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Clinical Trials/NL-OMON34160
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Withdrawn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Withdrawn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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
niversitair Medisch Centrum Sint Radboud

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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