Completed

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

What is being tested

18F-DCFBC

Drug

Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

From 18 to 100 Years

+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Diagnostic Study

Phase 1 & 2

Interventional

Study Start: March 2013

See protocol details

Summary

Principal SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last updated: August 20, 2018

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Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01815515

Principal SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last updated: August 20, 2018

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

22 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesUrogenital NeoplasmsMale Urogenital DiseasesProstatic Neoplasms

Criteria

8 inclusion criteria required to participate

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

Histological confirmation of prostate cancer

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

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

Show More Criteria

8 exclusion criteria prevent from participating

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

Liver Transaminases > 5times the upper limit of normal

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

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Johns Hopkins University

Baltimore, United StatesOpen Johns Hopkins University in Google Maps

CompletedOne Study Center