Image-guided Focal Brachytherapy Utilizing Combined 18F-DCFPyl PET/CT
Recruiting · NCT03861676 · Interventional (participants receive a specific treatment) · Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
View the official record on ClinicalTrials.gov →Interventions studied
(18F)DCFPyLFocal brachytherapy with PSMA PET imaging
What this trial 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. 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.
Who can take part
Age range
18 Years to 100 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- SKCCC at Johns Hopkins - Baltimore, Maryland, United States