RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Image-guided Focal Brachytherapy Utilizing Combined 18F-DCFPyl PET/CT and Dynamic Dosimetry With Registered Ultrasound and Fluoroscopy for Localized Prostate Cancer

Quick Facts

Study Start:2023-08-03
Study Completion:2033-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03861676

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adenocarcinoma of the prostate
  2. * Performance Status \< 2
  3. * Clinical stages (not radiographic stage) T1c - T2a, Nx or N0, Mx or M0
  4. * Gleason 6-7 cancer
  5. * Prostate volume \< 60 cc (if MRI and TRUS have conflicting values, then MRI value will be utilized)
  6. * International Prostate symptom score (IPSS) 20 or less
  7. * Ability to undergo DCF-Pyl PSMA PET as part of pretreatment staging
  8. * Signed study-specific consent form prior to registration
  1. * Prior history of pelvic radiation therapy
  2. * Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.
  3. * Implanted device or apparatus which obstruct visibility of the implanted sources on fluoroscopy
  4. * Metallic implants, claustrophobia not amenable to medication, or known contraindications to undergoing MR scanning
  5. * History of other malignancy diagnosed within the past 3 years

Contacts and Locations

Study Contact

Daniel Song, MD
CONTACT
(410) 502-5875
dsong2@jhmi.edu
Dana Kaplin
CONTACT
(410) 614-3950
dkaplin1@jhmi.edu

Principal Investigator

Daniel Song, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

SKCCC at Johns Hopkins
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  • Daniel Song, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-03
Study Completion Date2033-12

Study Record Updates

Study Start Date2023-08-03
Study Completion Date2033-12

Terms related to this study

Keywords Provided by Researchers

  • focal therapy
  • brachytherapy
  • PSMA
  • DCF-Pyl

Additional Relevant MeSH Terms

  • Prostate Cancer