Status:
NOT_YET_RECRUITING
Comparison H-FIRE and Laparoscopic RP in Treating Men With Localized Prostate Cancer
Lead Sponsor:
Shanghai East Hospital
Conditions:
Prostate Cancer
Treatment
Eligibility:
MALE
Up to 80 years
Phase:
NA
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 arm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT04278261
Start Date
July 1 2022
End Date
September 1 2026
Last Update
June 2 2022
Active Locations (1)
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1
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, China, 200120