MR-guided focal laser ablation of the prostate: a pilot study

Phase 2

Recruiting

Conditions: prostate cancer
prostate carcinoma
10027656
10036958

Registration Number: NL-OMON36226

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Inclusion criteria counting for both groups:
• Newly diagnosed and biopsy proven prostate cancer
• Low risk patients (PSA <= 10 ng/mL, Gleason 3+3, cT1c - T2a)
• No previous treatment for prostate cancer
• Cancer lesion located at least 2 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);Additional inclusion criterion for patients in group A:
• Patients must be scheduled for a radical prostatectomy with a lesion of max 4 cm

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The feasibility of MR-guided focal laser ablation in vivo in newly diagnosed<br /><br>PCa patients. Potential complications are recorded, and the success rate will<br /><br>be determined by MR-imaging after 1 - 3 weeks and a combination of MR imaging<br /><br>and MR-guided biopsy after 6, 12, 18, 24 and 36 months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• To determine the accuracy of laser fibre placement under MR guidance by<br /><br>measuring the 3D error at the MR images retrospectively.<br /><br>• To correlate the MR results from multimodality MR and temperature mapping<br /><br>with the pathological results.<br /><br>• To determine the role of imaging in predicting histological outcomes of<br /><br>transrectal focal laser ablation therapy in the treatment of localised prostate<br /><br>cancer. </p><br>