NCT03861676

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P50-P75 for early_phase_1 prostate-cancer

Timeline
92mo left

Started Aug 2023

Longer than P75 for early_phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Aug 2023Dec 2033

First Submitted

Initial submission to the registry

March 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
4.4 years until next milestone

Study Start

First participant enrolled

August 3, 2023

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2033

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

5.3 years

First QC Date

March 1, 2019

Last Update Submit

February 11, 2026

Conditions

Prostate Cancer

Keywords

focal therapybrachytherapyPSMADCF-Pyl

Outcome Measures

Primary Outcomes (1)

  • Percent tumor coverage

    Percent coverage of the combined PET-MR based tumor volume achieved when using iRUF intraoperative dosimetry. PET-MR tumor volume D90 will be defined on pre-treatment PET-MR fusion, and dose from seeds will be calculated on post-implant MR/CT (Day \~30); the two volumes will be co-registered to determine tumor volume coverage.

    Post-implant Day 30

Study Arms (1)

Focal brachytherapy

EXPERIMENTAL

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

Radiation: Focal brachytherapy with PSMA PET imagingDrug: (18F)DCFPyL

Interventions

(18F)DCFPyLDRUG

18F-DCFPyl PET/CT scan

Also known as: PSMA, PET
Focal brachytherapy
Focal brachytherapy with PSMA PET imagingRADIATION

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.

Also known as: Prostate seed implant, Radiotherapy, Radiation, Focal therapy
Focal brachytherapy

Eligibility Criteria

Age18 Years - 100 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SKCCC at Johns Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

RadiotherapyRadiation2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Phenomena

Study Officials

  • Daniel Song, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Song, MD

CONTACT

(410) 502-5875dsong2@jhmi.edu

Dana Kaplin

CONTACT

(410) 614-3950dkaplin1@jhmi.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-arm
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2019

First Posted

March 4, 2019

Study Start

August 3, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2033

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)