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

• Status: Completed
• Trial end date: 2020-01-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Desert Medical Imaging

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.