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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47783

Enrollment

Registered

2015-02-03

Start date

2015-06-16

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostaat Carcinoma Prostate Cancer

Interventions

Arm 1: Focal IRE ablation of the prostate at the location of positive biopsies. Arm 2: Extended IRE ablation of the prostate at the side of the positive biopsies.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 counseled with caution 4. Life expectancy of > 10 years

Exclusion criteria

Exclusion criteria: 1. Bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds, partial thromboplastin time (PTT) > 34 seconds, and Platelet Count

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)