MRI-guided Focal Laser Ablation

Phase 2

• Conditions: Prostate Cancer

• Registration Number: NCT04379362
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Magnetic resonance imaging-guided focal laser ablation of prostate cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-14
• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-07
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-22
• Primary Completion: 2022-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Urine incontinence incontinence	At inclusion, 3 months, 6 months, 12 months and 24 months follow up.	To evaluate a change in the functional outcome urine incontinence before and after FLA in patients with localized low to intermediate risk prostate cancer (Gleason 3+3, 3+4 or Gleason 4+3).

Secondary Outcome Measures

Name	Time	Method
Sexual Health Inventory for Men- International Index of Erectile Function (SHIM-IIEF)	At inclusion, 3 months, 6 months, 12 months and 24 months follow up.	To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. Sexual Health Inventory for Men- International Index of Erectile Function (SHIM-IIEF)
Complication rate	At inclusion , 3 months, 6 months, 12 months and 24 months follow up.	To evaluate the complication rate related to the technique
International Consultation on Incontinence Questionnaire (ICIQ)	At inclusion, 3 months, 6 months, 12 months and 24 months follow up.	To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. the International Consultation on Incontinence Questionnaire (ICIQ).
Quality of life using a validated quality of life questionnaire (EORTC QLQ PR25	At inclusion , 3 months, 6 months, 12 months and 24 months follow up.	To evaluate quality of life before and after FLA in men with prostate cancer by using a validated quality of life questionnaire (EORTC QLQ PR25).
Local cancer control	At inclusion , 3 months, 6 months, 12 months and 24 months follow up.	To assess the safety outcome local cancer control achieved at the ablation site after FLA by multiparametric MR imaging and targeted prostate biopsies.
International Prostate Symptom Score (IPSS)	At inclusion, 3 months, 6 months, 12 months and 24 months follow up.	To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. International Prostate Symptom Score (IPSS)

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Netherlands