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Clinical trial Recruiting at 1 site Early Phase 1 Interventional Ages 18 to 100 Men only

Image-guided focal brachytherapy for prostate cancer using advanced PET imaging

Official title: Image-guided Focal Brachytherapy Utilizing Combined 18F-DCFPyl PET/CT and Dynamic Dosimetry With Registered Ultrasound and Fluoroscopy for Localized Prostate Cancer

Run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · NCT03861676 · Data updated 2026-11-12

This study is testing a new way to treat prostate cancer by using advanced imaging to target only the tumors that need treatment while protecting healthy areas to reduce side effects.

Quick facts

PhaseEarly Phase 1
Study typeInterventional
Ages18 Years to 100 Years
SexMen only
Enrollment20 (estimated)
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Academic / other
Drugs / interventionsradiation
Locations1 site (Baltimore, Maryland)
StatusRecruiting
StartedAugust 3, 2023
Main results expectedDecember 2028
Study endsDecember 2033
Registry record updatedFebruary 13, 2026
Trial IDNCT03861676 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include men with localized adenocarcinoma of the prostate, specifically those with Gleason scores of 6-7 and clinical stages T1c to T2a.

Probably not a fit

Patients with a history of pelvic radiation therapy or significant medical conditions that could interfere with treatment may not benefit from this study.

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

What this trial studies

This clinical trial aims to improve the treatment of prostate cancer by utilizing 18F-DCFPyl PET/CT imaging to accurately identify clinically significant tumors for focal brachytherapy. The study focuses on targeting only the areas of the prostate that require treatment while sparing uninvolved regions to reduce toxicity. By leveraging the high predictive value of PSMA expression, the trial seeks to enhance the precision of prostate cancer treatment and minimize side effects associated with conventional therapies. Participants will undergo imaging and treatment at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and less toxic treatment options for patients with prostate cancer.

How similar studies have gone: Other studies utilizing PSMA-targeted imaging have shown promising results, indicating that this approach may be effective in improving prostate cancer treatment outcomes.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Adenocarcinoma of the prostate
* Performance Status \< 2
* Clinical stages (not radiographic stage) T1c - T2a, Nx or N0, Mx or M0
* Gleason 6-7 cancer
* Prostate volume \< 60 cc (if MRI and TRUS have conflicting values, then MRI value will be utilized)
* International Prostate symptom score (IPSS) 20 or less
* Ability to undergo DCF-Pyl PSMA PET as part of pretreatment staging
* Signed study-specific consent form prior to registration

Exclusion Criteria:

* Prior history of pelvic radiation therapy
* Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.
* Implanted device or apparatus which obstruct visibility of the implanted sources on fluoroscopy
* Metallic implants, claustrophobia not amenable to medication, or known contraindications to undergoing MR scanning
* History of other malignancy diagnosed within the past 3 years

Where it's running

  • SKCCC at Johns Hopkins
    Baltimore, Maryland, United States     Recruiting

Study contacts

  • Principal investigator: Daniel Song, MD — Johns Hopkins University
  • Study coordinator: Daniel Song, MD
  • Email: dsong2@jhmi.edu
  • Phone: (410) 502-5875

Similar studies

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

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.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.