PSMA PET for Surveillance After Focal Therapy

NCT07115914 | Recruiting

• 1 other identifier: 24-2132
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Prostate Cancer (Adenocarcinoma); Prostate Cancer (Diagnosis); Prostate Cancer Metastatic Disease

Keywords

focal therapy; prostate cancer; prostate cancer patient

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (2)

• Value of baseline PSMA-PET in combination with MRI imaging for selecting patients for partial gland ablation.

  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

  6-12 Months after focal therapy

Study Arms (1)

All participants

EXPERIMENTAL

All people enrolled in this study will participate in the same study arm and will receive the same study interventions.

Radiation: PSMA PET/CT scan

Interventions

PSMA PET/CT scan RADIATION

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.

All participants

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• Blue Earth Diagnositcs: collaborator

Study Sites (1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Abhinav Sidana, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abhinav Sidana, MD

CONTACT

(773) 702-4400; abhinav.sidana@bsd.uchicago.edu

Abhinav Sidana, MD

CONTACT

cancerclinicaltrials@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)