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

Recruiting now · Early Phase 1

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT03861676

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

20

Starts

2023-08-03

Expected to finish

2033-12-01

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• SKCCC at Johns Hopkins — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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