Prostate CancerNCT04278261
Comparison H-FIRE and Laparoscopic RP in Treating Men With Localized Prostate Cancer
A study testing Focal therapy(high-frequency irreversible electroporation) and laparoscopic radical prostatectomy in people with Prostate Cancer and Treatment, run by Shanghai East Hospital at 1 site in China.
Trial summary
This trial is comparing the functional and oncological outcomes in treating men with prostate cancer between high-frequency irreversible electroporation and laparoscopic radical prostatectomy. Read more about this study
- Who is it for?
- Ages Up to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Treatment
- What is being tested?
- Focal therapy(high-frequency irreversible electroporation) and laparoscopic radical prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 Sep 2026
- 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 Up to 80 years
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age less than 80 years old.
- PSA<20ng/ml.
- Clinical stage ≤T2c.
- Biopsy Gleason score ≤4+4.
- No evidence of metastasis.
- Fully understand the clinical trial protocol and sign the informed consent
Who cannot join
- Any previous treatment to PCa.
- Any previous surgery within 3 months.
- Contraindications to MRI, bone scan, or PSMA-PET (eg, metal implant, contrast agent allergy).
- History of any other malignant tumour.
- Any other conditions that make the investigator judge that participants are not suitable for this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, 200120
About this study
Official title: A Prospective, Single-center, Randomized Controlled Trial Comparing the Functional and Oncological Outcomes of High-frequency Irreversible Electroporation and Laparoscopic Radical Prostatectomy in Men With Localized Prostate Cancer
This trial is comparing the functional and oncological outcomes in treating men with prostate cancer between high-frequency irreversible electroporation and laparoscopic radical prostatectomy.
Read the detailed description
Two hundred and sixteen patients with localized prostate cancer will include in this study. The clinical trial validation process will be as follows: (1) all patients are randomly divided into two arms: arm 1, high-frequency irreversible electroporation; group 2, laparoscopic radical prostatectomy. The primary outcome is the urinary function and sexual function.
- Conditions
- Prostate Cancer, Treatment
- Being tested
- Focal therapy(high-frequency irreversible electroporation), laparoscopic radical prostatectomy
- Keywords
- Focal therapy, Radical prostatectomy, high-frequency Irreversible electroporation, 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.
Focal therapy(high-frequency irreversible electroporation)Procedure or surgery
High-frequency irreversible electroporation will be performed via the perineum with the guidance of ultrasound under general anaesthesia to the patient with localized prostate cancer
laparoscopic radical prostatectomyProcedure or surgery
Laparoscopic radical prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| Focal therapy | Experimental | Using focal therapy(high-frequency Irreversible electroporation) to treat patients with localized Prostate cancer Receives: Procedure: Focal therapy(high-frequency irreversible electroporation) |
| Radical prostatectomy | Active comparator | Using laparoscopic radical prostatectomy to treat patients with localized Prostate cancer Receives: Procedure: laparoscopic radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary function measured by ICIQ
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
Measured: 4 weeks
urinary function measured by ICIQ
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
Measured: 6 weeks
urinary function measured by ICIQ
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
Measured: 12 weeks
urinary function measured by ICIQ
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
Measured: 6 months
urinary function measured by ICIQ
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
Measured: 12 months
urinary function measured by ICIQ
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
Measured: 24 months
urinary function measured by EPIC
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
Measured: 4 weeks
urinary function measured by EPIC
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
Measured: 6 weeks
urinary function measured by EPIC
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
Measured: 12 weeks
urinary function measured by EPIC
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
Measured: 6 months
urinary function measured by EPIC
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
Measured: 12 months
urinary function measured by EPIC
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
Measured: 24 months
urinary function measured by separate EPIC pad-use item
The urinary function will be measured by a separate EPIC pad-use item
Measured: 4 weeks
urinary function measured by separate EPIC pad-use item
The urinary function will be measured by a separate EPIC pad-use item
Measured: 6 weeks
urinary function measured by separate EPIC pad-use item
The urinary function will be measured by a separate EPIC pad-use item
Measured: 12 weeks
urinary function measured by separate EPIC pad-use item
The urinary function will be measured by a separate EPIC pad-use item
Measured: 6 months
urinary function measured by separate EPIC pad-use item
The urinary function will be measured by a separate EPIC pad-use item
Measured: 12 months
urinary function measured by separate EPIC pad-use item
The urinary function will be measured by a separate EPIC pad-use item
Measured: 24 months
urinary function measured by IPSS
The urinary function will be measured by IPSS (International Prostate Symptom Score)
Measured: 4 weeks
urinary function measured by IPSS
The urinary function will be measured by IPSS (International Prostate Symptom Score)
Measured: 6 weeks
urinary function measured by IPSS
The urinary function will be measured by IPSS (International Prostate Symptom Score)
Measured: 12 weeks
urinary function measured by IPSS
The urinary function will be measured by IPSS (International Prostate Symptom Score)
Measured: 6 months
urinary function measured by IPSS
The urinary function will be measured by IPSS (International Prostate Symptom Score)
Measured: 12 months
urinary function measured by IPSS
The urinary function will be measured by IPSS (International Prostate Symptom Score)
Measured: 24 months
sexual function measured by EPIC
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
Measured: 4 weeks
sexual function measured by EPIC
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
Measured: 6 weeks
sexual function measured by EPIC
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
Measured: 12 weeks
sexual function measured by EPIC
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
Measured: 6 months
sexual function measured by EPIC
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
Measured: 12 months
sexual function measured by EPIC
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
Measured: 24 months
sexual function measured by IIEF-5
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
Measured: 4 weeks
sexual function measured by IIEF-5
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
Measured: 6 weeks
sexual function measured by IIEF-5
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
Measured: 12 weeks
sexual function measured by IIEF-5
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
Measured: 6 months
sexual function measured by IIEF-5
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
Measured: 12 months
sexual function measured by IIEF-5
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
Measured: 24 months
Secondary outcomes (56)
Number of patients with Disease progression
is defined either of the following items: (1) clinical evidence of progression (any of the positive results from the bone scan, pelvic MRI/CT, PSMA-PET MR/CT); (2) a positive biopsy (for the H-FIRE arm only); (3) biochemical failure (BCR, for the RP arm only, defined as a serum PSA level higher than 0.4 ng/ml after surgery)
Measured: 24 months
Bowel function
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Measured: 4 weeks
Bowel function
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Measured: 6 weeks
Bowel function
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Measured: 12 weeks
Bowel function
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Measured: 6 months
Bowel function
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Measured: 12 months
Bowel function
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Measured: 24 months
Quality of life measure by EORTC QLQ-C30
measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)
Measured: 4 weeks
Quality of life measure by EORTC QLQ-C30
measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)
Measured: 6 weeks
Quality of life measure by EORTC QLQ-C30
measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)
Measured: 12 weeks
Quality of life measure by EORTC QLQ-C30
measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)
Measured: 6 months
Quality of life measure by EORTC QLQ-C30
measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)
Measured: 12 months
Quality of life measure by EORTC QLQ-C30
measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)
Measured: 24 months
Quality of life measure by EPIC urinary domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Measured: 4 weeks
Quality of life measure by EPIC urinary domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Measured: 6 weeks
Quality of life measure by EPIC urinary domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Measured: 12 weeks
Quality of life measure by EPIC urinary domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Measured: 6 months
Quality of life measure by EPIC urinary domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Measured: 12 months
Quality of life measure by EPIC urinary domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Measured: 24 months
Quality of life measure by EPIC sexual domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Measured: 4 weeks
Quality of life measure by EPIC sexual domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Measured: 6 weeks
Quality of life measure by EPIC sexual domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Measured: 12 weeks
Quality of life measure by EPIC sexual domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Measured: 6 months
Quality of life measure by EPIC sexual domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Measured: 12 months
Quality of life measure by EPIC sexual domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Measured: 24 months
Quality of life measure by EPIC bowel domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Measured: 4 weeks
Quality of life measure by EPIC bowel domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Measured: 6 weeks
Quality of life measure by EPIC bowel domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Measured: 12 weeks
Quality of life measure by EPIC bowel domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Measured: 6 months
Quality of life measure by EPIC bowel domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Measured: 12 months
Quality of life measure by EPIC bowel domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Measured: 24 months
Quality of life measure by HADS
measured by Hospital Anxiety and Depression Scale (HADS)
Measured: 4 weeks
Quality of life measure by HADS
measured by Hospital Anxiety and Depression Scale (HADS)
Measured: 6 weeks
Quality of life measure by HADS
measured by Hospital Anxiety and Depression Scale (HADS)
Measured: 12 weeks
Quality of life measure by HADS
measured by Hospital Anxiety and Depression Scale (HADS)
Measured: 6 months
Quality of life measure by HADS
measured by Hospital Anxiety and Depression Scale (HADS)
Measured: 12 months
Quality of life measure by HADS
measured by Hospital Anxiety and Depression Scale (HADS)
Measured: 24 months
Rates of primary treatment failure
defined as biopsy show cancer remain at 6 months after H-FIRE procedure, or a PSA level 0.4ng/ml or higher at 3 months after RP procedure
Measured: 24 months
Rates of adjuvant therapy
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Measured: 4 weeks
Rates of adjuvant therapy
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Measured: 6 weeks
Rates of adjuvant therapy
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Measured: 12 weeks
Rates of adjuvant therapy
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Measured: 6 months
Rates of adjuvant therapy
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Measured: 12 months
Rates of adjuvant therapy
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Measured: 24 months
Perioperative data (operative time)
operative time
Measured: 1 month
Perioperative data (hemoglobin loss)
hemoglobin loss
Measured: 1 month
Perioperative data (blood transfusion)
the number of patients need blood transfusion
Measured: 1 month
Perioperative data (the length of hospital stay)
the length of hospital stay
Measured: 1 month
Perioperative data(the length of indwelling catheter stay)
the length of indwelling catheter stay
Measured: 1 month
Pain (measured by a surgical pain scale range from 0 to 10)
measured by a surgical pain scale range from 0 to 10
Measured: 24 hours
Pain (measured by a surgical pain scale range from 0 to 10)
measured by a surgical pain scale range from 0 to 10
Measured: 2 weeks
Pain (measured by a surgical pain scale range from 0 to 10)
measured by a surgical pain scale range from 0 to 10
Measured: 4 weeks
Pain (measured by a surgical pain scale range from 0 to 10)
measured by a surgical pain scale range from 0 to 10
Measured: 6 weeks
Pain (measured by a surgical pain scale range from 0 to 10)
measured by a surgical pain scale range from 0 to 10
Measured: 12 weeks
Pain (measured by a surgical pain scale range from 0 to 10)
measured by a surgical pain scale range from 0 to 10
Measured: 6 months
Adverse effect
identified by the Common Terminology Criteria for Adverse Events (CTCAE)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haifeng Wang, MD, Principal investigator, Shanghai East Hospital of Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278261
- Sponsor's protocol ID
- HIRE-FR-2019001
- Status last verified
- May 2022
- First submitted
- 19 Feb 2020
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Randomized Controlled Trial Comparing the Functional and Oncological Outcomes of High-frequency Irreversible Electroporation and Laparoscopic Radical Prostatectomy in Men With Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT04278261
- Acronym / sponsor ID
- HIRE-FR-2019001
- Conditions
- Prostate Cancer, Treatment
- Keywords
- Focal therapy, Radical prostatectomy, high-frequency Irreversible electroporation, prostate cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 20 Feb 2020 (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 comparing the functional and oncological outcomes in treating men with prostate cancer between high-frequency irreversible electroporation and laparoscopic radical prostatectomy.
Detailed description
Two hundred and sixteen patients with localized prostate cancer will include in this study. The clinical trial validation process will be as follows: (1) all patients are randomly divided into two arms: arm 1, high-frequency irreversible electroporation; group 2, laparoscopic radical prostatectomy. The primary outcome is the urinary function and sexual function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focal therapy | Experimental | Procedure: Focal therapy(high-frequency irreversible electroporation)Using focal therapy(high-frequency Irreversible electroporation) to treat patients with localized Prostate cancer |
| Radical prostatectomy | Active comparator | Procedure: laparoscopic radical prostatectomyUsing laparoscopic radical prostatectomy to treat patients with localized Prostate cancer |
Who may qualify
- Ages
- Up to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age less than 80 years old.
- PSA<20ng/ml.
- Clinical stage ≤T2c.
- Biopsy Gleason score ≤4+4.
- No evidence of metastasis.
Key exclusion criteria (5 listed)
- Any previous treatment to PCa.
- Any previous surgery within 3 months.
- Contraindications to MRI, bone scan, or PSMA-PET (eg, metal implant, contrast agent allergy).
- History of any other malignant tumour.
- Any other conditions that make the investigator judge that participants are not suitable for this trial.
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 |
|---|---|---|
| Focal therapy(high-frequency irreversible electroporation)High-frequency irreversible electroporation will be performed via the perineum with the guidance of ultrasound under general anaesthesia to the patient with localized prostate cancer | Procedure or surgery | Focal therapy |
| laparoscopic radical prostatectomyLaparoscopic radical prostatectomy | Procedure or surgery | Radical prostatectomy |
Primary outcome
urinary function measured by ICIQ
Time frame: 4 weeks
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
urinary function measured by ICIQ
Time frame: 6 weeks
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
urinary function measured by ICIQ
Time frame: 12 weeks
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
urinary function measured by ICIQ
Time frame: 6 months
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
urinary function measured by ICIQ
Time frame: 12 months
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
urinary function measured by ICIQ
Time frame: 24 months
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
urinary function measured by EPIC
Time frame: 4 weeks
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
urinary function measured by EPIC
Time frame: 6 weeks
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
urinary function measured by EPIC
Time frame: 12 weeks
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
urinary function measured by EPIC
Time frame: 6 months
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
urinary function measured by EPIC
Time frame: 12 months
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
urinary function measured by EPIC
Time frame: 24 months
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
urinary function measured by separate EPIC pad-use item
Time frame: 4 weeks
The urinary function will be measured by a separate EPIC pad-use item
urinary function measured by separate EPIC pad-use item
Time frame: 6 weeks
The urinary function will be measured by a separate EPIC pad-use item
urinary function measured by separate EPIC pad-use item
Time frame: 12 weeks
The urinary function will be measured by a separate EPIC pad-use item
urinary function measured by separate EPIC pad-use item
Time frame: 6 months
The urinary function will be measured by a separate EPIC pad-use item
urinary function measured by separate EPIC pad-use item
Time frame: 12 months
The urinary function will be measured by a separate EPIC pad-use item
urinary function measured by separate EPIC pad-use item
Time frame: 24 months
The urinary function will be measured by a separate EPIC pad-use item
urinary function measured by IPSS
Time frame: 4 weeks
The urinary function will be measured by IPSS (International Prostate Symptom Score)
urinary function measured by IPSS
Time frame: 6 weeks
The urinary function will be measured by IPSS (International Prostate Symptom Score)
urinary function measured by IPSS
Time frame: 12 weeks
The urinary function will be measured by IPSS (International Prostate Symptom Score)
urinary function measured by IPSS
Time frame: 6 months
The urinary function will be measured by IPSS (International Prostate Symptom Score)
urinary function measured by IPSS
Time frame: 12 months
The urinary function will be measured by IPSS (International Prostate Symptom Score)
urinary function measured by IPSS
Time frame: 24 months
The urinary function will be measured by IPSS (International Prostate Symptom Score)
sexual function measured by EPIC
Time frame: 4 weeks
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
sexual function measured by EPIC
Time frame: 6 weeks
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
sexual function measured by EPIC
Time frame: 12 weeks
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
sexual function measured by EPIC
Time frame: 6 months
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
sexual function measured by EPIC
Time frame: 12 months
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
sexual function measured by EPIC
Time frame: 24 months
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
sexual function measured by IIEF-5
Time frame: 4 weeks
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
sexual function measured by IIEF-5
Time frame: 6 weeks
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
sexual function measured by IIEF-5
Time frame: 12 weeks
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
sexual function measured by IIEF-5
Time frame: 6 months
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
sexual function measured by IIEF-5
Time frame: 12 months
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
sexual function measured by IIEF-5
Time frame: 24 months
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
56 secondary outcomes
Number of patients with Disease progression
Time frame: 24 months
Bowel function
Time frame: 4 weeks
Bowel function
Time frame: 6 weeks
Bowel function
Time frame: 12 weeks
Bowel function
Time frame: 6 months
Bowel function
Time frame: 12 months
Bowel function
Time frame: 24 months
Quality of life measure by EORTC QLQ-C30
Time frame: 4 weeks
Quality of life measure by EORTC QLQ-C30
Time frame: 6 weeks
Quality of life measure by EORTC QLQ-C30
Time frame: 12 weeks
Quality of life measure by EORTC QLQ-C30
Time frame: 6 months
Quality of life measure by EORTC QLQ-C30
Time frame: 12 months
Quality of life measure by EORTC QLQ-C30
Time frame: 24 months
Quality of life measure by EPIC urinary domain bother score
Time frame: 4 weeks
Quality of life measure by EPIC urinary domain bother score
Time frame: 6 weeks
Quality of life measure by EPIC urinary domain bother score
Time frame: 12 weeks
Quality of life measure by EPIC urinary domain bother score
Time frame: 6 months
Quality of life measure by EPIC urinary domain bother score
Time frame: 12 months
Quality of life measure by EPIC urinary domain bother score
Time frame: 24 months
Quality of life measure by EPIC sexual domain bother score
Time frame: 4 weeks
Quality of life measure by EPIC sexual domain bother score
Time frame: 6 weeks
Quality of life measure by EPIC sexual domain bother score
Time frame: 12 weeks
Quality of life measure by EPIC sexual domain bother score
Time frame: 6 months
Quality of life measure by EPIC sexual domain bother score
Time frame: 12 months
Quality of life measure by EPIC sexual domain bother score
Time frame: 24 months
Quality of life measure by EPIC bowel domain bother score
Time frame: 4 weeks
Quality of life measure by EPIC bowel domain bother score
Time frame: 6 weeks
Quality of life measure by EPIC bowel domain bother score
Time frame: 12 weeks
Quality of life measure by EPIC bowel domain bother score
Time frame: 6 months
Quality of life measure by EPIC bowel domain bother score
Time frame: 12 months
Quality of life measure by EPIC bowel domain bother score
Time frame: 24 months
Quality of life measure by HADS
Time frame: 4 weeks
Quality of life measure by HADS
Time frame: 6 weeks
Quality of life measure by HADS
Time frame: 12 weeks
Quality of life measure by HADS
Time frame: 6 months
Quality of life measure by HADS
Time frame: 12 months
Quality of life measure by HADS
Time frame: 24 months
Rates of primary treatment failure
Time frame: 24 months
Rates of adjuvant therapy
Time frame: 4 weeks
Rates of adjuvant therapy
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Not yet recruitingObservational study
Assessment of Intelligent Algorithms for Detection, Diagnosis and Risk Stratification of Tumors of the Kidney and Prostate
Kidney Cancers, Prostate Cancer
Not yet recruiting
WATER IV PCa (AS Sub-study)
Localized Prostate Cancer
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingPhase 1
A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer
Castration Resistant Metastatic Prostate Cancer, Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
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.
Haifeng Wang, MD principal investigator
Shanghai East Hospital of Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focal therapy(high-frequency irreversible electroporation) and laparoscopic radical prostatectomy in people with Prostate Cancer and Treatment, run by Shanghai East Hospital 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Biming He, MD (+8615502139410, 190589109@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urinary function measured by ICIQ (time frame: 4 weeks). The study lists 36 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 2 Jun 2022.