A Multi-Center Randomized Single-Blind Two Arm Intervention Study Evaluating Irreversible Electroporation for the Ablation of Prostate Cancer

Phase 3

Completed

Conditions: Prostaat Carcinoma
10038597
Prostate Cancer
10025506

Registration Number: NL-OMON47783

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

1. Histologically confirmed organ-confined unilateral prostate cancer on
transperineal template prostate biopsies or MRI targeted biopsies in
combination with systematic biopsies (clinical stage T1c-T2a)
2. Gleason score 6 or Gleason score 7
3. PSA <15 ng/ml or PSA > 15 ng/mL counseled with caution
4. Life expectancy of > 10 years

Exclusion Criteria

1. Bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds,
partial thromboplastin time (PTT) > 34 seconds, and Platelet Count < 140/uL
2. No ability of subject to stop anticoagulant and anti-platelet therapy for
7 days prior the procedure.
3. Active urinary tract infection (UTI)
4. History of bladder neck contracture
5. Anaesthesia Surgical Assignment category III or greater
6. History of inflammatory bowel disease
7. Concurrent major debilitating illness
8. Prior or concurrent malignancy except for basal cell carcinoma of the skin
9. Cardiac History including arrhythmias, ICD or pacemaker
10. Prostate calcifications greater than 5 mm
11. Biologic or chemotherapy for prostate cancer
12. Hormonal therapy for prostate cancer within 6 months prior to procedure
13. Previous radiation to pelvis
14. Transurethral resection of the prostate / Urethral stent
15. Prior major rectal surgery (except haemorrhoids)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate differences in side effect profile of patients who have been<br /><br>treated with focal or extended ablation performed with image-guided IRE for<br /><br>prostate carcinoma:<br /><br><br /><br>- To determine post procedural erectile dysfunction measured by the<br /><br>International Index of Erectile Function-5 (IIEF-5).<br /><br><br /><br>- To determine the treatment related adverse events measured by CTCAE Version<br /><br>4.0<br /><br><br /><br>- To determine the urinary side effects by the International Prostate Symptom<br /><br>Score (IPSS), IPSS quality of life and use of pads.<br /><br><br /><br>- To evaluate differences in quality of life of patients measured by the<br /><br>Expanded Prostate Index Composite (EPIC) and Visual Analogue Scale (VAS) pain<br /><br>score.<br /><br><br /><br>The patient groups randomized in focal ablation and extended ablation will be<br /><br>compared.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To determine the oncological efficacy as measured by the proportion of men<br /><br>who are free of any prostate cancer in the two different groups. This will be<br /><br>examined by standardized prostate biopsies and targeted biopsies after<br /><br>multiparametric-MRI at 1 year post-IRE.<br /><br><br /><br>- To evaluate the efficacy of MRI in the imaging of ablation success, extend of<br /><br>the ablation zone, 3 months and 6 months, 1,2,3,4 and 5 years post IRE<br /><br>ablation.</p><br>