Actively Recruiting
Prospective Evaluation of PSMA PET Imaging in Surveillance Post-Focal Therapy for Prostate Cancer (PSMA-FT Surveillance Study)
Led by University of Chicago · Updated on 2026-02-17
62
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Chicago
Lead Sponsor
B
Blue Earth Diagnositcs
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how adding a PSMA PET scan to standard multiparametric MRI can improve detection of prostate cancer recurrence in men who have had focal therapy. This study focuses on men with prostate cancer who have undergone partial gland ablation and aims to improve imaging methods to better identify cancer recurrence after treatment. The research is sponsored by the University of Chicago and funded by Blue Earth Diagnostics, a molecular imaging company. Participants will receive a PSMA PET/CT scan in addition to their routine MRI scans during the 12 months following focal therapy. Focal therapy itself is part of standard clinical care and not provided by the study. Participants will also give blood, urine, and optionally tissue samples for research purposes. Quality of life questionnaires will be completed to assess participant well-being. During the study, participants will attend visits for about one year after focal therapy for imaging and monitoring. Researchers will measure whether adding the PSMA PET scan improves cancer detection compared to MRI alone. Secondary goals include evaluating the value of PSMA PET combined with MRI and PSA testing in diagnosing significant cancer recurrence. Safety and adherence will be monitored through regular clinical follow-up and sample collections.
CONDITIONS
Brief Title
PSMA PET for Surveillance After Focal Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 years or older
- Ability to understand and provide written informed consent
- Histologically confirmed prostate cancer diagnosed by prostate biopsy within 1 year prior to consent
- Scheduled for focal therapy (partial gland ablation) within 6 months after consent
- Confirmed non-metastatic prostate cancer by standard imaging within 6 months before enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less, or Karnofsky score of 60% or higher
- Fit for general anesthesia and focal therapy procedure including adequate prostate imaging and positioning tolerance
You will not qualify if you...
- Prior or current prostate cancer treatments including chemotherapy, hormone therapy, radiotherapy, or surgery within the last 12 months
- Locally advanced, nodal, or metastatic prostate cancer
- Unable to undergo pelvic multiparametric MRI due to claustrophobia, pacemaker, metallic implants, or allergy to contrast
- Uncontrolled or major debilitating inter-current illness
- Judged unsuitable by investigator or principal investigator for participation or unlikely to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - About 12 months
Participants who undergo routine focal therapy are observed with additional PSMA PET imaging alongside regular follow-up MRI and prostate biopsy as part of clinical care.
Follow-up visits for imaging and assessments over 12 months
Trial Site Locations
Total: 1 location
1
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
A
Abhinav Sidana, MD
A
Abhinav Sidana, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here