Prostate Cancer Prostate Malignancy
Conditions
Interventions
Patients will undergo IRE as focal treatment for PCa.
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Signed written informed consent - Age >40 years, and life expectancy of *10 years. - Serum PSA
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Patients who are unwilling to sign written informed consent - Patients with ASA *4 - Patients with evidence of lesions in contact with the prostatic capsule on mpMRI. - Patients with evidence of metastatic or nodal disease outside the prostate on mpMRI. - Patients with GS >7. - Patient with capsular contact of tumour *6mm in the prostate. - Patients with previous treatment for PCa. - Patients with a history of radiotherapy to the pelvis. - Patients with a history of androgen suppression/hormonal therapy. - Patients unable to undergo a TRUS. - Patients who meet exclusion criteria for MRI following the protocol of the radiology department of the St. Antonius Hospital. - Patients fulfilling the exclusion criteria for the Gadovist gadolinium (Glomerular Filtration Rate (GFR) of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Assessment of urinary incontinence in patients with localized PCa, 24 months after focal IRE therapy, measured by EPIC-26 questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Assessment of genito-urinary and rectal side effects in patients with localized PCa after focal IRE therapy, measured by IPSS-QoL, EPIC-26, IIEF-15, EQ-5D, EORTC-QLQ-C30&PR25, SHIM, HADS, ICIQ and WAI. - Assessment of disease control in patients with localized PCa after focal IRE therapy, measured by mp-MRI 12 months after IRE therapy, by re-biopsy after 12 months, and by periodic PSA testing. - Assessment of the utilization of mp-MRI in patients with localized PCa after focal IRE therapy, to evaluate ablation zone periodically, by mpMRI after 12 months. - Assessment of complications in patients with localized PCa after focal IRE therapy, measured by the Clavien-Dindo classification of surgical complications. | — |
Countries
Netherlands
Outcome results
None listed