Phase 2
Completed N=20
A Phase II Study to Evaluate Axumin PET/CT for Risk Stratification for Prostate Cancer
Source: ClinicalTrials.gov NCT03373006 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Detection of Metastases — 7; 8; 2; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Detection of Metastases |
7; 8; 2; 0; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03373006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.