Clinical trial NCT04278261: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Treatment
Keywords: Focal therapy
Radical prostatectomy
high-frequency Irreversible electroporation
prostate cancer
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 216
Sex: MALE
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: urinary function measured by ICIQ
timeFrame: 4 weeks
measure: urinary function measured by ICIQ
timeFrame: 6 weeks
measure: urinary function measured by ICIQ
timeFrame: 12 weeks
measure: urinary function measured by ICIQ
timeFrame: 6 months
measure: urinary function measured by ICIQ
timeFrame: 12 months
measure: urinary function measured by ICIQ
timeFrame: 24 months
measure: urinary function measured by EPIC
timeFrame: 4 weeks
measure: urinary function measured by EPIC
timeFrame: 6 weeks
measure: urinary function measured by EPIC
timeFrame: 12 weeks
measure: urinary function measured by EPIC
timeFrame: 6 months
measure: urinary function measured by EPIC
timeFrame: 12 months
measure: urinary function measured by EPIC
timeFrame: 24 months
measure: urinary function measured by separate EPIC pad-use item
timeFrame: 4 weeks
measure: urinary function measured by separate EPIC pad-use item
timeFrame: 6 weeks
measure: urinary function measured by separate EPIC pad-use item
timeFrame: 12 weeks
measure: urinary function measured by separate EPIC pad-use item
timeFrame: 6 months
measure: urinary function measured by separate EPIC pad-use item
timeFrame: 12 months
measure: urinary function measured by separate EPIC pad-use item
timeFrame: 24 months
measure: urinary function measured by IPSS
timeFrame: 4 weeks
measure: urinary function measured by IPSS
timeFrame: 6 weeks
measure: urinary function measured by IPSS
timeFrame: 12 weeks
measure: urinary function measured by IPSS
timeFrame: 6 months
measure: urinary function measured by IPSS
timeFrame: 12 months
measure: urinary function measured by IPSS
timeFrame: 24 months
measure: sexual function measured by EPIC
timeFrame: 4 weeks
measure: sexual function measured by EPIC
timeFrame: 6 weeks
measure: sexual function measured by EPIC
timeFrame: 12 weeks
measure: sexual function measured by EPIC
timeFrame: 6 months
measure: sexual function measured by EPIC
timeFrame: 12 months
measure: sexual function measured by EPIC
timeFrame: 24 months
measure: sexual function measured by IIEF-5
timeFrame: 4 weeks
measure: sexual function measured by IIEF-5
timeFrame: 6 weeks
measure: sexual function measured by IIEF-5
timeFrame: 12 weeks
measure: sexual function measured by IIEF-5
timeFrame: 6 months
measure: sexual function measured by IIEF-5
timeFrame: 12 months
measure: sexual function measured by IIEF-5
timeFrame: 24 months
Secondary outcomes:
measure: Number of patients with Disease progression
timeFrame: 24 months
measure: Bowel function
timeFrame: 4 weeks
measure: Bowel function
timeFrame: 6 weeks
measure: Bowel function
timeFrame: 12 weeks
measure: Bowel function
timeFrame: 6 months
measure: Bowel function
timeFrame: 12 months
measure: Bowel function
timeFrame: 24 months
measure: Quality of life measure by EORTC QLQ-C30
timeFrame: 4 weeks
measure: Quality of life measure by EORTC QLQ-C30
timeFrame: 6 weeks
measure: Quality of life measure by EORTC QLQ-C30
timeFrame: 12 weeks
measure: Quality of life measure by EORTC QLQ-C30
timeFrame: 6 months
measure: Quality of life measure by EORTC QLQ-C30
timeFrame: 12 months
measure: Quality of life measure by EORTC QLQ-C30
timeFrame: 24 months
measure: Quality of life measure by EPIC urinary domain bother score
timeFrame: 4 weeks
measure: Quality of life measure by EPIC urinary domain bother score
timeFrame: 6 weeks
measure: Quality of life measure by EPIC urinary domain bother score
timeFrame: 12 weeks
measure: Quality of life measure by EPIC urinary domain bother score
timeFrame: 6 months
measure: Quality of life measure by EPIC urinary domain bother score
timeFrame: 12 months
measure: Quality of life measure by EPIC urinary domain bother score
timeFrame: 24 months
measure: Quality of life measure by EPIC sexual domain bother score
timeFrame: 4 weeks
measure: Quality of life measure by EPIC sexual domain bother score
timeFrame: 6 weeks
measure: Quality of life measure by EPIC sexual domain bother score
timeFrame: 12 weeks
measure: Quality of life measure by EPIC sexual domain bother score
timeFrame: 6 months
measure: Quality of life measure by EPIC sexual domain bother score
timeFrame: 12 months
measure: Quality of life measure by EPIC sexual domain bother score
timeFrame: 24 months
measure: Quality of life measure by EPIC bowel domain bother score
timeFrame: 4 weeks
measure: Quality of life measure by EPIC bowel domain bother score
timeFrame: 6 weeks
measure: Quality of life measure by EPIC bowel domain bother score
timeFrame: 12 weeks
measure: Quality of life measure by EPIC bowel domain bother score
timeFrame: 6 months
measure: Quality of life measure by EPIC bowel domain bother score
timeFrame: 12 months
measure: Quality of life measure by EPIC bowel domain bother score
timeFrame: 24 months
measure: Quality of life measure by HADS
timeFrame: 4 weeks
measure: Quality of life measure by HADS
timeFrame: 6 weeks
measure: Quality of life measure by HADS
timeFrame: 12 weeks
measure: Quality of life measure by HADS
timeFrame: 6 months
measure: Quality of life measure by HADS
timeFrame: 12 months
measure: Quality of life measure by HADS
timeFrame: 24 months
measure: Rates of primary treatment failure
timeFrame: 24 months
measure: Rates of adjuvant therapy
timeFrame: 4 weeks
measure: Rates of adjuvant therapy
timeFrame: 6 weeks
measure: Rates of adjuvant therapy
timeFrame: 12 weeks
measure: Rates of adjuvant therapy
timeFrame: 6 months
measure: Rates of adjuvant therapy
timeFrame: 12 months
measure: Rates of adjuvant therapy
timeFrame: 24 months
measure: Perioperative data (operative time)
timeFrame: 1 month
measure: Perioperative data (hemoglobin loss)
timeFrame: 1 month
measure: Perioperative data (blood transfusion)
timeFrame: 1 month
measure: Perioperative data (the length of hospital stay)
timeFrame: 1 month
measure: Perioperative data(the length of indwelling catheter stay)
timeFrame: 1 month
measure: Pain (measured by a surgical pain scale range from 0 to 10)
timeFrame: 24 hours
measure: Pain (measured by a surgical pain scale range from 0 to 10)
timeFrame: 2 weeks
measure: Pain (measured by a surgical pain scale range from 0 to 10)
timeFrame: 4 weeks
measure: Pain (measured by a surgical pain scale range from 0 to 10)
timeFrame: 6 weeks
measure: Pain (measured by a surgical pain scale range from 0 to 10)
timeFrame: 12 weeks
measure: Pain (measured by a surgical pain scale range from 0 to 10)
timeFrame: 6 months
measure: Adverse effect
timeFrame: 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital, Tongji University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai East Hospital,Tongji University School of Medicine
name: Haifeng Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: