Clinical trial NCT02680041: 18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Blue Earth Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: American College of Radiology
name: IND 2 Results LLC
name: Syne Qua Non Limited
First posted: 2016-02-11
Enrollment: 221
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease.
timeFrame: 2-22 days post PET CT
Secondary outcomes:
measure: The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment
timeFrame: 6 months
measure: The Rate of Detection of Any Disease Site by 18F-fluciclovine PET/CT in the Study Population
timeFrame: 1 week
measure: 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
timeFrame: 1 week
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Tower Urology
state: California
city: San Diego
country: United States
facility: Genesis Research, LLC
state: California
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Roudebush VA Medical Center
state: Indiana
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Brick
country: United States
facility: Coastal Urology Associates
state: New Jersey
city: New York
country: United States
facility: Manhattan Medical Research
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of SE Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah, Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Umar Mahmood, MD, PhD
role: STUDY_CHAIR
affiliation: Blue Earth Diagnostics
name: Peter Gardiner, MB ChB, MRCP, FFPM
role: STUDY_DIRECTOR
References:
citation: 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.