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

NCT02680041 | Completed Phase 3 Results

• 1 other identifier: BED003
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 17

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

Outcome Measures

Primary Outcomes (1)

• The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease.

  The change of management will be based on referring physician questionnaires completed pre- and post- 18F-fluciclovine PET/CT

  2-22 days post PET CT

Secondary Outcomes (5)

• The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment

  6 months

• The Rate of Detection of Any Disease Site by 18F-fluciclovine PET/CT in the Study Population

  1 week

• The Rate of Detection of Disease in 1) Prostate and Prostate Bed and 2) Extra-prostatic Regions With 18F-fluciclovine PET/CT in the Study Population

  1 week

• The Positive Predictive Value (PPV) of 18F-fluciclovine PET/CT for Regional Disease Compared to Biopsy in Those Patients Who Undergo Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy

  6 months

• The PPV of 18F-fluciclovine PET/CT for Distant Disease Compared to Biopsy in Those Patients Who Undergo a Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy

  6 months

Study Arms (1)

18F-fluciclovine PET CT

EXPERIMENTAL

Single intravenous administration of 18F-fluciclovine PET CT.

Drug: 18F-fluciclovine PET CT

Interventions

18F-fluciclovine PET CT 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

Also known as: FACBC

18F-fluciclovine PET CT

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Blue Earth Diagnostics: lead
• American College of Radiology: collaborator
• IND 2 Results LLC: collaborator
• Syne Qua Non Limited: collaborator

Study Sites (17)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Tower Urology

Los Angeles, California, 90048, United States

Location

Genesis Research, LLC

San Diego, California, 92123, United States

Location

University of Florida

Jacksonville, Florida, 32209, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Roudebush VA Medical Center

Indianapolis, Indiana, 46202, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Coastal Urology Associates

Brick, New Jersey, 08724, United States

Location

Manhattan Medical Research

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Urologic Consultants of SE Pennsylvania

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Utah, Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (2)

• 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.

  PMID: 37121865 DERIVED

• 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.

  PMID: 31216198 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

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: Peter Gardiner MB ChB, MRCP, FFPM
• Organization: Blue Earth Diagnostics, Ltd.

P.Gardiner@blueearthDx.com

1-781-552-3403

Study Officials

• Umar Mahmood, MD, PhD

  Harvard Medical School (HMS and HSDM)

  STUDY CHAIR

• Peter Gardiner, MB ChB, MRCP, FFPM

  Blue Earth Diagnostics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: February 11, 2016
• Study Start: June 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 28, 2019
• Results First Posted: January 28, 2019

Record last verified: 2019-01

Locations

US (17)