Image-guided focal brachytherapy for prostate cancer using advanced PET imaging
Image-guided Focal Brachytherapy Utilizing Combined 18F-DCFPyl PET/CT and Dynamic Dosimetry With Registered Ultrasound and Fluoroscopy for Localized Prostate Cancer
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
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Male |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT03861676 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies utilizing PSMA-targeted imaging have shown promising results, indicating that this approach may be effective in improving prostate cancer treatment outcomes.
Eligibility criteria
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 this trial is running
Baltimore, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.