MR-guided Focal Laser Ablation of the Prostate

Not Applicable

Completed

• Conditions: Prostate Cancer; MRI; Focal Laser Ablation
• Interventions: Device: MR-guided focal laser ablation

• Registration Number: NCT02200809
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-21
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-25
• Status Verified: 2018-04
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MR-guided focal laser ablation	MR-guided focal laser ablation	-

Primary Outcome Measures

Name	Time	Method
Disease free survival	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.

Trial Locations

Locations (3)

Radboud University Medical Center; 🇳🇱 Nijmegen, Gelderland, Netherlands

Ziekenhuisgroep Twente; 🇳🇱 Hengelo, Overijssel, Netherlands

Canisius Wilhelmina Hospital; 🇳🇱 Nijmegen, Gelderland, Netherlands