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

NCT01815515 | Completed Phase 1 Results

• 2 other identifiers: J12113NA_00052383
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Prostate Cancer

Keywords

Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM)

  Measurement of sensitivity of DCFBC PET to CIM (contrast-enhanced CT and bone scintigraphy) for detection of metastatic prostate cancer based on number of lesions that are detected on PET/CT, in agreement with CT and CIM. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive.

  24 Months

Secondary Outcomes (1)

• Sensitivity of Detection of New or Progression of Metastasis

  up to 1 year

Study Arms (1)

18F-DCFBC

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.

Drug: 18F-DCFBC

Interventions

18F-DCFBC 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.

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

18F-DCFBC

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological confirmation of prostate cancer
• 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
• Rising PSA on two observations taken at least 1 week apart
• Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration
• 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
• 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:

• Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
• 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)
• Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression.
• Serum creatinine \> 3 times the upper limit of normal
• Total bilirubin \> 3 times the upper limit of normal
• Liver Transaminases \> 5times the upper limit of normal
• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

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

• Zsolt Szabo, M.D

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: March 18, 2013
• First Posted: March 21, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: November 18, 2015
• Last Updated: August 20, 2018
• Results First Posted: August 20, 2018

Record last verified: 2018-08

Locations

US (1)