receive standard clinical care including mpMRI and prostate biopsy, and will get an additional PSMA PET within about 12 months after treatment. Blood, urine, and optional tissue samples will be collected and participants will complete quality-of-life questionnaires. The research will compare imaging results to see whether PSMA PET detects recurrences that mpMRI or standard follow-up miss.

Who should consider this trial

Good fit: Men aged 18 or older with biopsy-proven prostate cancer who have chosen focal (partial gland) ablation and who had the required systematic plus targeted prostate biopsy within the past year are the intended participants.

Not a fit: Patients who did not undergo focal therapy, who cannot have PET/CT or MRI scans, or whose disease is widely metastatic are unlikely to benefit from this specific surveillance approach.

Why it matters

Potential benefit: If successful, this approach could help doctors detect recurrences earlier and guide timely additional treatment after focal therapy.

How similar studies have performed: PSMA PET has been shown in other settings to detect recurrent prostate cancer more sensitively than conventional imaging, but its specific role in surveillance after focal therapy is still being explored.

Eligibility criteria

Inclusion Criteria:

1. Subjects must be male (assigned male at birth) and 18 years or older.
2. Subjects must demonstrate the ability to understand and provide written informed consent.
3. Subjects must have histologically confirmed prostate cancer ( PCa) Note: Recruitment will be limited to a maximum of 50% of subjects with favorable intermediate-risk prostate cancer (PCa) Note: The histopathologic diagnosis must be obtained via "Prostate Biopsy (PB)", which for the purposes of the present study, is defined as both a systematic 12-core sextant random prostate biopsy and a targeted prostate biopsy. The targeted prostate biopsy can be performed via in-bore multiparemetric (mp) magnetic resonance imaging (MRI) prostate biopsy, cognitive mpMRI/ultrasound fusion prostate biopsy or software mpMRI/ultrasound fusion prostate biopsy. This "PB" must not be obtained greater than 1 year from the date of consent.
4. Subjects must have chosen to get focal therapy (partial gland ablation) for the treatment of prostate cancer and must be scheduled for partial gland ablation/focal therapy with any energy modality within 6 months following informed consent.
5. Subjects must have confirmed non-metastatic PCa following SOC screening for patients with unfavorable intermediate-risk and high risk PCa, a combination of computed tomography imaging of the abdomen and pelvis (CTAP) and technetium-99-mDP nuclear medicine bone scan (BS) and/or PSMA-PET imaging prior to enrollment. The imaging studies should be obtained within 6-months of enrollment.
6. Subjects must be designated as Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 or Karnofsky Performance Status Scale Score ≥ 60%, (see Appendix A).
7. Subjects must be fit to undergo general anesthesia and the FT surgical procedure, which includes adequate visualization of the prostate gland on transrectal ultrasound imaging, access to the urethra, perineum and rectum, as well as be tolerant of lithotomy positioning in the opinion of the treating investigator or the operating surgeon(s) if not the same as the treating investigator.

Exclusion Criteria:

1. Subject had prior or current PCa therapies, such as biologic, chemotherapy, hormone therapy, radiotherapy or surgery for PCa within last 12 months. Subjects who received radiation and/or androgen deprivation therapy for prostate cancer more than 12 months prior to diagnosis of recurrent prostate cancer will be eligible for the trial.
2. Subjects with locally advanced, nodal or metastatic prostate cancer.
3. Subjects who are unfit for pelvic mpMRI scanning (e.g., severe claustrophobia), permanent cardiac pacemaker, metallic implants that are likely to contribute to significant image artifacts, allergy or contraindication to gadolinium contrast agent.
4. If the subject has an uncontrolled or major debilitating inter-current illness.
5. Judgment by the treating investigator or PI that the subject is unsuitable to participate in the study and the subject is unlikely to comply with study procedures, restrictions, and requirements.

Where this trial is running

Chicago, Illinois

• University of Chicago Medicine Comprehensive Cancer Center — Chicago, Illinois, United States (Recruiting)

Study contacts

• Principal investigator: Abhinav Sidana, MD — University of Chicago
• Study coordinator: Abhinav Sidana, MD

Conditions Prostate Cancer; Prostate Cancer Metastatic Disease; focal therapy; prostate cancer; prostate cancer patient