MRI-guided focal laser ablation of prostate cancer: a prospective single-arm, single-center trial with 3 years of follow-up

Diagn Interv Radiol 2021;27(3):394-400

DOI: 10.5152/dir.2021.20095

1. Department of Urology and Pediatric Urology, University Medical Center, Mainz, Germany

2. Urologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA

3. Molecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA

4. Department of Urology, Michigan Medicine, University of Michigan, Ann Arbor, Michigan, USA

5. Houston Metro Urology, Houston, Texas, USA

6. Department of Urology and Radiology, University of Alabama, Birmingham, Alabama, USA

7. Mount Sinai Urology Associates, Mount Sinai Hospital, New York, USA

8. University of Maryland Medical Center, Baltimore, Marland

9. Laboratory of Pathology, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA

10. Division of Cancer Treatment and Diagnosis, Biometric Research Program, National Cancer Institute, National Institutes of Health, Rockville, Maryland, USA

11. Center for Interventional Oncology, National Cancer Institute and Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA

No information available.

No information available

Received Date: 29.02.2020

Accepted Date: 22.06.2020

PDF

Cite

Request

ABSTRACT

PURPOSE

We aimed to assess post-interventional and 36-month follow-up results of a single-center, single-arm, in-bore phase I trial of focal laser ablation (FLA) guided by multiparametric magnetic resonance imaging (mpMRI).

METHODS

FLA procedures were done in-bore MRI using a transperineal approach. Primary endpoints were feasibility and safety expressed as lack of grade 3 complications. Secondary endpoints were changes in international prostate symptom score (IPSS), sexual health inventory for men (SHIM), quality of life (QoL) scores, and serum prostate specific antigen (PSA) levels. Treatment outcomes were assessed by combined mpMRI-ultrasound fusion-guided and extended sextant systematic biopsy after 12, 24, and optionally after 36 months.

RESULTS

Fifteen participants were included. Seven patients (46.67%) had Gleason 3+3 and 8 patients (53.33%) had Gleason 3+4 cancer. All patients tolerated the procedure well, and no grade 3/4 complications occurred. All grade 1 and 2 complications were transient and resolved completely. There was no significant change in mean IPSS from baseline (-1, p = 0.460) and QoL (0, p = 0.441) scores following FLA but there was a significant drop in mean SHIM scores (-2, p = 0.010) compared to pretreatment baselines. Mean PSA significantly decreased after FLA (-2.5, p < 0.001). Seven out of 15 patients (46.67%) had residual cancer in, adjacent, or in close proximity to the treatment area (1 × 4+3=7, 1 × 3+4=7, and 5 × 3+3=6). Four out of 15 patients (26.67%) underwent salvage therapy (2 repeat FLA, 2 radical prostatectomy).

CONCLUSION

After 3 years of follow-up we conclude focal laser ablation is safe and feasible without significant complications.