Deferral of active treatment using focal irreversible electroporation for men with localised prostate cancer
- Conditions
- prostate cancerSurgery - Surgical techniquesCancer - Prostate
- Registration Number
- ACTRN12621001652864
- Lead Sponsor
- A/Prof Nathan Lawrentschuk
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 100
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
•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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method