Status:
COMPLETED
PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Prostate Cancer
Prostate Neoplasm
Eligibility:
MALE
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The overall goal of this research is to validate and develop a non-invasive imaging biomarker of prostate cancer detection, progression, and recurrence. Development of such a biomarker may be useful t...
Detailed Description
The investigators propose to evaluate a novel second-generation low-molecular-weight prostate specific membrane antigen (PSMA)-based positron emission tomography (PET) agent, 18F-DCFPyL, for detection...
Eligibility Criteria
Inclusion
- Prostate cancer pathologically proven by prostate biopsy (newly diagnosed for Sub-Study 1 and 4)
- Prostate biopsy histology grade ≥ Gleason 1, 6, 3+4, or 4+3; positive biopsy \>2 cores
- Any PSA permitted
- Two consecutive rising PSA values (Sub-Study 3 only)
- Castrate-levels of testosterone - total testosterone \< 50 ng/dL (Sub-Study 3 only)
- Patients considered as candidates for and medically fit to undergo prostatectomy
- At least 7 days after most recent prostate biopsy
- Imaging evidence of suspected metastatic disease, including CT, bone scan, MRI, ultrasound or other PET modalities (Sub-Study 3 only)
- New diagnosis of prostate cancer undergoing additional biopsy evaluation (Sub--Study 4 only)
- Karnofsky performance status of at least 70 (Sub-Study 4 only)
- General health and anatomy suitable to undergo transrectal ultrasound-MRI fusion biopsy of the identified lesions and standard 12 core sextent biopsy (Sub-Study 4 only)
Exclusion
- Prior pelvic external beam radiation therapy or brachytherapy
- Chemotherapy for prostate cancer
- Androgen deprivation therapy for prostate cancer
- Investigational therapy for prostate cancer (Sub-Study 3 Only)
- Unable to lie flat during or tolerate PET/CT
- Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
- No prostatectomy scheduled more than 12 hours post imaging (Sub-Study 1 only)
- Serum creatinine \> 2 time the upper limit of normal
- Total bilirubin \> 3 times the upper limit of normal
- Liver Transaminases \> 5 times the upper limit of normal
Key Trial Info
Start Date :
February 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2024
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT03232164
Start Date
February 2 2017
End Date
November 1 2024
Last Update
December 12 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792