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18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment

NCT02680041 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2019-01-28

Study results available
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Summary

This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent prostate cancer after curative-intent primary therapy and negative or equivocal findings on standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine PET/CT. Site clinicians will manage study subjects per standard practices and will document any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants will be followed for up to 6 months, with clinical data collected for this study. An interdisciplinary panel will provide expert guidance to local readers on request. The final reporting of the PET/CT scan will be a single report by the local reader following any such discussion.

Conditions

Interventions

DRUG

18F-fluciclovine PET CT

Subjects will undergo a fluciclovine F18 PET/CT scan in addition to standard of care monitoring. The results of this scan may influence further treatment

Sponsors & Collaborators

  • American College of Radiology

    collaborator OTHER

  • IND 2 Results LLC

    collaborator INDUSTRY

  • Syne Qua Non Limited

    collaborator INDUSTRY

  • Blue Earth Diagnostics

    lead INDUSTRY

Principal Investigators

  • Umar Mahmood, MD, PhD · Harvard Medical School (HMS and HSDM)

  • Peter Gardiner, MB ChB, MRCP, FFPM · Blue Earth Diagnostics

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2017-11-01
Completion
2017-11-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02680041 on ClinicalTrials.gov