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Trial registered on ANZCTR

Registration number

ACTRN12612000523808

Ethics application status

Approved

Date submitted

21/03/2012

Date registered

16/05/2012

Date last updated

24/09/2014

Type of registration

Retrospectively registered

Titles & IDs

Public title

The safety and efficacy of Irreversible Electroporation for the ablation of prostate cancer assessed by procedural related side effects and post prostatectomy histology: A pilot study

Scientific title

Patients with prostate cancer scheduled for a prostatectomy to have an Irreversible Electroporation procedure two to four weeks prior to the prostatectomy for the researchers to determine the effectiveness of irreversible electroporation on a small region in the prostate.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Prostate cancer

Condition category

Condition code

Cancer

Prostate

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Irreversible Electroporation for the ablation of the prostate. Irreversible electroporation is done under general anaesthetic. Two fine needle electrodes are placed percutaneously into the prostate. An electric current is passed between the needle electrodes. This causes the pores of the cell membranes to open killing the cells. the procedure will take about and hour and a half. This is a preliminary study for the researchers to assess the safety of the procedure and to determine the accuracy of the planned ablation. In this study the IRE procedure is not being done to treat the prostate cancer, it is being done to assess the procedure. A standard radical prostatectomy will be performed 14 to 30 days post-IRE. Post prostatectomy, efficacy of the IRE ablation will be determined by histological examination of the prostate by The Alfred Anatomical Pathology Department and measured as complete or incomplete ablation.

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

The results of this study and its discovered side effects will be used as a means of comparison of the safety of IRE ablation against the side effects associated with current standard treatments for prostate cancer. Comparators are the side affects associated with radical prostatectomy, radiotherapy (External Beam Radiotherapy and brachytherapy), Hormone (androgen) Deprivation Therapy, cryoablation, high-intensity focused US, RadioFrequency Ablation, microwave coagulation, Vascular Targeted Photodynamic Therapy and Interstitial Laser Thermotherapy.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To determine if the Irreversible Electroporation (IRE) ablation procedure is safe as measured by the composite number of procedural, device and post procedural adverse events measured with the Common Terminology Criteria for Adverse Events (CTCAE) proforma.

It is unknown what the potential adverse events may be for IRE ablation in the prostate. Major procedural complications documented from the literature on prostate cancer treatments and device related adverse events include:
- Major infection, noted as a result of patient symptoms.
- Incontinence ( > 14 days postoperatively) Injury to the external sphincter resulting in incontinence and injury to the prostatic urethra resulting in obstruction that does or has the potential to result in needing a transurethral resection of the prostate or prolonged urinary drainage and a suprapubic catheter
- Urinary retention requiring suprapubic catheter (> 14 days postoperatively)
- Postoperative haemorrhage requiring transfusion Clinically significant bleeding requiring transfusion
- Fistula formation Local complications to surrounding the prostate might include injury to the rectum resulting in urethro-rectal fistula. Both symptomatic and asymptomatic fistula formation will be evaluated and recorded.
- Bladder neck contracture
- Urethral stricture
- Change in potency
- Haemorrhage requiring transfusion
- Coagualopathy
- Renal dysfunction
- Liver dysfunction
- Urethral sloughing
- Enlarged breasts
- Death related to, or possibly related to, the procedure. (No prostate ablation related deaths have been reported in the literature)

Minor procedural complications
- Probe site pain
- Scrotal swelling
- Haematuria
- Bleeding not requiring transfusion
- Minor infection
- Transient incontinence

Timepoint [1]

At IRE procedure, post-IRE procedure, 1 week post-IRE procedure, 2 weeks post-IRE procedure, pre-prostatectomy, at prostatectomy procedure, post-prostatectomy procedure, 1 week post-prostatectomy procedure

Primary outcome [2]

To determine if procedural side effects associated with current treatments for prostate cancer, mainly incontinence, erectile dysfunction and bowel damage are avoided as measured by the validated prostate cancer scores - Expanded Prostate Cancer Index Composite (EPIC), International Index for Erectile Function (IIEF-5) and International Prostate Symptom Score (IPSS)

Timepoint [2]

At baseline and at 2 weeks post-IRE procedure

Primary outcome [3]

To determine if complete ablation of the specified targeted ablation zone is achieved as measured by histopathology assessment.

Timepoint [3]

Post-prostatectomy

Secondary outcome [1]

To determine patient satisfaction and comfort measured by Patient Satisfaction Questionnaire.

Timepoint [1]

At post-IRE procedure and post-prostatectomy procedure

Secondary outcome [2]

To determine post procedural pain management and pain scores (using medical records for pain management treatments used and the 'Pain Score Data Sheet' which is a 10 cm line for analogue indication by patient of pain being felt)

Timepoint [2]

Both IRE and prostatectomy: post procedure, 2 hours, 4 hours, 24 hours, 1 week.

Secondary outcome [3]

To determine time to ambulation after IRE and prostatectomy (using medical records and clinical assessment)

Timepoint [3]

Post IRE procedure, post prostatectomy procedure

Secondary outcome [4]

To determine length of hospital stay after IRE and prostatectomy (using medical records).

Timepoint [4]

Post IRE procedure, post prostatectomy procedure

Secondary outcome [5]

To determine cost effectiveness, limited to cost of equipment, work-up and procedure to discharge, of IRE compared to prostatectomy (using medical records, information provided by equipment manufacturers, personnel involved, etc)

Timepoint [5]

At post-IRE procedure and post-prostatectomy procedure

Eligibility

Key inclusion criteria

1. 40 - 75 years 2. Histologically confirmed organ-confined prostate cancer (clinical stage T1-T2a) 3. Gleason score 7 (3+4 only) or less 4. PSA less than or equal to 10 ng/ml 5. No significant intravesical median lobe on ultrasound 6. Able to visualize prostate gland adequately on transrectal US imaging 7. No prostate calcification greater than 5 mm 8. Ability of subject to stop anticoagulant and anti-platelet therapy for 7 days prior and 7 days post procedure

Minimum age

40 Years

Maximum age

75 Years

Sex

Males

Can healthy volunteers participate?

Key exclusion criteria

1. <40, >75 years of age 2. High to medium risk subject with any one of the following: a) PSA greater than 10ng/ml, b) Gleason 7 (4+3 only) or greater, c) Positive bone scan 3. Other Conditions/Status a) Bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds, partial thromboplastin time (PTT) > 34 seconds, and platelet count < 140/uL b) Active urinary tract infection (“UTI”) c) History of bladder neck contracture d) Anaesthesia Surgical Assignment, category IV or greater e) Interest in future fertility f) History of inflammatory bowel disease g) Concurrent major debilitating illness h) Prior or concurrent malignancy 4. Prior or current therapies a) Biologic therapy for prostate cancer b) Chemotherapy for prostate cancer c) Hormonal therapy for prostate cancer within 3 months of procedure d) Radiotherapy for prostate cancer e) Transurethral prostatectomy (TURP), urethral stent f) Prior major rectal surgery (except haemorrhoids) g) Inability or unwillingness to tolerate temporary cessation of concurrent anticoagulation therapy or anti-platelet drugs for a period of 7days prior to procedure and up to 7 days after procedure

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Patients on the prostatectomy waiting list at The Alfred Hospital have a consultation with the hospital urologists prior to their procedure as part of standards of care. At their consultation potential participants will be told about the study and will be given a Participant Information and Consent form and the research coordinators contact number. They will be told that if they are intersted they should get in touch with the research coordinators. The coordinators will then organise a consultation with the study interventional radiologist who will explain the procedure and potential risks. Potential participants will be told to think about their voluntary participation and to discuss the study with their GP and family. If potential participants decide to take part an appointment will be made for them to be consented by the research coordinators.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Not applicable

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/05/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,VIC,ACT,QLD,SA,WA,NT,TAS

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Flack Trustees

Address [1]

Chairman of Trustees
The Marian & E. H. Flack Trust
PO Box 1473, East Camberwell, Vic 3126

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

Flack Trustees

Address

Chairman of Trustees
The Marian & E. H. Flack Trust
PO Box 1473, East Camberwell, Vic 3126

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Human Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/07/2011

Approval date [1]

Ethics approval number [1]

HREC No 159/11

Summary

Brief summary

Ablation techniques are used to directly destroy tumours within an organ. The location of the tumours is predetermined with imaging. With image guidance, needles are inserted through the skin (percutaneously) into the tumour and an energy field (heat, cold, microwaves, ultrasound etc) is used to destroy the tumour cells. Irreversible Electroporation (IRE) is a new ablation technology that has been shown to have advantages over other more established technologies. It uses high voltage direct electrical current to open the cell membranes and destroy tumours but spares surrounding tissues and vital structures such as nerves and blood vessels. The Study: Current surgical and ablative treatment options for prostate cancer have a relatively high incidence of side effects, mainly incontinence and erectile dysfunction, that diminish the quality of life of prostate cancer sufferers and impact on patients’ decision to undergo early, potentially curative treatments. These side effects are due to procedure related damage of the blood vessels, ureter and/or neurovascular bundle. New treatments that limit damage to these structures have the potential to improve patient outcomes. Ablation with Irreversible Electroporation (IRE) has been shown to be effective in destroying tumour cells and to have the advantage of sparing surrounding tissue and vital structures such as blood vessels and neurones. It is therefore postulated that this advantage may help reduce or avoid these side effects. The purpose of this study is to evaluate the safety, precision and cost of minimally invasive, percutaneous, image guided IRE for the ablation of prostate cancer. Who is it for? This study is eligible for up to six patients diagnosed with confirmed prostate cancer with no evidence of lymph node or distant metastases, categorised as low risk (as defined by the American Urological Association Guideline for Management of Clinically Localized Prostate Cancer: 2007 Update, as a clinical score of T1-2a, a Gleason score of 7 (3+4 only) or less, and a PSA less than or equal to 10 ng/ml) and scheduled for a radical prostatectomy by the treating urologist will have the IRE procedure 14-30 days before the prostatectomy. Participants will have preprocedure urological and prostate cancer assessments (Expanded Prostate Cancer Index Composite (EPIC) and International Prostate Symptom Score (IPSS). A specified ablation zone will be predetermined using the same preplanning used for conventional brachytherapy treatment. The procedure for planning and performing brachytherapy is well established in the Radiation Oncology Department at The Alfred. It involves determining the volume (size and shape) of the prostate. Trial Details In this study, you will undergo Irreversible Electroporation (IRE) procedure which involves two fine needle electrodes being placed percutaneously into the prostate in the same way as a biopsy is performed. An electric current is passed between the needle electrodes, which causes the pores of the cell membranes to open, thereby killing the cells. The procedure will take about an hour and a half, and will be performed by either the study urologist or study radiation oncologist with assistance with the technology by the study radiologists. You will then be followed up at 1, 2 and 4 weeks, where testing for any adverse events and urological and prostate assessments will be performed. When the prostate is removed it will be examined histologically (microscopically) to ascertain the effectiveness of ablation by the Anatomical Pathology Department at The Alfred. We will be able to know if complete ablation of the specified area was achieved.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Victoria Earl

Address

Radiology Research Unit
The Alfred
55 Commercial Road
Melbourne VIC 3004

Country

Australia

Phone

+61 3 9076 2126

Fax

[email protected]

Contact person for scientific queries

Name

Victoria Earl

Address

Radiology Research Unit
The Alfred
55 Commercial Road
Melbourne VIC 3004

Country

Australia

Phone

+61 3 9076 2126

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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