Phase 2 N=21 Diagnostic

Targeted Fusion Biopsy of the Prostate

Prostatic Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT02744534 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Percentage of Cores Positive for Cancer — 32.0; 4.5 percentage of positive core samples

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: FACBC PET-CT Scan (Drug); Three-dimensional ultrasound-guided biopsy (Procedure); Standard transrectal ultrasound (TRUS) guided biopsy (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Emory University
Primary completion: Mar 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Cores Positive for Cancer	32.0; 4.5	—

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.

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

View full record on ClinicalTrials.gov →

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.