18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment (LOCATE)
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|ClinicalTrials.gov Identifier: NCT02680041|
Recruitment Status : Completed
First Posted : February 11, 2016
Results First Posted : January 28, 2019
Last Update Posted : January 28, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: 18F-fluciclovine PET CT||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||221 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 1, 2016|
|Actual Primary Completion Date :||November 1, 2017|
|Actual Study Completion Date :||November 1, 2017|
Experimental: 18F-fluciclovine PET CT
Single intravenous administration of 18F-fluciclovine PET CT.
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
Other Name: FACBC
- The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease. [ Time Frame: 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
- The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02680041
|Study Chair:||Umar Mahmood, MD, PhD||Harvard Medical School (HMS and HSDM)|
|Study Director:||Peter Gardiner, MB ChB, MRCP, FFPM||Blue Earth Diagnostics|
Documents provided by Blue Earth Diagnostics:
|Responsible Party:||Blue Earth Diagnostics|
|Other Study ID Numbers:||
|First Posted:||February 11, 2016 Key Record Dates|
|Results First Posted:||January 28, 2019|
|Last Update Posted:||January 28, 2019|
|Last Verified:||January 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Male Urogenital Diseases