Status:
COMPLETED
Evaluation of Prostate-specific Membrane Antigen (PSMA)-Based PET Imaging of Primary Prostate Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Prostate Cancer
Eligibility:
MALE
18-90 years
Phase:
PHASE1
PHASE2
Brief Summary
The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), \[18F\]DCFBC (DCFBC), as a PET imaging biomarker of prostate...
Eligibility Criteria
Inclusion
- Newly diagnosed prostate cancer pathologically proven by prostate biopsy
- Prostate biopsy histology grade ≥ Gleason 3+3=6.
- Patients considered as candidates for and medically fit to undergo prostatectomy
- At least 10 days after most recent prostate biopsy
- No known problems with peripheral IV or central line access
- Able to tolerate urinary straight catheter placement
- Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits.
- Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.
Exclusion
- Prior pelvic external beam radiation therapy or brachytherapy
- Chemotherapy for prostate cancer
- Hormone deprivation therapy
- Investigational therapy for prostate cancer
- Hemorrhagic cystitis or active prostatitis
- 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 prior to follow-up visit (12 to 72 hours post imaging)
- Serum creatinine \> 1.5 mg/dL or creatinine clearance \< 50 mL/min/1.73m2
Key Trial Info
Start Date :
September 11 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01496157
Start Date
September 11 2012
End Date
September 17 2017
Last Update
August 28 2018
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287