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

NCT ID: NCT02680041

Last Updated: 2019-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2017-11-01

Brief 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

Prostate Cancer

Study Design

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

Study Groups

18F-fluciclovine PET CT

Single intravenous administration of 18F-fluciclovine PET CT.

Group Type: EXPERIMENTAL

18F-fluciclovine PET CT

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

FACBC

Eligibility Criteria

Inclusion Criteria

• History of histologically confirmed adenocarcinoma of the prostate post curative-intent local treatment (radical prostatectomy, local radiotherapy, brachytherapy).
• Suspicion of recurrent prostate carcinoma after previous presumed definitive therapy for organ confined disease defined as :
• Post prostatectomy: Detectable or rising PSA level that is >0.2 ng/mL with a second confirmatory level of >0.2 ng/mL
• Post non-prostatectomy: PSA rise ≥ 2ng/mL over nadir
• Negative or equivocal findings on standard-of-care imaging for restaging of disease in the previous 60 days consisting of: Whole-body 99mTc bone scintigraphy or NaF PET-CT; and either CT or MRI of the pelvis (or the abdomen and pelvis).
• Being considered for salvage therapy
• Any non-surgical local treatment such as previous cryotherapy, external beam radiation, or HiFU (Ultrasound) must have occurred at least 1 year in the past.
• Previous brachytherapy treatment will have occurred at least 2 years in the past
• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria

• Ongoing treatment with any systemic therapy intended for the treatment of prostate cancer (e.g., antiandrogen or LHRH agonist or antagonist)
• Androgen deprivation therapy (ADT) in the past 3 months
• History of bilateral orchidectomy
• Inability to tolerate 18F-fluciclovine PET/CT

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

Sponsors

American College of Radiology

OTHER

Sponsor Role: collaborator

IND 2 Results LLC

INDUSTRY

Sponsor Role: collaborator

Syne Qua Non Limited

INDUSTRY

Sponsor Role: collaborator

Blue Earth Diagnostics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Umar Mahmood, MD, PhD

Role: STUDY_CHAIR

Harvard Medical School (HMS and HSDM)

Peter Gardiner, MB ChB, MRCP, FFPM

Role: STUDY_DIRECTOR

Blue Earth Diagnostics

Locations

City of Hope National Medical Center

Duarte, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Tower Urology

Los Angeles, California, United States

Genesis Research, LLC

San Diego, California, United States

University of Florida

Jacksonville, Florida, United States

Loyola University Medical Center

Maywood, Illinois, United States

Roudebush VA Medical Center

Indianapolis, Indiana, United States

University of Louisville

Louisville, Kentucky, United States

Washington University School of Medicine

St Louis, Missouri, United States

Coastal Urology Associates

Brick, New Jersey, United States

Manhattan Medical Research

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Urologic Consultants of SE Pennsylvania

Bala-Cynwyd, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

University of Utah, Huntsman Cancer Institute

Salt Lake City, Utah, United States

Countries

United States

References

Andriole GL, Scarsbrook AF, Savir-Baruch B; LOCATE/FALCON Study Groups. Impact of 18F-fluciclovine PET/CT on plans for androgen deprivation therapy in patients with biochemical recurrence of prostate cancer: data analysis from two prospective clinical trials. Urol Oncol. 2023 Jun;41(6):293.e1-293.e7. doi: 10.1016/j.urolonc.2023.04.004. Epub 2023 Apr 29.

Reference Type: DERIVED

PMID: 37121865 (View on PubMed)

Savir-Baruch B, Lovrec P, Solanki AA, Adams WH, Yonover PM, Gupta G, Schuster DM. Fluorine-18-Labeled Fluciclovine PET/CT in Clinical Practice: Factors Affecting the Rate of Detection of Recurrent Prostate Cancer. AJR Am J Roentgenol. 2019 Oct;213(4):851-858. doi: 10.2214/AJR.19.21153. Epub 2019 Jun 19.

Reference Type: DERIVED

PMID: 31216198 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BED003

Identifier Type: -

Identifier Source: org_study_id