MR-guided focal cryosurgery of the prostate: a pilot study*

Withdrawn

Conditions: Prostate carcinoma
10038597
10036958
Prostate cancer
10025506

Registration Number: NL-OMON34160

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

We plan to enroll thirty patients in total, divided over two groups; A and B. Ten patients with newly diagnosed and pathological proven PCa, which have a tumor confined to one prostate lobe and which is not located near the neurovascular bundle and no prior hormonal or radiation treatment will be included in group A. In group B twenty patients with biopsy-proven local recurrence of the prostate without distant metastases after radiotherapy will be included.;Additional inclusion criteria counting for both groups:
• 18 years of age or more
• Pathologically proven PCa
• Signed screening form (to search for metal device/foreign bodies/claustrophobia)
• Signed IRB-approved informed consent form

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 cryosurgery (colitis ulcerosa, rectal pathology or dominoperineal resection)
• Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging
• A prostate volume > 50 mL
• No data available from whole-mount step-section pathologic analysis to use as reference standard (group A)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The safety and feasibility of MR-guided focal cryosurgery in vivo in newly<br /><br>diagnosed prostate cancer patients and in patients with recurrent prostate<br /><br>cancer after radiotherapy is described by potential complications and<br /><br>ASTRO-criteria for disease-free survival. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The accuracy of cryoneedle placement under MR guidance is given by measuring<br /><br>the in plane error at the MR images retrospectively. The accuracy of MR<br /><br>temperature mapping by measuring the temperature with MR compatible temperature<br /><br>sensors. The correlation between the MR results from multimodality MR and<br /><br>temperature mapping with the pathological results.</p><br>