Clinical trial · Interventional
Targeted Fusion Biopsy of the Prostate
NCT02744534CI-TRIAL-00038525completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FACBC PET-CT Scan | Drug | — | UNRESOLVED |
| Standard transrectal ultrasound (TRUS) guided biopsy | Procedure | — | UNRESOLVED |
| Three-dimensional ultrasound-guided biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Abnormalities found with FACBC PET-CT
- description
- All participants with suspected recurrence of prostate cancer will have the FACBC PET-CT scan performed. Participants with abnormal FACBC PET-CT scan results will have a PET/ultrasound fusion targeted prostate biopsy followed a standard of care prostate biopsy.
- interventionNames
- Drug: FACBC PET-CT Scan
- Procedure: Three-dimensional ultrasound-guided biopsy
- Procedure: Standard transrectal ultrasound (TRUS) guided biopsy
- type
- ACTIVE_COMPARATOR
- label
- No abnormalities found with FACBC PET-CT
- description
- All participants with suspected recurrence of prostate cancer will have the FACBC PET-CT scan performed. Participants without abnormal FACBC PET-CT scan results will have a standard of care prostate biopsy.
- interventionNames
- Drug: FACBC PET-CT Scan
- Procedure: Standard transrectal ultrasound (TRUS) guided biopsy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.