None listed
Conditions
Brief summary
Prostate cancer continues to be one of the most commonly diagnosed cancer in men and a leading cause of cancer related death worldwide. When prostate cancer is in its early stages, meaning that it has not spread outside the prostate gland, surgical excision of the prostate and radiation to the pelvis have been shown to be effective treatments. However, these treatments frequently leave men with side effects. The main two being erectile dysfunction and urinary incontinence. Over the last decade, new treatment strategies have been aimed at delaying or mitigating the need for prostate excision or radiation therapy to save men from these side effects. Irreversible electroporation (IRE) is a new form of technology which uses electrical pulses to kill cancer cells within the prostate. These electrical pulses are applied through metal probes placed strategically around the cancer in the prostate. The heat generated is kept below “thermal” levels to ensure important structures that surround the prostate (nerves and blood vessels) are not damaged by the treatment. For the moment, studies on IRE have been limited by numbers and short term follow up data. This study will follow and analyse men undergoing IRE. It will include men who have newly diagnosed localised prostate cancer and also men who have localised recurrent prostate cancer after radiotherapy. We aim to assess cancer outcomes through a series of imaging (MRI and PSMA PET/CT), blood tests and biopsies (TP biopsy). Additionally, we aim to analyse functional outcomes through questionnaires. Our study will add the growing evidence of men undergoing IRE around the world. Who is it for? You may be eligible to participate if you are aged 18 years or older, and have been diagnosed with prostate cancer - either newly diagnosed localised prostate cancer, or localised recurrent prostate cancer after radiotherapy. Study details: All participants will undergo IRE surgery, conducted under general anaesthesia. The surgery will take around 30-60mins. Follow up will consist of a 3, 6 and 12 months review. This will be done in clinic with the treating Urologist. At 3 months, participants will be assessed with a serum PSA, and completed EPIC-26 Quality of Life questionnaire. At 6 months, participants will be assessed with a PSA, EPIC-26 Quality of Life questionnaire and prostate MRI. At 12 months, participants will be assessed with a PSA, EPIC-26 Quality of Life questionnaire, PSMA PET and prostate biopsy. It is hoped that this research will improve understanding of IRE treatment, and lead to better treatment for men with prostate cancer.
Interventions
Qualified Urologists will perform focal irreversible electroporation (IRE) for men with localised prostate cancer. This will be done in a surgical theatre with the patient under general anaesthesia. This procedure usually take around 30-60mins.
IRE will be performed at an Epworth HealthCare affiliated hospital. This will be a day procedure. Participants will be discharged with Panadol and voltaren for pain and flomaxtra for any urinary issues. They will also had a urinary catheter on discharge.
Qualified Urologists will perform focal irreversible electroporation (IRE) for men with localised prostate cancer. This will be done in a surgical theatre with the patient under general anaesthesia. This procedure usually take around 30-60mins. IRE will be performed at an Epworth HealthCare affiliated hospital. This will be a day procedure. Participants will be discharged with Panadol and voltaren for pain and flomaxtra for any urinary issues. They will also had a urinary catheter on discharge. This will be removed via trial of void by a urology nurse 2-5 days post operatively. Follow up will consist of a 3, 6 and 12 months review. This will be done in clinic with the treating Urologist. At 3 months, participants will be assessed with a serum PSA, and completed EPIC-26 Quality of Life questionnaire. At 6 months, participants will be assessed with a PSA, EPIC-26 Quality of Life questionnaire and prostate MRI. At 12 months, participants will be assessed with a PSA, EPIC-26 Quality of Life questionnaire, PSMA PET and prostate biopsy. These follow up protocols coincide with the published Delphi consensus for focal therapy.
Sponsors
A/Prof Nathan Lawrentschuk
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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 o HIFU, 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)
Outcome results
None listed