Magnetic Resonance Imaging-guided Focal Laser Ablation of Prostate Cancer

Radboud University Medical Center1 site in 1 country53 target enrollmentDecember 14, 2018

ConditionsProstate Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Radboud University Medical Center
Enrollment: 53
Locations: 1
Primary Endpoint: Urine incontinence incontinence
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

December 14, 2018

End Date

July 1, 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Radboud University Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Urine incontinence incontinence

Time Frame: 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 Outcomes

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.)
Complication rate(At inclusion , 3 months, 6 months, 12 months and 24 months follow up.)
International Consultation on Incontinence Questionnaire (ICIQ)(At inclusion, 3 months, 6 months, 12 months and 24 months follow up.)
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.)
Local cancer control(At inclusion , 3 months, 6 months, 12 months and 24 months follow up.)
International Prostate Symptom Score (IPSS)(At inclusion, 3 months, 6 months, 12 months and 24 months follow up.)