RECRUITINGEarly Phase 1INTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

RADIATION

Focal 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