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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT03861676
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Focal brachytherapy with PSMA PET imaging — RADIATION
    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.
  • (18F)DCFPyL — DRUG
    18F-DCFPyl PET/CT scan

Study Details

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 Dates

Start date
Aug 3, 2023
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2033

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Focal brachytherapy
    Drug: 18F-DCFPyl Other names: PET, PSMA Procedure: Focal brachytherapy with PSMA PET imaging Other names: Radiotherapy, Radiation, Prostate seed implant, Focal therapy

Primary Outcome Measure

Percent tumor coverage [ Time Frame: Post-implant Day 30 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
SKCCC at Johns HopkinsBaltimoreMaryland21287
Daniel Song, M.D.
[email protected]
410-502-5875
Dana B Kaplin, MPH
[email protected]
410-502-3595
Junghoon Lee, PhD (SUB_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
SKCCC at Johns Hopkins· Baltimore, MD

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