RecruitingEarly Phase 1NCT03861676

Image-guided Focal Brachytherapy Utilizing Combined 18F-DCFPyl PET/CT

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


Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

20 participants

Start Date

Aug 3, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The Principal Investigator's (PI) working hypothesis is that the PI can utilize the high predictive value of 18F-DCFPyl PSMA to identify clinically significant tumors in patients who will undergo brachytherapy, as well as areas which are uninvolved or contain only clinically insignificant disease. In the PI's clinical trial, the uninvolved regions (as defined by combined PET-MR-biopsy data) will not be targeted and receive only fall-off dose, which we have shown to be associated with reductions in toxicity.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a targeted internal radiation approach called focal brachytherapy — which delivers radiation only to the specific area of the prostate where cancer has been confirmed using a special PET scan (PSMA PET) and MRI — for men with low-to-intermediate risk prostate cancer, with the aim of treating the cancer while minimizing damage to surrounding healthy tissue. **You may be eligible if...** - You have been diagnosed with prostate adenocarcinoma - Your cancer is early-stage (T1c or T2a), with no known lymph node or distant spread - Your Gleason score is 6 or 7 (low to intermediate risk) - Your prostate is not too large (under 60cc) - Your urinary symptoms are not severe (IPSS score 20 or below) - You are able to undergo the PSMA PET scan for staging purposes **You may NOT be eligible if...** - You have previously had pelvic radiation therapy - You have metal implants or claustrophobia that prevent MRI - You have had another cancer in the past 3 years - You have implanted devices that would block visibility of implanted radiation sources during the procedure - You have major medical or psychiatric conditions that would prevent completing treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONFocal brachytherapy with PSMA PET imaging

Focal brachytherapy with PSMA PET imaging. Focal (partial prostate gland) brachytherapy following 18F-DCFPyl PET/CT radiotracer imaging. Patients will also undergo pre-treatment transperineal mapping biopsy.

DRUG(18F)DCFPyL

18F-DCFPyl PET/CT scan


Locations(1)

SKCCC at Johns Hopkins

Baltimore, Maryland, United States

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NCT03861676


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