RCT IRE Prostate

• Research type

  Research Study

• Full title

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

• IRAS ID

  179494

• Contact name

  Gordon Muir

• Contact email

  gordon.muir@nhs.net

• Sponsor organisation

  Clinical Research Office of the Endourological Society

• Clinicaltrials.gov Identifier

  NCT01835977

• Duration of Study in the UK

  3 years, 3 months, 1 days

• Research summary

  Ablation with Irreversible Electroporation (IRE) has shown to be effective and safe in destroying tumour cells and to have the potential advantage of sparing surrounding tissue and vital structures such as blood vessels and nerves.
  200 patients with confirmed unilateral (T1c-T2b) low risk (Gleason sum score 6) or intermediate risk prostate cancer (Gleason sum score 7) will be offered to have the IRE treatment. These patients will be randomized into one of the two arms of the study.

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

  Objectives of the study
  
  Primary:
  - To evaluate differences in side effect profile of patients treated with focal or extended ablation performed with image-guided IRE for the ablation of prostate carcinoma.
  - To evaluate differences in quality of life of patients treated with focal or extended ablation performed with image-guided IRE for the ablation of prostate carcinoma.
  Secondary:
  - To evaluate the oncological efficacy of image guided IRE for the focal and extended ablation of prostate carcinoma.
  - To evaluate the efficacy of MRI in the imaging of ablation success, extend of the ablation zone, 6 months and 1, 2, 3, 4 and 5 years post IRE ablation.

  Data will be collected and patients will be followed up at 1 day post-operatively, 2weeks, 1 month, 3 months, 6 months, 12 months and thereafter annually until 5 years post-IRE.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  16/LO/0035

• Date of REC Opinion

  29 Nov 2016

• REC opinion

  Further Information Favourable Opinion