NCT03861676 · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Image-guided Focal Brachytherapy Utilizing Combined 18F-DCFPyl PET/CT
What this study is about
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.
View original scientific 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.
Interventions
RADIATION
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.
DRUG
(18F)DCFPyL
18F-DCFPyl PET/CT scan
Primary outcome measures
Percent tumor coverage
Time frame: Post-implant Day 30
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Baltimore, Maryland
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 13, 2026 · Source of record for eligibility and locations