Recruiting
Early Phase 1

Focal Brachytherapy

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT03861676

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Focal brachytherapy with PSMA PET imaging

(18F)DCFPyL

Study Details

Brief summary:

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 ID

NCT03861676

Start date

Aug 3, 2023

Status verified date

Feb, 2026

Completion date

Dec, 2033

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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.

(18F)DCFPyL

18F-DCFPyl PET/CT scan

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Daniel Song, MD

(410) 502-5875dsong2@jhmi.edu

Dana Kaplin

(410) 614-3950dkaplin1@jhmi.edu

Locations

SKCCC at Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Daniel Song, M.D.

410-502-5875dsong2@jhmi.edu

Dana B Kaplin, MPH

410-502-3595dkaplin1@jhmi.edu

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Keywords

  • focal therapy
  • brachytherapy
  • PSMA
  • DCF-Pyl

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2026-02-13.