Skip to main content
Clinical Trials/ACTRN12621001652864
ACTRN12621001652864Recruiting未知

The efficacy of treatment with focal irreversible electroporation for men with localised prostate cancer

A/Prof Nathan Lawrentschuk0 sites100 target enrollmentStarted: December 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
未知
Status
Recruiting
Sponsor
Enrollment
100

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Non-randomised trial
Primary Purpose
Treatment
Masking
Open (masking not used)

Eligibility Criteria

Ages
18 Years to o limit (—)
Sex
Male

Inclusion Criteria

  • 1)Primary prostate cancer (PCa) diagnosis
  • a.Gleason score less than or equal to 7 (grade group 3 or less)
  • b.Radiological stage T1-T3
  • c.No previous treatment for PCa
  • 2)Radio-recurrent prostate cancer
  • a.Radio-recurrent prostate cancer greater or equal to 2 years post LDR/PDR/HDR brachytherapy or EBRT
  • 3)Both groups
  • a.Imaging negative for metastatic disease
  • b.Radiological stage T1-T3
  • c.Lesion visible on prostate MRI
  • d.Unilateral or single midline anterior/posterior index tumour, allowing single targeted ablative therapy
  • e.Lesion confirmed with targeted prostate biopsy
  • f.Life expectancy over 10 years
  • g.No previous androgen suppression/hormone treatment for PCa
  • h.Can give written consent in English

Exclusion Criteria

  • Biopsy proven lymph node involvement
  • Metastatic disease
  • Bowel disease (e.g. IBD)
  • Previous transurethral resection of the prostate (TURP)
  • Inability to undergo mpMRI
  • Incompatible metallic implants
  • Claustrophobia
  • Men unable to tolerate transrectal ultrasound
  • Men who have undergone previous focal therapy to the prostate
  • oHIFU, IRE, cryosurgery, thermal, microwave, laser therapy
  • Men who have received androgen suppression/hormone treatment within the last 6 months
  • Metallic implants or stents in urethra
  • Histological evidence of any cancer in more than one area of the prostate
  • Requires simultaneous urological procedure at time of salvage IRE (e.g. mini-TUR)

Investigators

Sponsor
A/Prof Nathan Lawrentschuk

Similar Trials