Clinical trial NCT01496157: Evaluation of Prostate-specific Membrane Antigen (PSMA)-Based PET Imaging of Primary Prostate Cancer
Official title: Evaluation of PSMA-based PET as an Imaging Biomarker of Primary Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Primary Prostate Cancer
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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:

1. Newly diagnosed prostate cancer pathologically proven by prostate biopsy
2. Prostate biopsy histology grade ≥ Gleason 3+3=6.
3. Patients considered as candidates for and medically fit to undergo prostatectomy
4. At least 10 days after most recent prostate biopsy
5. No known problems with peripheral IV or central line access
6. Able to tolerate urinary straight catheter placement
7. 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.
8. 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:

1. Prior pelvic external beam radiation therapy or brachytherapy
2. Chemotherapy for prostate cancer
3. Hormone deprivation therapy
4. Investigational therapy for prostate cancer
5. Hemorrhagic cystitis or active prostatitis
6. Unable to lie flat during or tolerate PET/CT
7. 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
8. No prostatectomy scheduled prior to follow-up visit (12 to 72 hours post imaging)
9. Serum creatinine \> 1.5 mg/dL or creatinine clearance \< 50 mL/min/1.73m2

Primary outcomes:
measure: PET Detection of Primary Prostate Cancer
timeFrame: 24 months
Secondary outcomes:
measure: PET Detection of Metastatic Disease at Initial Staging
timeFrame: 24 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Steven P Rowe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rowe SP, Gage KL, Faraj SF, Macura KJ, Cornish TC, Gonzalez-Roibon N, Guner G, Munari E, Partin AW, Pavlovich CP, Han M, Carter HB, Bivalacqua TJ, Blackford A, Holt D, Dannals RF, Netto GJ, Lodge MA, Mease RC, Pomper MG, Cho SY. (1)(8)F-DCFBC PET/CT for PSMA-Based Detection and Characterization of Primary Prostate Cancer. J Nucl Med. 2015 Jul;56(7):1003-1010. doi: 10.2967/jnumed.115.154336. Epub 2015 Jun 11.