A Phase II Study to Evaluate Axumin PET/CT for Risk Stratification for Prostate Cancer

Launched by HALO DIAGNOSTICS · Dec 12, 2017

Keywords

ClinConnect Summary

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 upregulated in prostate cancer cells. Fluciclovine F 18 is taken up to a greater extent in prostate cancer cells compared with surrounding normal tissues.

Pharmacodynamics:

Following intravenous administration, the tumor-to-normal tissue contrast is highest between 4 and 10 minutes after injection, with a 61% reduction in mean tumor uptake at 90 minutes after injection.

Pharmacokinetics:

Distribu...

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Male, 45 years of age or older.
• • 2. Diagnosis of prostate adenocarcinoma.
• • 3. Clinical stage T1a, T1b, T1c, T2a, T2b orT2c.
• • 4. Gleason score of 7 (3+4 or 4+3).
• • 5. PSA density less than 0.375.
• • 6. One, two, or three tumor suspicious regions identified on multiparametric MRI.
• • 7. Negative radiographic indication of extra-capsular extent.
• • 8. Karnofsky performance status of at least 70.
• • 9. Estimated survival of 5 years or greater, as determined by treating physician.
• • 10. Tolerance for anesthesia/sedation.
• • 11. Ability to give informed consent.
• Exclusion Criteria:
• • 1. Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
• • 2. 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)
• • 3. History of other Primary non-skin malignancy within previous three years.
• • 4. Diabetes.
• • 5. Smoker.