Evaluation of Prostate-specific Membrane Antigen (PSMA)-Based PET Imaging of Primary Prostate Cancer

NCT01496157 | Completed Phase 1 Results DMC

• 2 other identifiers: J1191NA_00051395
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer

Keywords

Primary Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• PET Detection of Primary Prostate Cancer

  To compare number of participants with positive or negative uptake of 18F-DCFBC in primary prostate cancer by DCFBC PET to prostatectomy pathology as determined by tissue step-section analysis in men with biopsy-positive prostate cancer (Gleason score \> 4+3=7).

  24 months

Secondary Outcomes (1)

• PET Detection of Metastatic Disease at Initial Staging

  24 months

Study Arms (1)

Patients with Primary Prostate Cancer

EXPERIMENTAL

Patients will be imaged with 18F-DCFBC

Drug: 18F-DCFBC

Interventions

18F-DCFBC DRUG

A bolus of 10 mCi (370 MBq) \[9-11 mCi (333-407 MBq)\] of 18F-DCFBC will be injected into the IV line by slow IV push.

Patients with Primary Prostate Cancer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• 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.

  PMID: 26069305 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

N-(N-((S)-1,3-Dicarboxypropyl)carbamoyl)-4-(18F)fluorobenzyl-L-cysteine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Steven Rowe, M.D, Ph.D
• Organization: Johns Hopkins University

srowe8@jhmi.edu

4105021520

Study Officials

• Steven P Rowe, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 21, 2011
• Study Start: September 11, 2012
• Primary Completion: January 1, 2015
• Study Completion: September 17, 2017
• Last Updated: August 28, 2018
• Results First Posted: August 28, 2018

Record last verified: 2018-07

Locations

US (1)