Status:
COMPLETED
A Phase II Study to Evaluate Axumin PET/CT for Risk Stratification for Prostate Cancer
Lead Sponsor:
HALO Diagnostics
Conditions:
Prostate Cancer
Eligibility:
MALE
45+ years
Phase:
PHASE2
Brief Summary
To investigate the utility of fluciclovine F 18 for evaluation for metastatic disease in men undergoing laser focal therapy of prostate cancer and the impact on inclusion for a focal therapy cohort.
Detailed Description
DESCRIPTION OF DRUG Mechanism of action: Fluciclovine F 18 is a synthetic amino acid transported across mammalian cell membranes by amino acid transporters, such as LAT-1 and ASCT2, which are upregu...
Eligibility Criteria
Inclusion
- Male, 45 years of age or older.
- Diagnosis of prostate adenocarcinoma.
- Clinical stage T1a, T1b, T1c, T2a, T2b orT2c.
- Gleason score of 7 (3+4 or 4+3).
- PSA density less than 0.375.
- One, two, or three tumor suspicious regions identified on multiparametric MRI.
- Negative radiographic indication of extra-capsular extent.
- Karnofsky performance status of at least 70.
- Estimated survival of 5 years or greater, as determined by treating physician.
- Tolerance for anesthesia/sedation.
- Ability to give informed consent.
Exclusion
- Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
- Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater. ( (http://www.urospec.com/uro/Forms/ipss.pdf)
- History of other Primary non-skin malignancy within previous three years.
- Diabetes.
- Smoker.
Key Trial Info
Start Date :
February 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03373006
Start Date
February 27 2018
End Date
January 30 2020
Last Update
May 25 2022
Active Locations (1)
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1
Desert Medical Imaging
Indian Wells, California, United States, 92210