18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment
Status: | Completed |
---|---|
Conditions: | Prostate Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/30/2019 |
Start Date: | June 1, 2016 |
End Date: | November 1, 2017 |
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
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.
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.
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
We found this trial at
17
sites
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1500 East Duarte Road
Duarte, California 91010
Duarte, California 91010
626-256-HOPE (4673)
Phone: 626-256-4673
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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University of Louisville The University of Louisville is a state supported research university located in...
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2160 South 1st Avenue
Maywood, Illinois 60153
Maywood, Illinois 60153
(888) 584-7888
Phone: 708-327-2237
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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1428 Madison Ave
New York, New York 10029
New York, New York 10029
(212) 241-6500
Phone: 212-241-9369
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-746-8192
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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111 S 11th St
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-955-4129
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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