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
About This Trial
- This study is testing whether advanced imaging scans can help doctors deliver targeted internal radiation directly to prostate tumors while avoiding healthy tissue.
- By treating only the cancer rather than the entire prostate gland, researchers hope to successfully control the disease while reducing unwanted side effects.
- The trial is open to men with early-stage prostate cancer that has not spread outside the prostate.
- Before taking part, patients should know that the study requires multiple imaging scans, meaning individuals with certain metal implants or severe claustrophobia may not be eligible to participate.
More Information
- 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 Enroll
- Age Range: 18 - 100 years
- Gender: Male
- Who This Trial is For: This study is testing whether advanced imaging scans can help doctors deliver targeted internal radiation directly to prostate tumors while avoiding healthy tissue.
Study Details
- Start Date: August 3, 2023
- Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Full 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
Treatments
- Radiation: Focal brachytherapy with PSMA PET imaging
- Drug: (18F)DCFPyL