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Comparison H-FIRE and Laparoscopic RP in Treating Men With Localized Prostate Cancer

Primary Purpose

Prostate Cancer, Treatment

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Focal therapy(high-frequency irreversible electroporation)
laparoscopic radical prostatectomy
Sponsored by
Shanghai East Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Focal therapy, Radical prostatectomy, high-frequency Irreversible electroporation, prostate cancer

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age less than 80 years old.
  2. PSA<20ng/ml.
  3. Clinical stage ≤T2c.
  4. Biopsy Gleason score ≤4+4.
  5. No evidence of metastasis.
  6. Fully understand the clinical trial protocol and sign the informed consent

Exclusion Criteria:

  1. Any previous treatment to PCa.
  2. Any previous surgery within 3 months.
  3. Contraindications to MRI, bone scan, or PSMA-PET (eg, metal implant, contrast agent allergy).
  4. History of any other malignant tumour.
  5. Any other conditions that make the investigator judge that participants are not suitable for this trial.

Sites / Locations

  • Shanghai East Hospital, Tongji University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Focal therapy

Radical prostatectomy

Arm Description

Using focal therapy(high-frequency Irreversible electroporation) to treat patients with localized Prostate cancer

Using laparoscopic radical prostatectomy to treat patients with localized Prostate cancer

Outcomes

Primary Outcome Measures

urinary function measured by ICIQ
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
urinary function measured by ICIQ
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
urinary function measured by ICIQ
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
urinary function measured by ICIQ
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
urinary function measured by ICIQ
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
urinary function measured by ICIQ
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
urinary function measured by EPIC
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
urinary function measured by EPIC
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
urinary function measured by EPIC
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
urinary function measured by EPIC
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
urinary function measured by EPIC
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
urinary function measured by EPIC
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
The urinary function will be measured by a separate EPIC pad-use item
urinary function measured by separate EPIC pad-use item
The urinary function will be measured by a separate EPIC pad-use item
urinary function measured by separate EPIC pad-use item
The urinary function will be measured by a separate EPIC pad-use item
urinary function measured by separate EPIC pad-use item
The urinary function will be measured by a separate EPIC pad-use item
urinary function measured by separate EPIC pad-use item
The urinary function will be measured by a separate EPIC pad-use item
urinary function measured by separate EPIC pad-use item
The urinary function will be measured by a separate EPIC pad-use item
urinary function measured by IPSS
The urinary function will be measured by IPSS (International Prostate Symptom Score)
urinary function measured by IPSS
The urinary function will be measured by IPSS (International Prostate Symptom Score)
urinary function measured by IPSS
The urinary function will be measured by IPSS (International Prostate Symptom Score)
urinary function measured by IPSS
The urinary function will be measured by IPSS (International Prostate Symptom Score)
urinary function measured by IPSS
The urinary function will be measured by IPSS (International Prostate Symptom Score)
urinary function measured by IPSS
The urinary function will be measured by IPSS (International Prostate Symptom Score)
sexual function measured by EPIC
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
sexual function measured by EPIC
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
sexual function measured by EPIC
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
sexual function measured by EPIC
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
sexual function measured by EPIC
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
sexual function measured by EPIC
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
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)
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)
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)
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)
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)
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)

Secondary Outcome Measures

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)
Bowel function
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Bowel function
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Bowel function
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Bowel function
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Bowel function
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Bowel function
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
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)
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)
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)
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)
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)
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)
Quality of life measure by EPIC urinary domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Quality of life measure by EPIC urinary domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Quality of life measure by EPIC urinary domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Quality of life measure by EPIC urinary domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Quality of life measure by EPIC urinary domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Quality of life measure by EPIC urinary domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Quality of life measure by EPIC sexual domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Quality of life measure by EPIC sexual domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Quality of life measure by EPIC sexual domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Quality of life measure by EPIC sexual domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Quality of life measure by EPIC sexual domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Quality of life measure by EPIC sexual domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Quality of life measure by EPIC bowel domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Quality of life measure by EPIC bowel domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Quality of life measure by EPIC bowel domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Quality of life measure by EPIC bowel domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Quality of life measure by EPIC bowel domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Quality of life measure by EPIC bowel domain bother score
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Quality of life measure by HADS
measured by Hospital Anxiety and Depression Scale (HADS)
Quality of life measure by HADS
measured by Hospital Anxiety and Depression Scale (HADS)
Quality of life measure by HADS
measured by Hospital Anxiety and Depression Scale (HADS)
Quality of life measure by HADS
measured by Hospital Anxiety and Depression Scale (HADS)
Quality of life measure by HADS
measured by Hospital Anxiety and Depression Scale (HADS)
Quality of life measure by HADS
measured by Hospital Anxiety and Depression Scale (HADS)
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
Rates of adjuvant therapy
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Rates of adjuvant therapy
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Rates of adjuvant therapy
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Rates of adjuvant therapy
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Rates of adjuvant therapy
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Rates of adjuvant therapy
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Perioperative data (operative time)
operative time
Perioperative data (hemoglobin loss)
hemoglobin loss
Perioperative data (blood transfusion)
the number of patients need blood transfusion
Perioperative data (the length of hospital stay)
the length of hospital stay
Perioperative data(the length of indwelling catheter stay)
the length of indwelling catheter stay
Pain (measured by a surgical pain scale range from 0 to 10)
measured by a surgical pain scale range from 0 to 10
Pain (measured by a surgical pain scale range from 0 to 10)
measured by a surgical pain scale range from 0 to 10
Pain (measured by a surgical pain scale range from 0 to 10)
measured by a surgical pain scale range from 0 to 10
Pain (measured by a surgical pain scale range from 0 to 10)
measured by a surgical pain scale range from 0 to 10
Pain (measured by a surgical pain scale range from 0 to 10)
measured by a surgical pain scale range from 0 to 10
Pain (measured by a surgical pain scale range from 0 to 10)
measured by a surgical pain scale range from 0 to 10
Adverse effect
identified by the Common Terminology Criteria for Adverse Events (CTCAE)

Full Information

First Posted
February 19, 2020
Last Updated
May 30, 2022
Sponsor
Shanghai East Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04278261
Brief Title
Comparison H-FIRE and Laparoscopic RP in Treating Men With Localized Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
July 1, 2026 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai East Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Treatment
Keywords
Focal therapy, Radical prostatectomy, high-frequency Irreversible electroporation, prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Focal therapy
Arm Type
Experimental
Arm Description
Using focal therapy(high-frequency Irreversible electroporation) to treat patients with localized Prostate cancer
Arm Title
Radical prostatectomy
Arm Type
Active Comparator
Arm Description
Using laparoscopic radical prostatectomy to treat patients with localized Prostate cancer
Intervention Type
Procedure
Intervention Name(s)
Focal therapy(high-frequency irreversible electroporation)
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
laparoscopic radical prostatectomy
Intervention Description
Laparoscopic radical prostatectomy
Primary Outcome Measure Information:
Title
urinary function measured by ICIQ
Description
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
Time Frame
4 weeks
Title
urinary function measured by ICIQ
Description
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
Time Frame
6 weeks
Title
urinary function measured by ICIQ
Description
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
Time Frame
12 weeks
Title
urinary function measured by ICIQ
Description
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
Time Frame
6 months
Title
urinary function measured by ICIQ
Description
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
Time Frame
12 months
Title
urinary function measured by ICIQ
Description
The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score
Time Frame
24 months
Title
urinary function measured by EPIC
Description
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
Time Frame
4 weeks
Title
urinary function measured by EPIC
Description
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
Time Frame
6 weeks
Title
urinary function measured by EPIC
Description
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
Time Frame
12 weeks
Title
urinary function measured by EPIC
Description
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
Time Frame
6 months
Title
urinary function measured by EPIC
Description
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
Time Frame
12 months
Title
urinary function measured by EPIC
Description
The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score
Time Frame
24 months
Title
urinary function measured by separate EPIC pad-use item
Description
The urinary function will be measured by a separate EPIC pad-use item
Time Frame
4 weeks
Title
urinary function measured by separate EPIC pad-use item
Description
The urinary function will be measured by a separate EPIC pad-use item
Time Frame
6 weeks
Title
urinary function measured by separate EPIC pad-use item
Description
The urinary function will be measured by a separate EPIC pad-use item
Time Frame
12 weeks
Title
urinary function measured by separate EPIC pad-use item
Description
The urinary function will be measured by a separate EPIC pad-use item
Time Frame
6 months
Title
urinary function measured by separate EPIC pad-use item
Description
The urinary function will be measured by a separate EPIC pad-use item
Time Frame
12 months
Title
urinary function measured by separate EPIC pad-use item
Description
The urinary function will be measured by a separate EPIC pad-use item
Time Frame
24 months
Title
urinary function measured by IPSS
Description
The urinary function will be measured by IPSS (International Prostate Symptom Score)
Time Frame
4 weeks
Title
urinary function measured by IPSS
Description
The urinary function will be measured by IPSS (International Prostate Symptom Score)
Time Frame
6 weeks
Title
urinary function measured by IPSS
Description
The urinary function will be measured by IPSS (International Prostate Symptom Score)
Time Frame
12 weeks
Title
urinary function measured by IPSS
Description
The urinary function will be measured by IPSS (International Prostate Symptom Score)
Time Frame
6 months
Title
urinary function measured by IPSS
Description
The urinary function will be measured by IPSS (International Prostate Symptom Score)
Time Frame
12 months
Title
urinary function measured by IPSS
Description
The urinary function will be measured by IPSS (International Prostate Symptom Score)
Time Frame
24 months
Title
sexual function measured by EPIC
Description
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
Time Frame
4 weeks
Title
sexual function measured by EPIC
Description
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
Time Frame
6 weeks
Title
sexual function measured by EPIC
Description
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
Time Frame
12 weeks
Title
sexual function measured by EPIC
Description
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
Time Frame
6 months
Title
sexual function measured by EPIC
Description
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
Time Frame
12 months
Title
sexual function measured by EPIC
Description
The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score
Time Frame
24 months
Title
sexual function measured by IIEF-5
Description
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
Time Frame
4 weeks
Title
sexual function measured by IIEF-5
Description
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
Time Frame
6 weeks
Title
sexual function measured by IIEF-5
Description
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
Time Frame
12 weeks
Title
sexual function measured by IIEF-5
Description
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
Time Frame
6 months
Title
sexual function measured by IIEF-5
Description
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
Time Frame
12 months
Title
sexual function measured by IIEF-5
Description
The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Number of patients with Disease progression
Description
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)
Time Frame
24 months
Title
Bowel function
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Time Frame
4 weeks
Title
Bowel function
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Time Frame
6 weeks
Title
Bowel function
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Time Frame
12 weeks
Title
Bowel function
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Time Frame
6 months
Title
Bowel function
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Time Frame
12 months
Title
Bowel function
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score
Time Frame
24 months
Title
Quality of life measure by EORTC QLQ-C30
Description
measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)
Time Frame
4 weeks
Title
Quality of life measure by EORTC QLQ-C30
Description
measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)
Time Frame
6 weeks
Title
Quality of life measure by EORTC QLQ-C30
Description
measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)
Time Frame
12 weeks
Title
Quality of life measure by EORTC QLQ-C30
Description
measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)
Time Frame
6 months
Title
Quality of life measure by EORTC QLQ-C30
Description
measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)
Time Frame
12 months
Title
Quality of life measure by EORTC QLQ-C30
Description
measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)
Time Frame
24 months
Title
Quality of life measure by EPIC urinary domain bother score
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Time Frame
4 weeks
Title
Quality of life measure by EPIC urinary domain bother score
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Time Frame
6 weeks
Title
Quality of life measure by EPIC urinary domain bother score
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Time Frame
12 weeks
Title
Quality of life measure by EPIC urinary domain bother score
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Time Frame
6 months
Title
Quality of life measure by EPIC urinary domain bother score
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Time Frame
12 months
Title
Quality of life measure by EPIC urinary domain bother score
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score
Time Frame
24 months
Title
Quality of life measure by EPIC sexual domain bother score
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Time Frame
4 weeks
Title
Quality of life measure by EPIC sexual domain bother score
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Time Frame
6 weeks
Title
Quality of life measure by EPIC sexual domain bother score
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Time Frame
12 weeks
Title
Quality of life measure by EPIC sexual domain bother score
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Time Frame
6 months
Title
Quality of life measure by EPIC sexual domain bother score
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Time Frame
12 months
Title
Quality of life measure by EPIC sexual domain bother score
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score
Time Frame
24 months
Title
Quality of life measure by EPIC bowel domain bother score
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Time Frame
4 weeks
Title
Quality of life measure by EPIC bowel domain bother score
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Time Frame
6 weeks
Title
Quality of life measure by EPIC bowel domain bother score
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Time Frame
12 weeks
Title
Quality of life measure by EPIC bowel domain bother score
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Time Frame
6 months
Title
Quality of life measure by EPIC bowel domain bother score
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Time Frame
12 months
Title
Quality of life measure by EPIC bowel domain bother score
Description
measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score
Time Frame
24 months
Title
Quality of life measure by HADS
Description
measured by Hospital Anxiety and Depression Scale (HADS)
Time Frame
4 weeks
Title
Quality of life measure by HADS
Description
measured by Hospital Anxiety and Depression Scale (HADS)
Time Frame
6 weeks
Title
Quality of life measure by HADS
Description
measured by Hospital Anxiety and Depression Scale (HADS)
Time Frame
12 weeks
Title
Quality of life measure by HADS
Description
measured by Hospital Anxiety and Depression Scale (HADS)
Time Frame
6 months
Title
Quality of life measure by HADS
Description
measured by Hospital Anxiety and Depression Scale (HADS)
Time Frame
12 months
Title
Quality of life measure by HADS
Description
measured by Hospital Anxiety and Depression Scale (HADS)
Time Frame
24 months
Title
Rates of primary treatment failure
Description
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
Time Frame
24 months
Title
Rates of adjuvant therapy
Description
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Time Frame
4 weeks
Title
Rates of adjuvant therapy
Description
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Time Frame
6 weeks
Title
Rates of adjuvant therapy
Description
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Time Frame
12 weeks
Title
Rates of adjuvant therapy
Description
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Time Frame
6 months
Title
Rates of adjuvant therapy
Description
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Time Frame
12 months
Title
Rates of adjuvant therapy
Description
defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery
Time Frame
24 months
Title
Perioperative data (operative time)
Description
operative time
Time Frame
1 month
Title
Perioperative data (hemoglobin loss)
Description
hemoglobin loss
Time Frame
1 month
Title
Perioperative data (blood transfusion)
Description
the number of patients need blood transfusion
Time Frame
1 month
Title
Perioperative data (the length of hospital stay)
Description
the length of hospital stay
Time Frame
1 month
Title
Perioperative data(the length of indwelling catheter stay)
Description
the length of indwelling catheter stay
Time Frame
1 month
Title
Pain (measured by a surgical pain scale range from 0 to 10)
Description
measured by a surgical pain scale range from 0 to 10
Time Frame
24 hours
Title
Pain (measured by a surgical pain scale range from 0 to 10)
Description
measured by a surgical pain scale range from 0 to 10
Time Frame
2 weeks
Title
Pain (measured by a surgical pain scale range from 0 to 10)
Description
measured by a surgical pain scale range from 0 to 10
Time Frame
4 weeks
Title
Pain (measured by a surgical pain scale range from 0 to 10)
Description
measured by a surgical pain scale range from 0 to 10
Time Frame
6 weeks
Title
Pain (measured by a surgical pain scale range from 0 to 10)
Description
measured by a surgical pain scale range from 0 to 10
Time Frame
12 weeks
Title
Pain (measured by a surgical pain scale range from 0 to 10)
Description
measured by a surgical pain scale range from 0 to 10
Time Frame
6 months
Title
Adverse effect
Description
identified by the Common Terminology Criteria for Adverse Events (CTCAE)
Time Frame
24 months

10. Eligibility

Sex
Male
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Biming He, MD
Phone
+8615502139410
Email
190589109@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haifeng Wang, MD
Phone
+8613681750891
Email
446720864@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haifeng Wang, MD
Organizational Affiliation
Shanghai East Hospital,Tongji University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai East Hospital, Tongji University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison H-FIRE and Laparoscopic RP in Treating Men With Localized Prostate Cancer

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