Prostate Cancer Clinical Trial
Evaluation of Prostate-specific Membrane Antigen (PSMA)-Based PET Imaging of Primary Prostate Cancer
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 cancer detection and aggressiveness at initial diagnosis. PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness but a quantitative non-invasive method for PSMA detection and monitoring is not currently available. Development of such an imaging biomarker would be useful to differentiate indolent from aggressive prostate cancer phenotypes and allow for selection of appropriate risk adaptive therapies. The investigators preliminary first-in-human studies demonstrate high specific DCFBC uptake in metastatic prostate cancer and feasibility for prostate cancer imaging. The investigators propose to study patients initially diagnosed with biopsy-positive prostate cancer to determine if DCFBC uptake and location by PET imaging will be positively correlated with prostate cancer by prostatectomy tissue step-section analysis. DCFBC uptake at sites of suspected metastatic disease will be compared to conventional imaging modalities (CT, bone scan) and biopsy results when available. In addition, DCFBC-PET uptake quantification will be compared with expression levels of PSMA and other prostate cancer relevant markers (PSA, Ki-67, TMPRSS2-ERG) by prostate tissue immunohistochemistry analysis and compared with clinical prognostic markers (PSA, Gleason score, clinical stage, Partin tables derived prediction of pathologic stage).
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Baltimore Maryland, 21287, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.