Comparison H-FIRE and Laparoscopic RP in Treating Men With Localized Prostate Cancer
NCT ID: NCT04278261
Last Updated: 2022-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
216 participants
INTERVENTIONAL
2022-07-01
2026-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Focal therapy
Using focal therapy(high-frequency Irreversible electroporation) to treat patients with localized Prostate cancer
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
Radical prostatectomy
Using laparoscopic radical prostatectomy to treat patients with localized Prostate cancer
laparoscopic radical prostatectomy
Laparoscopic radical prostatectomy
Interventions
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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
laparoscopic radical prostatectomy
Laparoscopic radical prostatectomy
Eligibility Criteria
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Inclusion Criteria
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
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.
80 Years
MALE
Yes
Sponsors
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Shanghai East Hospital
OTHER
Responsible Party
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Principal Investigators
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Haifeng Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai East Hospital,Tongji University School of Medicine
Locations
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Shanghai East Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Other Identifiers
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HIRE-FR-2019001
Identifier Type: -
Identifier Source: org_study_id
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