International experts agree that most focal therapy techniques remain investigational and should be performed under an IRB-approved protocol and/or contribute to an IRB-approved registry – the HALO way. Below are the active and completed clinical trials, and the peer-reviewed publications, behind HALO’s laser focal therapy program for prostate cancer.
Active & Completed Trials
Phase II Laser Focal Therapy of Prostate Cancer — NCT02243033
Status: Active, not recruiting
A 20-year observational study evaluating outpatient MRI-guided laser focal therapy (using the Visualase® Thermal Therapy System) in men ages 45–90 with biopsy-confirmed, localized prostate cancer. Sponsored by HALO Diagnostics. Interim 13-year results, presented by Dr. John F. Feller at the American Urological Association Annual Meeting, showed a 100% prostate-cancer-specific survival rate with less than 1% risk of erectile dysfunction, incontinence, or infection.1
Location: Desert Medical Imaging, Indian Wells, CA. Principal Investigator: John F. Feller, MD. Study Director: Bernadette M. Greenwood, MSc.
View NCT02243033 on ClinicalTrials.gov
Axumin PET/CT for Risk Stratification — NCT03373006
Status: Completed
A Phase II study evaluating Axumin® (fluciclovine F 18) PET/CT to assess for metastatic disease in men undergoing laser focal therapy, helping determine which patients are appropriate candidates for a focal therapy cohort. Sponsored by HALO Diagnostics.
Location: Desert Medical Imaging, Indian Wells, CA. Enrollment: 20 participants. Principal Investigator: John F. Feller, MD. Study Director: Bernadette M. Greenwood, MSc.
View NCT03373006 on ClinicalTrials.gov
Selected Publications
van Luijtelaar A, Greenwood BM, Ahmed HU, et al. Focal laser ablation as clinical treatment of prostate cancer: report from a Delphi consensus project. World J Urol. 2019;37(10):2147–2153.2
Feller JF, Greenwood BM, Jones W, Gunberg S, Herz JJ, Toth RJ. MP25-04: 13-Year Interim Results for Transrectally Delivered, Outpatient MRI-Guided Laser Focal Therapy of Prostate Cancer in a Treatment Naive Cohort. J Urol. 2024;211(5S):e404. Presented at the American Urological Association Annual Meeting, May 4, 2024.3
Learn more about the procedure itself on our Laser Focal Therapy treatment page, or start an assessment to see if you may be a candidate.
References
1. https://clinicaltrials.gov/study/NCT02243033
2. https://doi.org/10.1007/s00345-019-02636-7
3. J Urol. 2024;211(5S):e404 – American Urological Association Annual Meeting, May 4, 2024.