NCT03861676 Image-guided Focal Brachytherapy Utilizing Combined 18F-DCFPyl PET/CT
| NCT ID | NCT03861676 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-08-03 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2023-08-03 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Daniel Song, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT03861676 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 100 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03861676 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03861676 currently recruiting?
Yes, NCT03861676 is actively recruiting participants. Contact the research team at dsong2@jhmi.edu for enrollment information.
Where is the NCT03861676 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT03861676 clinical trial?
NCT03861676 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The principal investigator is Daniel Song, MD at Johns Hopkins University. The trial plans to enroll 20 participants.
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