Prostate Cancer, Treatment
Conditions
Keywords
Focal therapy, Radical prostatectomy, high-frequency Irreversible electroporation, prostate cancer
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.
Interventions
PROCEDUREFocal 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
PROCEDURElaparoscopic radical prostatectomy
Laparoscopic radical prostatectomy
Sponsors
Shanghai East Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
No minimum to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| urinary function measured by ICIQ | 4 weeks | The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score |
| urinary function measured by EPIC | 4 weeks | 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 | 4 weeks | The urinary function will be measured by a separate EPIC pad-use item |
| urinary function measured by IPSS | 4 weeks | The urinary function will be measured by IPSS (International Prostate Symptom Score) |
| sexual function measured by EPIC | 4 weeks | The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score |
| sexual function measured by IIEF-5 | 4 weeks | The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life measure by EPIC sexual domain bother score | 4 weeks | measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score |
| Rates of primary treatment failure | 24 months | 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 | 4 weeks | defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery |
| Perioperative data (operative time) | 1 month | operative time |
| Perioperative data (hemoglobin loss) | 1 month | hemoglobin loss |
| Quality of life measure by HADS | 4 weeks | measured by Hospital Anxiety and Depression Scale (HADS) |
| Perioperative data (the length of hospital stay) | 1 month | the length of hospital stay |
| Perioperative data(the length of indwelling catheter stay) | 1 month | the length of indwelling catheter stay |
| Pain (measured by a surgical pain scale range from 0 to 10) | 24 hours | measured by a surgical pain scale range from 0 to 10 |
| Adverse effect | 24 months | identified by the Common Terminology Criteria for Adverse Events (CTCAE) |
| Perioperative data (blood transfusion) | 1 month | the number of patients need blood transfusion |
| Quality of life measure by EPIC bowel domain bother score | 4 weeks | measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score |
| Number of patients with Disease progression | 24 months | 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 | 4 weeks | measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score |
| Quality of life measure by EORTC QLQ-C30 | 4 weeks | 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 | 4 weeks | measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score |
Countries
China
Contacts
Primary ContactBiming He, MD
Backup ContactHaifeng Wang, MD
Outcome results
None listed