NL-OMON34160
Withdrawn
Not Applicable
MR-guided focal cryosurgery of the prostate: a pilot study* - MR-guided focal cryosurgery
niversitair Medisch Centrum Sint Radboud0 sites30 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate cancer
- Sponsor
- niversitair Medisch Centrum Sint Radboud
- Enrollment
- 30
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
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