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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT03373006

Run by

HALO Diagnostics

People needed

20

Starts

2018-02-27

Expected to finish

2020-01-30

Last updated by the study team

2022-05-25

Who can join

Age: 45 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Desert Medical Imaging — Indian Wells, California, United States

Full record on ClinicalTrials.gov

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