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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
Who can join
Ages 18 to 100 · Men
Full eligibility 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
About the study
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.
What is being tested
- Focal brachytherapy with PSMA PET imaging (radiation)
- (18F)DCFPyL (drug)
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Participants: 20 · Started: Aug 3, 2023
Contact the study team
- Daniel Song, MD · Phone: (410) 502-5875
- Dana Kaplin · Phone: (410) 614-3950
Official record on ClinicalTrials.gov — NCT03861676
Locations in the U.S.
| Maryland | SKCCC at Johns Hopkins, Baltimore |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.