18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment
- Conditions
- Prostate Cancer
- Interventions
- Drug: 18F-fluciclovine PET CT
- Registration Number
- NCT02680041
- Lead Sponsor
- Blue Earth Diagnostics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 221
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 18F-fluciclovine PET CT 18F-fluciclovine PET CT Single intravenous administration of 18F-fluciclovine PET CT.
- Primary Outcome Measures
Name Time Method The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease. 2-22 days post PET CT The change of management will be based on referring physician questionnaires completed pre- and post- 18F-fluciclovine PET/CT
- Secondary Outcome Measures
Name Time Method The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment 6 months 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.The Rate of Detection of Any Disease Site by 18F-fluciclovine PET/CT in the Study Population 1 week The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT
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 percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT 1) in the pelvis and 2) distally
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 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
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 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
Trial Locations
- Locations (17)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Manhattan Medical Research
🇺🇸New York, New York, United States
Tower Urology
🇺🇸Los Angeles, California, United States
Roudebush VA Medical Center
🇺🇸Indianapolis, Indiana, United States
Urologic Consultants of SE Pennsylvania
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
University of Florida
🇺🇸Jacksonville, Florida, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Coastal Urology Associates
🇺🇸Brick, New Jersey, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Genesis Research, LLC
🇺🇸San Diego, California, United States
University of Utah, Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States