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

RECRUITING

I'm interested ...!!

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.

Conditions:

🦠 Prostate Cancer

🗓️ Study Start (Actual) 3 August 2023

🗓️ Primary Completion (Estimated) December 2028

✅ Study Completion (Estimated) December 2033

👥 Enrollment (Estimated) 20

🔬 Study Type INTERVENTIONAL

📊 Phase EARLY_PHASE1

Locations:

📍 Baltimore, Maryland, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 18 Years to 100 Years (ADULT, OLDER_ADULT)

Sexes Eligible for Study: MALE

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 1 March 2019
First Submitted that Met QC Criteria 1 March 2019
First Posted 4 March 2019

Study Record Updates

Last Update Submitted that Met QC Criteria 22 December 2023
Last Update Posted 26 December 2023
Last Verified December 2023