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Multi-Center Randomized Clinical Two Arm Intervention Study Evaluating Irreversible Electroporation for the Ablation of Localized Prostate Cancer


Phase 2
50 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Multi-Center Randomized Clinical Two Arm Intervention Study Evaluating Irreversible Electroporation for the Ablation of Localized Prostate Cancer


Inclusion Criteria:



1. ≥ 50 years

2. Histologically confirmed organ-confined unilateral prostate cancer (clinical stage
T1-T2)

3. High volume Gleason score 3 + 3 or Gleason score 3 + 4

4. PSA < 20 ng/ml

5. Able to visualize prostate gland adequately on transrectal US imaging during
enrolment evaluation

6. No prostate calcification greater than 5 mm

Exclusion Criteria:

1. Other Conditions/Status

- Bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds, partial
thromboplastin time (PTT) > 34 seconds, and Platelet Count < 140/µL

- Active urinary tract infection (UTI)

- History of bladder neck contracture

- Anaesthesia Surgical Assignment, category IV or greater

- History of inflammatory bowel disease

- Concurrent major debilitating illness

- Prior or concurrent malignancy

- Cardiac History

- ICD / Pacemaker

2. Prior or current therapies

- Biologic therapy for prostate cancer

- Chemotherapy for prostate cancer

- Hormonal therapy for prostate cancer within 3 months of procedure

- Radiotherapy for prostate cancer

- Transurethral prostatectomy (TURP), urethral stent

- Prior major rectal surgery (except haemorrhoids)

- Inability or unwillingness to tolerate temporary cessation of concurrent
anticoagulation therapy or anti-platelet drugs for a period of 7 days prior to
procedure and up to 7 days after procedure

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Patient experience (side-effects and quality of life) after IRE ablation of prostate cancer

Outcome Description:

To determine post procedural side-effects and Quality of life measured by International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF) and Functional Assessment of Cancer Therapy-Prostate (FACT-P).

Outcome Time Frame:

5 years

Safety Issue:

No

Authority:

Netherlands: Medical Ethics Review Committee (METC)

Study ID:

2013249

NCT ID:

NCT01835977

Start Date:

January 2014

Completion Date:

January 2019

Related Keywords:

  • Prostate Cancer
  • Focal therapy
  • Irreversible electroporation
  • Unilateral prostate cancer
  • Prostatic Neoplasms

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