Prostate CancerNCT03315585
The Efficacy and Safety of Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Focal Therapy
A study testing steep pulse device in people with Prostate Cancer, run by Second Military Medical University at 1 site in China.
Trial summary
This trial is studying the effects and safety in treating patients with local prostate cancer with a new IRE device called Composite Steep-pulse Treatment Apparatus. This new device could cause cell irreversible electroporation, which leading necrosis of tumor cells. Read more about this study
- Who is it for?
- Ages 30 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- steep pulse device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2017to 27 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Prostate MRI can identify the suspect region(pi-RADS≥4 ) ,and no evidence of lymphatic metastasis
- Patients must have confirmed prostate cancer by prostate biopsy
- There must be no evidence of metastatic disease as confirmed by ECT and whole-body MRI
- No prostatic calculus or prostatic calculus≤5mm
- No contraindication on total intravenous anesthesia
- Not take any anticoagulants before or discontinue anticoagulant therapy at least 7 days
Show all 10Show fewer
- Age ≥ 30 - ≤ 75 years
- Life expectancy of greater than 10 years
- Patients scheduled for radical prostatectomy.
- Sexually potent
Who cannot join
- Patients have previously undergone radical prostatectomy.
- Patients have previously undergone hormonal therapy or radiotherapy.
- Patients underwent other surgery before less than 3 months
- Clinically significant cardiovascular disease
- Patients with other malignant tumor or patients with hiv.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients with poor health condition
- Simultaneous participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
Changhai Hospital,Second Military Medical University
Shanghai, Shanghai Municipality, 200000
About this study
Official title: The Efficacy and Safety of Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Focal therapy-a Phase I Study
This trial is studying the effects and safety in treating patients with local prostate cancer with a new IRE device called Composite Steep-pulse Treatment Apparatus. This new device could cause cell irreversible electroporation, which leading necrosis of tumor cells. It also has the ability to prevent nerve,vessel, urethral and capsule unnecessary injury beside the ablation area. Composite Steep-pulse Treatment Apparatus will be used in patients who pass inclusion/exclusion criteria. Safety, quality of life, and histopathological analysis of prostate speciem will be evaluated in each study patients.
Read the detailed description
Background:
Prostate cancer is the most common cancer in elderly males in western country. It is also a major health concern, especially in China with its greater proportion of elderly men in the general population. Currently, radical prostatectomy(RP) is the mainstream treatment for localized PCa to show a benefit for cancer-specific survival (CSS). However, the patient who underwent RP might suffer from the complication of erectile dysfunction or urinary incontinence. In 2004, a new method using steep pulses to treat tumor was appeared. It showed that steep pulses could bring about Irreversible Electroporation (IRE) of cell, leading tonecrosis of tumor cells. And it seemed to do no harms to the nerve and Vascular epithelial cell. The device of steep pulse had already been approved by FDA in 2011.However, this device of steep pulse has disadvantages like: (1)sever muscle contraction;(2)Urethral injury; (3)Capsule injury;(4)Nerve degeneration. This new device which is called Composite Steep-pulse Treatment Apparatus, may have the potential to conquer these disadvantages.
Purpose:
- This study will assess the efficacy of Composite Steep-pulse Treatment Apparatus in the treatment of PCa.
- This study will assess potency, urinary continence and complication rate for the patients undergo the treatment with steep pulse device.
- Histopathological analysis of prostate speciem 4 weeks after treated by Composite Steep-pulse Treatment Apparatus.
Methods:
- patients recruitment
- transperineal prostate targeted biopsy guided by multiparametric magnetic resonance imaging/transrectal ultrasound (mpMRI/TRUS) fusion, plus systemic prostate biopsy.
- Frozen pathological analysis will be performed;
- Irreversible Electroporation of malignant Tumor Cell under Composite Steep-pulse Treatment for the patients with positive biopsy;
- Complication, urinary continence, and sexual function will be evaluated after the IRE treatment;
- RP for these patients in 4 weeks after the treatment of Composite Steep-pulse Treatment.
- Histopathological Outcomes analysis will be performed to evaluate tumor residual rate, urethral injuries, nerve injuries and capsule injury in and beside the ablation area.
- Conditions
- Prostate Cancer
- Being tested
- steep pulse device
- Keywords
- focal therapy, IRE, Composite Steep-pulse Treatment Apparatus, prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
steep pulse deviceDevice
Applying the steep pulse to treat the patients with Prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| Steep Pulse Device | Experimental | Applying the steep pulse to treat the patients with Prostate cancer Receives: Device: steep pulse device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IRE(with Composite Steep-pulse Treatment Apparatus) ablation procedure
To determine if the IRE(with Composite Steep-pulse Treatment Apparatus) ablation procedure is safe as measured by the composite number of procedural, device and post procedural adverse events measured with the CTCAE proforma.
Measured: 1 Year
Efficacy (persentage of unablated tissue un the ablation zone)
Persentage of normal glandular tissue in the specified targeted ablation zone by histopathology assessment
Measured: 1 month
Secondary outcomes (2)
Sexual function
Mean sexual function domain score (IIEF-5 scoring:
The IIEF-5 score is the sum of the ordinal responses to the 5 items. 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction)
Measured: 1 month
Urinary incontinence
Mean urinary incontinence domain score (the number of pad everyday,good is less than 2 pads a day, more or equal than 2 pads a day)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start27 Apr 2017
- Primary completion27 Oct 2017
- Study completion27 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yinghao Sun, Second Military Medical University
- Investigators
- yinghao sun, MD,PHD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315585
- Sponsor's protocol ID
- REMD-FA2017001
- Status last verified
- Apr 2018
- First submitted
- 2 Jul 2017
- Last updated
- 13 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Focal therapy-a Phase I Study
- ClinicalTrials.gov ID
- NCT03315585
- Acronym / sponsor ID
- REMD-FA2017001
- Conditions
- Prostate Cancer
- Keywords
- focal therapy, IRE, Composite Steep-pulse Treatment Apparatus, prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Second Military Medical UniversityUniversity, hospital or other
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is studying the effects and safety in treating patients with local prostate cancer with a new IRE device called Composite Steep-pulse Treatment Apparatus. This new device could cause cell irreversible electroporation, which leading necrosis of tumor cells. It also has the ability to prevent nerve,vessel, urethral and capsule unnecessary injury beside the ablation area. Composite Steep-pulse Treatment Apparatus will be used in patients who pass inclusion/exclusion criteria. Safety, quality of life, and histopathological analysis of prostate speciem will be evaluated in each study patients.
Detailed description
Background:
Prostate cancer is the most common cancer in elderly males in western country. It is also a major health concern, especially in China with its greater proportion of elderly men in the general population. Currently, radical prostatectomy(RP) is the mainstream treatment for localized PCa to show a benefit for cancer-specific survival (CSS). However, the patient who underwent RP might suffer from the complication of erectile dysfunction or urinary incontinence. In 2004, a new method using steep pulses to treat tumor was appeared. It showed that steep pulses could bring about Irreversible Electroporation (IRE) of cell, leading tonecrosis of tumor cells. And it seemed to do no harms to the nerve and Vascular epithelial cell. The device of steep pulse had already been approved by FDA in 2011.However, this device of steep pulse has disadvantages like: (1)sever muscle contraction;(2)Urethral injury; (3)Capsule injury;(4)Nerve degeneration. This new device which is called Composite Steep-pulse Treatment Apparatus, may have the potential to conquer these disadvantages.
Purpose:
- This study will assess the efficacy of Composite Steep-pulse Treatment Apparatus in the treatment of PCa.
- This study will assess potency, urinary continence and complication rate for the patients undergo the treatment with steep pulse device.
- Histopathological analysis of prostate speciem 4 weeks after treated by Composite Steep-pulse Treatment Apparatus.
Methods:
- patients recruitment
- transperineal prostate targeted biopsy guided by multiparametric magnetic resonance imaging/transrectal ultrasound (mpMRI/TRUS) fusion, plus systemic prostate biopsy.
- Frozen pathological analysis will be performed;
- Irreversible Electroporation of malignant Tumor Cell under Composite Steep-pulse Treatment for the patients with positive biopsy;
- Complication, urinary continence, and sexual function will be evaluated after the IRE treatment;
- RP for these patients in 4 weeks after the treatment of Composite Steep-pulse Treatment.
- Histopathological Outcomes analysis will be performed to evaluate tumor residual rate, urethral injuries, nerve injuries and capsule injury in and beside the ablation area.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Steep Pulse Device | Experimental | Device: steep pulse deviceApplying the steep pulse to treat the patients with Prostate cancer |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Prostate MRI can identify the suspect region(pi-RADS≥4 ) ,and no evidence of lymphatic metastasis
- Patients must have confirmed prostate cancer by prostate biopsy
- There must be no evidence of metastatic disease as confirmed by ECT and whole-body MRI
- No prostatic calculus or prostatic calculus≤5mm
- No contraindication on total intravenous anesthesia
Key exclusion criteria (8 listed)
- Patients have previously undergone radical prostatectomy.
- Patients have previously undergone hormonal therapy or radiotherapy.
- Patients underwent other surgery before less than 3 months
- Clinically significant cardiovascular disease
- Patients with other malignant tumor or patients with hiv.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| steep pulse deviceApplying the steep pulse to treat the patients with Prostate cancer | Device | Steep Pulse Device |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IRE(with Composite Steep-pulse Treatment Apparatus) ablation procedure
Time frame: 1 Year
To determine if the IRE(with Composite Steep-pulse Treatment Apparatus) ablation procedure is safe as measured by the composite number of procedural, device and post procedural adverse events measured with the CTCAE proforma.
Efficacy (persentage of unablated tissue un the ablation zone)
Time frame: 1 month
Persentage of normal glandular tissue in the specified targeted ablation zone by histopathology assessment
2 secondary outcomes
Sexual function
Time frame: 1 month
Urinary incontinence
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yinghao sun, MD,PHD principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing steep pulse device in people with Prostate Cancer, run by Second Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IRE(with Composite Steep-pulse Treatment Apparatus) ablation procedure (time frame: 1 Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.