To evaluate the safety, efficacy and to acquire data on patient experience of minimally invasive, percutaneous, image guided IRE for the ablation of prostate cancer.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
a) To determine if the IRE ablation procedure is safe as measured by the
composite number of procedural, device and post procedural adverse events
measured with the CTCAE proforma.
b) To determine if complete ablation of the specified targeted ablation zone is
achieved as measured by histopathology assessment.
Secondary outcome
a) 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 *EPIC, IIEF-5
and IPSS or time of CAD required.
b) To determine patient satisfaction and comfort measured by Patient
Satisfaction Questionnaire, post procedural pain management and pain scores,
time to ambulation, length of hospital stay.
c) To determine accurateness of ablation zone detection by MRI/CEUS.
Background summary
Current surgical and ablative treatment options for prostate cancer have a
relatively high incidence, up to 90%, of incontinence, erectile dysfunction and
bowel damage. These side effects 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, bowel, urethra 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.
Study objective
To evaluate the safety, efficacy and to acquire data on patient experience of
minimally invasive, percutaneous, image guided IRE for the ablation of prostate
cancer.
Study design
Prospective Human In-Vivo study: Up to 16 patients with confirmed low- or
intermediate risk prostate cancer scheduled for a radical prostatectomy will be
asked to have the IRE procedure approximately 30 days prior to the
prostatectomy. Ablation with IRE will be performed using similar planning
criteria, procedure protocol, instruments and software used for brachytherapy.
Patients will have an ultrasound of the prostate and the imaging data will be
entered into the Planning Software system. The patients will be admitted for
overnight stay in the hospital on the morning of the scheduled IRE procedure.
The IRE will be performed under general anaesthetic and the specified zone
identified in the planning stage will be ablated. Safety data will be collected
and patients will be followed up at 1 week, 2 weeks post IRE, pre-
prostatectomy, post prostatectomy and 1 week post prostatectomy. The safety
data collection is at 2 weeks post IRE. Before the prostatectomy patients will
have a MRI and CEUS of the prostate. The patients will have their scheduled
prostatectomy at approximately 30 days after the IRE procedure.
Pre-prostatectomy, the ablation zone will be radiologically assessed by
MRI/CEUS. Post prostatectomy, efficacy of ablation will be determined by
histological examination of the prostate by the AMC Pathology Department and
measured as complete or incomplete ablation.
The primary outcome is safety as measured by the composite of procedural device
and post procedural adverse events, measured with the Common Terminology
Criteria for Adverse Events v 4 (CTCAE), Expanded Prostate Cancer Index
Composite (EPIC) score, International Prostate Symptom Score (IPSS) or required
catheterization time and International Index of Erectile Function (IIEF) and
efficacy of ablation determined by histological examination post prostatectomy.
Secondary outcomes will be patient*s procedure satisfaction measured by patient
satisfaction questionnaire, post procedural pain management and pain scores,
time to ambulation, length of hospital stay.
Intervention
Ablation with IRE will be performed using similar planning criteria, procedure
protocol, instruments and software used for brachytherapy, a conventional
targeted radiation therapy where radioactive seeds are implanted into prostate
tumours. Patients will have an ultrasound of the prostate and the imaging data
will be entered into the Planning Software system. The volume of the prostate
is measured and a specified ablation zone will be determined. The patients will
be admitted for overnight stay in the hospital on the morning of the scheduled
IRE procedure. The IRE will be performed under general anaesthetic and the
specified zone identified in the planning stage will be ablated. Two IRE
electrode needles will be placed into the prostate under ultrasound image
guidance. When the needles are in place, electric pulses of one to two minutes
duration are used to ablate the specified zone. The total procedure time will
be approximately 1 hour.
Study burden and risks
Electroporation is a technology that sends high voltage direct current pulses
through the prostate. These pulses function in between the two electrodes and
therefore work locally. However, in patients with a cardiac premedical history,
there is a possibility that they can cause an arrhythmia. Therefore, these
patients are excluded from the study. Further potential risks and danger are:
Infection, bleeding, (temporarily) anuria requiring catheterization, urethral
stricture, (temporarily) pain in the treated area, (temporarily) hematuria,
(temporarily) zwelling of the scrotum, (temporarily) incontinence.
There is no direct advantage for the patient to take part in this study. The
advantage of participation is the knowledge that people in the future can
receive a tailored treatment for prostate cancer with less side effects. For
this study, an extra intervention under narcosis is required. The risk are
limited, because the prostate will be removed in toto 4 weeks after treatment.
The study is of great importance for validation of the technology for prostate
cancer treatment.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
1. Life expectancy > 10 years
2. Histologically confirmed organ-confined prostate cancer (clinical stage T1-T2)
3. Gleason score *7
4. PSA <20 ng/ml
5. Able to visualize prostate gland adequately on transrectal US imaging
6. No prostate calcification greater than 5 mm
7. Ability of subject to stop anticoagulant and anti-platelet therapy for 7 days prior and 7 days post procedure
Exclusion criteria
1. 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
e) History of inflammatory bowel disease
f) Concurrent major debilitating illness
g) Prior or concurrent malignancy
h) Cardiac History
i) ICD / Pacemaker
2. 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40870.018.12 |