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
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