Phase 2
Completed N=21
Targeted Fusion Biopsy of the Prostate
Source: ClinicalTrials.gov NCT02744534 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Percentage of Cores Positive for Cancer — 32.0; 4.5 percentage of positive core samples
Summary
The purpose of this study is to see if using Positron Emission Tomography (PET) scan and transrectal ultrasound (TRUS) guided biopsy together (creating a 3-dimensional ultrasound) will detect prostate cancer more accurately than the standard 2-dimensional approach which uses only the TRUS to guide the biopsy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Cores Positive for Cancer |
32.0; 4.5 | — |
Eligibility Criteria
Inclusion Criteria
- Have been originally diagnosed with prostate carcinoma and have undergone definitive non-prostatectomy therapy for localized disease
- There is suspicion of recurrent prostate carcinoma as defined by: Older American Society for Radiation Oncology (ASTRO) criteria of three consecutive rises of prostate-specific antigen (PSA) or earlier if clinically appropriate, and/or nadir + 2.0 ng/ml (Radiation Therapy Oncology Group (RTOG)-ASTRO Phoenix criteria)
- Able to provide written informed consent
Exclusion Criteria
- Cryotherapy, external beam radiation, or high intensity focused ultrasound (HIFU) within the past year
- Brachytherapy within the past two years (to rule out a transient rise in PSA)
- Prostate biopsy within the past month (to decrease a false positive result due to inflammation)
- Not otherwise eligible for prostate biopsy
Data sourced from ClinicalTrials.gov (NCT02744534). 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.