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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: abhinav.sidana@bsd.uchicago.edu
• Phone: (773) 702-4400

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adaptive intraoperative biopsy system for prostate cancer using imaging and metabolic feedback

  Aiming to test a smart biopsy approach that combines preoperative imaging with real-time metabolic signals to guide where to take prostate biopsy cores for better precision in men suspected of prostate cancer.

  Recruiting at 4 sites Shanghai Zhongshan Hospital · Shanghai and 3 other locations · NCT07856017

• Early postoperative PSA after prostate removal as a predictor of cancer outcomes

  We will test whether early PSA levels after prostate removal can help predict long-term cancer outcomes in men undergoing radical prostatectomy.

  Recruiting Lithuanian University of Health Sciences · Kaunas, Kauno · NCT07516886

• Epidemiology, diagnosis, and treatment patterns of prostate cancer in Algeria

  This project collects medical and treatment information to see how prostate cancer is diagnosed and managed in Algerian men with confirmed disease.

  Recruiting at 21 sites Société Algérienne de Formation et Recherche en Oncologie · Adrar, Algeria and 23 other locations · NCT07484971

• Fezolinetant to reduce hot flashes in men on androgen-deprivation therapy

  This trial will test whether taking fezolinetant once daily for 4 weeks reduces how often and how severe hot flashes are in men with prostate cancer who are on androgen-deprivation therapy.

  Recruiting Phase 2 Brigham and Women's Hospital · Boston, Massachusetts · NCT06957691

• 68Ga-XMFH01 PET/FL imaging to guide prostate cancer surgery

  This study tests a new dual-modality imaging probe, 68Ga-XMFH01, to preoperatively detect prostate cancer and guide the surgeon with fluorescence during operations in adults with newly diagnosed prostate cancer.

  Recruiting The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT07885423

• Hugo Robotic Prostatectomy in an Ambulatory Surgery Center

  This study tests the use of the Hugo robotic system for prostate removal in adult men treated at an outpatient surgical center.

  Recruiting Central Ohio Urology Group · Columbus, Ohio · NCT07875192

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.