MR-guided Focal Laser Ablation of the Prostate

Radboud University Medical Center3 sites in 1 country20 target enrollmentJuly 2014

ConditionsProstate Cancer MRI Focal Laser Ablation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Radboud University Medical Center
Enrollment: 20
Locations: 3
Primary Endpoint: Disease free survival
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Purpose of the investigators study is to determine the short and medium term histological cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment of localised prostate cancer.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

December 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Radboud University Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Newly diagnosed and biopsy proven prostate cancer
•Intermediate risk patients (PSA \<= 20 ng/mL, Gleason ≤ 7, T2b)
•No previous treatment for prostate cancer
•Cancer lesion located at least 1 cm away from the neurovascular bundle according to Multimodality MR images
•Signed informed consent by patient
•Age 18 years or older
•Signed screening form (to determine exclusion for metal device/foreign bodies/claustrophobia)

Exclusion Criteria

•Impossibility to obtain a valid informed consent
•Patients unable to undergo MR imaging, including those with contra-indications
•Contra-indications to MR guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection)
•Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging
•Patients with evidence for nodal or metastatic disease
•Patients with an estimated Glomerular Filtration Ratio (eGFR) \< 40 mL/min/1.73 m2

Outcomes

Primary Outcomes

Disease free survival

Time Frame: 36 months.

The short and medium term histological cancer control defined as the percentage of patients with disease free survival according to the pathological MR-guided biopsy results after 36 months.