NCT03861676RecruitingEarly phase 1
Image-guided Focal Brachytherapy Utilizing Combined 18F-DCFPyl PET/CT
Image-guided Focal Brachytherapy Utilizing Combined 18F-DCFPyl PET/CT and Dynamic Dosimetry With Registered Ultrasound and Fluoroscopy for Localized Prostate Cancer
Source: ClinicalTrials.gov · Last updated 13 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 1 Mar 2019
- Start date
- 3 Aug 2023
- Primary completion date
- Dec 2028
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Prostate cancer
- NCT number
- NCT03861676
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 20
- From 3 Aug 2023 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of pelvic radiation therapy
- Metallic implants, claustrophobia not amenable to medication, or known contraindications to undergoing MR scanning
Other illness
- Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.
- History of other malignancy diagnosed within the past 3 years
Other
- Implanted device or apparatus which obstruct visibility of the implanted sources on fluoroscopy
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SKCCC at Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.