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

Prostate Cancer Clinical Trial

— LOCATE  

Official title:

The Impact of 18F Fluciclovine (FACBC) PET/CT (Positron Emission Computed Tomography) on Management of Patients With Rising PSA (Prostate-specific Antigen) After Initial Prostate Cancer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02680041
• Other study ID #: BED003
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2016
• Est. completion date: November 1, 2017

Study information

• Verified date: January 2019
• Source: Blue Earth Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Urologic Consultants of SE Pennsylvania	Bala-Cynwyd	Pennsylvania
United States	Coastal Urology Associates	Brick	New Jersey
United States	City of Hope National Medical Center	Duarte	California
United States	Roudebush VA Medical Center	Indianapolis	Indiana
United States	University of Florida	Jacksonville	Florida
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Tower Urology	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	Loyola University Medical Center	Maywood	Illinois
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Manhattan Medical Research	New York	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Utah, Huntsman Cancer Institute	Salt Lake City	Utah
United States	Genesis Research, LLC	San Diego	California

Sponsors (4)

Lead Sponsor	Collaborator
Blue Earth Diagnostics	American College of Radiology, IND 2 Results LLC, Syne Qua Non Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment	The change of management will be based on referring physician questionnaires completed pre- 18F-fluciclovine PET/CT and changes reported at 6 month follow-up.; Investigators were instructed to assess any clinically significant change from the revised management plan.	6 months
Secondary	The Rate of Detection of Any Disease Site by 18F-fluciclovine PET/CT in the Study Population	The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT	1 week
Secondary	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	The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT 1) in the pelvis and 2) distally	1 week
Secondary	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	Based on the ratio of positive findings in the pelvis on 18F-fluciclovine PET/CT which are confirmed by histological examination of tissue or MRI	6 months
Secondary	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	Based on the ratio of positive findings outside the pelvis on 18F-fluciclovine PET/CT which are confirmed by histological examination of tissue or MRI	6 months