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Updated: May 7, 2025
Focal Laser Ablation of Prostate Cancer: An Office Procedure
Published on: March 30, 2021
Targeted microwave ablation of localised prostate cancer: Initial results of VIOLETTE trial
Nicolas Barry Delongchamps1, Alexandre Peltier2, Eric Potiron3
1Department of Urology, Cochin Hospital, Assistance Publique - Hôpitaux de Paris Université Paris Cité Paris France.
Objective:
The aim of this study was to assess the precision and safety of targeted microwave ablation (TMA) using organ-based tracking (OBT) fusion, in patients with intermediate risk prostate cancer.
Patients And Method:
We conducted a prospective, multicentric trial. Eligible patients had a prostate-specific antigen (PSA) < 20 ng/mL, a magnetic resonance imaging (MRI)-visible index tumour of Gleason score 3 + 4, with largest axis ≤15 mm and distant of at least 5 mm from the rectum and apex. TMA was performed with microwave needle applicator using OBT fusion, with a transperineal or a transrectal approach. In this interim analysis, we evaluated precision, safety, urinary and sexual outcomes, and PSA density kinetics.
Results:
At this point, 37 patients were treated in five centres. Median (interquartile range) age is 68 (63-72) years. Baseline median prostate volume and PSA are of 45 (34-57) mL and 8 (6.2-10.8) ng/mL, respectively. Median largest tumour axis on T2W MRI is of 11 mm (10-13). Patients were treated under general anaesthesia or conscious IV sedation in an outpatient setting. Anaesthesia had a median duration of 78 (66-90) min. A median number of 3 (2-4) 12-W ablations of 2 to 5 min were performed per patient. After a median follow-up of 6 (2.4-10) months, we observed 58 adverse events (AE) in 22 patients. These were of Common Terminology Criteria for Adverse Events (CTCAE) grade 1, 2 and 3 in 43 (74%), 13 (22%) and 2 (4%) cases. Six (15%) patients had an acute urinary retention, five of which considered as severe AE because of rehospitalisation. We did not observe any significant difference in International Prostate Symptom Score (IPSS), Male Sexual Health Questionnaire-ejaculatory dysfunction (MSHQ-EjD) and International Index of Erectile Function (IIEF5) from baseline to last follow-up. Median PSA density evolved from 0.2 (0.1-0.3) at baseline to 0.1 (0.07-0.16) at 12 months.
Conclusions:
These preliminary results suggest that TMA using OBT fusion is precise and safe in patients with intermediate risk localised prostate cancer. Further inclusions and follow-up are needed to assess oncological outcome.
Insights
Targeted microwave ablation (TMA) with organ-based tracking (OBT) fusion shows precision and safety for intermediate-risk prostate cancer. This minimally invasive approach preserves urinary and sexual function, with reduced PSA density post-treatment.
Area of Science:
- Urology
- Oncology
- Minimally Invasive Surgery
Background:
- Prostate cancer management requires precise and safe treatment options.
- Intermediate-risk prostate cancer presents a challenge for localized treatment.
- Minimally invasive techniques are gaining traction for improved patient outcomes.
Purpose of the Study:
- To evaluate the precision and safety of targeted microwave ablation (TMA) using organ-based tracking (OBT) fusion.
- To assess urinary and sexual function outcomes after TMA.
- To analyze prostate-specific antigen (PSA) density kinetics following the procedure.
Main Methods:
- Prospective, multicentric trial involving patients with intermediate-risk prostate cancer.
- TMA performed using microwave needle applicators with OBT fusion (transperineal or transrectal approach).
- Interim analysis included evaluation of precision, safety, urinary/sexual outcomes, and PSA density.
Main Results:
- 58 adverse events (AE) in 22 patients, mostly low-grade (CTCAE grade 1 or 2).
- No significant difference in International Prostate Symptom Score (IPSS) or sexual function scores (MSHQ-EjD, IIEF5) from baseline.
- Median PSA density decreased from 0.2 to 0.1 at 12 months.
Conclusions:
- TMA with OBT fusion appears precise and safe for intermediate-risk localized prostate cancer.
- The procedure demonstrated favorable urinary and sexual function preservation.
- Further patient enrollment and follow-up are necessary to confirm oncological efficacy.
