Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer

NCT ID: NCT01815515

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-11-18

Brief Summary

This research is being done to see if an investigational radioactive drug called 18F-DCFBC can help us find cancer that has spread (metastatic disease) from its original site in people who have cancer in their prostate to other parts of their body.

Detailed Description

The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), [18F]DCFBC (DCFBC) PET imaging for detection of metastatic prostate cancer. PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential. The investigators propose to assess the ability of DCFBC PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis. Correlation will be made to sites of suspected metastatic disease detected by standard conventional imaging modalities (CIM) for prostate cancer which includes IV contrast CT of chest/abdomen/pelvis and whole body bone scintigraphy.

Conditions

Metastatic Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18F-DCFBC

Participants with hormone-naive prostate cancer (HNPC) and castration-resistant prostate cancer (CRPC) with metastatic lesions detected on conventional imaging modalities (contrast-enhanced computed tomography \[CECT\] and bone scintigraphy \[BS\]) undergo PET imaging with 18F-DCFBC radiotracer.

Group Type: EXPERIMENTAL

18F-DCFBC

Intervention Type: DRUG

18F-DCFBC is a radiofluorinated small-molecule inhibitor of prostate-specific membrane antigen (PSMA).

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.

Interventions

18F-DCFBC

18F-DCFBC is a radiofluorinated small-molecule inhibitor of prostate-specific membrane antigen (PSMA).

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.

Intervention Type: DRUG

Other Intervention Names

N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-18F-fluorobenzyl-L-cysteine

Eligibility Criteria

Inclusion Criteria

1. Histological confirmation of prostate cancer

2. Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, [18F]Sodium Fluoride PET, and/or [18F]FDG PET

3. Rising PSA on two observations taken at least 1 week apart

4. Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration

5. Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease

6. Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging

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. Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration

2. Prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest)

3. Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression.

4. Serum creatinine > 3 times the upper limit of normal

5. Total bilirubin > 3 times the upper limit of normal

6. Liver Transaminases > 5times the upper limit of normal

7. Unable to lie flat during or tolerate PET/CT

8. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zsolt Szabo, M.D

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00052383

Identifier Type: OTHER

Identifier Source: secondary_id

J12113

Identifier Type: -

Identifier Source: org_study_id