Prostate Cancer (Adenocarcinoma)NCT07115914
PSMA PET for Surveillance After Focal Therapy
A study testing PSMA PET/CT scan in people with Prostate Cancer (Adenocarcinoma) and Prostate Cancer (Diagnosis), run by University of Chicago at 1 site in United States.
Trial summary
This study is about adding PSMA PET (Prostate Specific Membrane Antigen- Positron Emission Tomography) to routine magnetic resonance imaging (MRI) scans to help detect prostate cancer recurrence in men who have undergone focal therapy for prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma), Prostate Cancer (Diagnosis), Prostate Cancer Metastatic Disease
- What is being tested?
- PSMA PET/CT scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2025to 1 Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be male (assigned male at birth) and 18 years or older.
- Subjects must demonstrate the ability to understand and provide written informed consent.
- 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.
- 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.
- 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.
- Subjects must be designated as Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 or Karnofsky Performance Status Scale Score ≥ 60%, (see Appendix A).
- 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.
Who cannot join
- 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.
- Subjects with locally advanced, nodal or metastatic prostate cancer.
- 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.
- If the subject has an uncontrolled or major debilitating inter-current illness.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Abhinav Sidana, MD contact
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Clinical Trials Intake, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Abhinav Sidana, MD
About this study
Official title: Prospective Evaluation of PSMA PET Imaging in Surveillance Post-Focal Therapy for Prostate Cancer (PSMA-FT Surveillance Study)
This study is about adding PSMA PET (Prostate Specific Membrane Antigen- Positron Emission Tomography) to routine magnetic resonance imaging (MRI) scans to help detect prostate cancer recurrence in men who have undergone focal therapy for prostate cancer. PSMA PET and multiparametric (mpMRI are both imaging tests that help detect prostate cancer in the body.
A PSMA PET scan, or prostate-specific membrane antigen positron emission tomography scan, is an imaging test that scans and takes pictures of the prostate. PSMA scans use a specialized radioactive imaging dye that sticks to the proteins that are typically found in prostate cancer cells. This imaging dye helps locate areas of prostate cancer anywhere in the body, both inside and outside prostate.
Read more
An mpMRI, or a multiparametric (mp) MRI scan, is also an imaging test that scans and takes detailed pictures of the prostate. Unlike regular MRIs, an mpMRI produces a more detailed image of the prostate. Similar to PET scans, mpMRI scans also use an imaging dye that helps the pictures of the prostate appear clearer on scans.
This study will be funded by Blue Earth Diagnostics, a molecular imaging company based in England.
Read the detailed description
People who agree to join the study will be asked to attend study visits for about 12 months after focal therapy. Focal therapy will not be given as part of research in this study. Study participants will receive focal therapy, a follow up MRI and prostate biopsy as part of regular clinical care for their cancer. This research study will add an additional PSMA PET to follow up after focal therapy.
Study participants will also be asked to:
- Give blood, urine and tissue samples for research purposes. The decision to give tissue samples is optional and not required for participation in study.
- Fill out quality of life questionnaires.
- Conditions
- Prostate Cancer (Adenocarcinoma), Prostate Cancer (Diagnosis), Prostate Cancer Metastatic Disease
- Being tested
- PSMA PET/CT scan
- Keywords
- focal therapy, prostate cancer, prostate cancer patient
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA PET/CT scanRadiation
A PSMA PET scan, or prostate-specific membrane antigen positron emission tomography scan, is an imaging test that scans and takes pictures of the prostate. PSMA scans use a specialized radioactive imaging dye that sticks to the proteins that are typically found in prostate cancer cells. This imaging dye helps locate areas of prostate cancer anywhere in the body, both inside and outside prostate.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All people enrolled in this study will participate in the same study arm and will receive the same study interventions. Receives: Radiation: PSMA PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if adding PSMA-PET scan to MRI will improve cancer detection
Number of identified cancer recurrences identified by PSMA-PET as compared to prostate biopsy
Measured: 1 year
Secondary outcomes (2)
Value of baseline PSMA-PET in combination with MRI imaging for selecting patients for partial gland ablation.
Determine the proportion of patients where baseline PSMA PET changed Focal Therapy selection/treatment plan (deemed ineligible or changed treatment margins or required additional preoperative biopsies).
Measured: End of study (about 5 years)
Value of PSMA-PET in combination with PSA for diagnosing Clinically significant cancer recurrence/residual disease after partial gland ablation
Determine the performance characteristics of PSMA PET alone in detecting CS recurrence (defined as Gleason Score greater than or equal to 2) on prostate biopsy following Focal therapy.
Measured: 6-12 Months after focal therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start19 Nov 2025
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnositcs
- Responsible party
- Sponsor
- Investigators
- Abhinav Sidana, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115914
- Sponsor's protocol ID
- 24-2132
- Status last verified
- Feb 2026
- First submitted
- 4 Aug 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes