Actively Recruiting

Early Phase 1
Age: 18Years - 100Years
MALE
NCT03861676

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

Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-02-13

20

Participants Needed

1

Research Sites

539 weeks

Total Duration

On this page

Sponsors

S

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 100Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of adenocarcinoma of the prostate
  • Performance status less than 2
  • Clinical stage T1c to T2a, Nx or N0, Mx or M0
  • Gleason score 6 to 7 cancer
  • Prostate volume under 60 cc (MRI value used if MRI and ultrasound differ)
  • International Prostate Symptom Score (IPSS) of 20 or less
  • Ability to undergo 18F-DCFPyl PSMA PET scan before treatment
  • Signed consent form specific to this study before registration
Not Eligible

You will not qualify if you...

  • Prior pelvic radiation therapy
  • Major medical or psychiatric illness that would prevent completing treatment or interfere with follow-up
  • Implanted device blocking fluoroscopy visibility of implanted seeds
  • Metallic implants, claustrophobia not manageable with medication, or contraindications to MRI
  • History of other cancer diagnosed within the past 3 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

SKCCC at Johns Hopkins

Baltimore, Maryland, United States, 21287

Actively Recruiting

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Research Team

D

Daniel Song, MD

CONTACT

D

Dana Kaplin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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