RecruitingACTRN12617000806369

A pilot study evaluating focal irreversible electroporation as treatment for participants with recurrent prostate cancer after radiotherapy.

Focal irreversible electroporation as salvage treatment in radio-recurrent prostate cancer: a prospective multi-centre pilot study

Sponsor

St. Vincent’s Private Hospital

Enrollment

10 participants

Start Date

Aug 3, 2017

Study Type

Interventional

Conditions

Recurrent Prostate Cancer

Summary

This study aims to assess the safety profile and functional outcomes of salvage focal irreversible electroporation (IRE) in patients with prostate cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with local recurrent prostate cancer after radiotherapy (radio-recurrent prostate cancer) without metastatic disease. Study details All participants in this study will undergo a procedure known as salvage focal irreversible electroporation (IRE) as day surgery at St Vincent’s Private Hospital. The procedure is conducted under general anaesthesia and involves insertion of up to 6 needle-like electrode probes around the tumour. Microsecond electrical probes are then delivered to the tumour area to cause cell death and destroy the tumour. The procedure is conducted by a urologist and takes approximately 60 minutes. Participants will be monitored for safety throughout the procedure, and at 3, 6 and 12 months after the procedure. They will also be asked to complete questionnaires at these time points to assess quality of life and urinary and sexual functional outcomes. Cancer recurrence will also be assessed at 6 month and at one year post treatment. The results of this trial will build on a currently developing evidence base in order to guide the judicious use of IRE in patients with localised, radio-recurrent prostate cancer.

Eligibility

Sex: MalesMin Age: 18 Yearss

Inclusion Criteria10

Patients with radio-recurrent PCa greater or equal than 2 years post LDR or PDR or HDR brachytherapy or external beam radiation therapy
Imaging negative for metastatic disease
Radiological stage T1 to T3aN0M0 disease
Lesion visible on mpMRI with good biopsy co-registration
Histologically proven Gleason 7 to 10 PCa
PCa recurrence limited to a single lesion in the prostate as indicated by pre-operative mpMRI and biopsy
PSA smaller than 10 ng per mL
Fulfil Phoenix criteria (Nadir plus 2)
Life expectancy: 10 years or more
Able to provide written consent

Exclusion Criteria14

Biopsy proven lymph node involvement
Metastatic disease
Bowel disease (e.g. IBD)
Previous transurethral resection of the prostate (TURP)
Major medical or psychiatric illness, which in the investigator’s opinion, would prevent completion of treatment and/or follow-up
Inability to undergo mpMRI
a. Incompatible metallic implants
b. Claustrophobia
Men unable to tolerate transrectal ultrasound
Men who have undergone previous focal therapy to the prostate (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)

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Interventions

The NanoKnife (Registered Trademark) System with six outputs is indicated for the surgical ablation of soft tissue. It has FDA approval [510(k) Number: K080376]. Intended use in this study is to treat radio-recurrent prostate cancer. Patients will receive general anaesthesia, followed by intravenous muscle paralysis, a single-shot antibiotic prophylaxis and the insertion of an indwelling urethral catheter. Up to 6 Needle-like electrode probes are then placed around the tumour using transrectal ultrasound for guidance during the insertion through the perineum with a 5x5 mm brachytherapy template grid.. The placement of the electrodes aims for focal ablation of the tumour. This will include a circumferential safety margin of at least 5mm whilst still being mindful of nearby vital structures. Technical considerations include spacing of the electrodes (required to be 10mm to 20mm apart), and an average electrode exposure length per needle of 15mm. The number of electrodes required for each patient is dependent on the volume of tissue to be ablated and will be determined by the treating clinician before the procedure. The Nanoknife system is then programmed to start with 10 pulses per electrode-pair with pulse length set to 90 microseconds and intensity of 1500 V per cm. Treatment delivery is then automatically calculated by the system on the basis of the number of electrodes inserted, the respective distances between each electrode and the active electrode length to obtain an optimal electrical field of between 20A and 40A. If the current does not reach the minimum of 20 amps between one or more electrode-pairs, the voltage will have to be increased with 10 percent for that particular electrode-pair. Following the initial 10 pulses, the subsequent 80 pulses will be delivered to achieve a total of 90 pulses. The total procedure time is estimated to be 1 hour, starting with the administration of general anaesthesia. The actual Nanoknife procedure will take around 30min. A Urologist, the coordinating investigator (CI), will perform the procedure once as day surgery at St Vincent’s Private Hospital. The CI has a great expertise in the treatment of prostate cancer in Australia and has 4 years experience conducting the procedure, primarily in the setting of primary prostate cancer. Adherence of the intervention is assessed by the treating Urologist. In addition a second medical doctor or nurse is present during the procedure to ensure settings and adjustments are correctly entered in the Nanoknife system. A procedural template will be filled out during the procedure to help with accurate recording of all settings and adjustments made during procedure.