Prostate cancer Prostate carcinoma
Conditions
Interventions
Patient group A will undergo additional MR-guided focal cryosurgery before they
undergo radical prostatectomy and patient group B will receive MR-guided
cryosurgery instead of US-guided cryosurgery.
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and feasibility of MR-guided focal cryosurgery in vivo in newly diagnosed prostate cancer patients and in patients with recurrent prostate cancer after radiotherapy is described by potential complications and ASTRO-criteria for disease-free survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| The accuracy of cryoneedle placement under MR guidance is given by measuring the in plane error at the MR images retrospectively. The accuracy of MR temperature mapping by measuring the temperature with MR compatible temperature sensors. The correlation between the MR results from multimodality MR and temperature mapping with the pathological results. | — |
Countries
Netherlands
Outcome results
None listed