Status:
RECRUITING
Image-guided Focal Brachytherapy Utilizing Combined 18F-DCFPyl PET/CT
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18-100 years
Phase:
EARLY_PHASE1
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 brac...
Detailed Description
Current conventional prostate cancer (PCa) imaging modalities (computed tomography, bone scan, magnetic resonance imaging, ultrasound) have limited accuracy in the initial staging and for determining ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2033
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03861676
Start Date
August 3 2023
End Date
December 1 2033
Last Update
January 10 2025
Active Locations (1)
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1
SKCCC at Johns Hopkins
Baltimore, Maryland, United States, 21287