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NCT Number: NCT04278261

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

This trial is comparing the functional and oncological outcomes in treating men with prostate cancer between high-frequency irreversible electroporation and laparoscopic radical prostatectomy.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Treatment Urogenital Diseases Urogenital Neoplasms

Age range

Up to 80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Focal therapy(high-frequency irreversible electroporation)

Procedure

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

Procedure

Laparoscopic radical prostatectomy

Primary outcomes

  1. urinary function measured by ICIQ

    Time frame: 4 weeks

    The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score

  2. urinary function measured by ICIQ

    Time frame: 6 weeks

    The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score

  3. urinary function measured by ICIQ

    Time frame: 12 weeks

    The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score

  4. urinary function measured by ICIQ

    Time frame: 6 months

    The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score

  5. urinary function measured by ICIQ

    Time frame: 12 months

    The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score

  6. urinary function measured by ICIQ

    Time frame: 24 months

    The urinary function will be measured by ICIQ (International Consultation on Incontinence Questionnaire) score

  7. urinary function measured by EPIC

    Time frame: 4 weeks

    The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score

  8. urinary function measured by EPIC

    Time frame: 6 weeks

    The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score

  9. urinary function measured by EPIC

    Time frame: 12 weeks

    The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score

  10. urinary function measured by EPIC

    Time frame: 6 months

    The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score

  11. urinary function measured by EPIC

    Time frame: 12 months

    The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score

  12. urinary function measured by EPIC

    Time frame: 24 months

    The urinary function will be measured by EPIC (Expanded Prostate Cancer Index Composite) urinary domain function score

  13. urinary function measured by separate EPIC pad-use item

    Time frame: 4 weeks

    The urinary function will be measured by a separate EPIC pad-use item

  14. urinary function measured by separate EPIC pad-use item

    Time frame: 6 weeks

    The urinary function will be measured by a separate EPIC pad-use item

  15. urinary function measured by separate EPIC pad-use item

    Time frame: 12 weeks

    The urinary function will be measured by a separate EPIC pad-use item

  16. urinary function measured by separate EPIC pad-use item

    Time frame: 6 months

    The urinary function will be measured by a separate EPIC pad-use item

  17. urinary function measured by separate EPIC pad-use item

    Time frame: 12 months

    The urinary function will be measured by a separate EPIC pad-use item

  18. urinary function measured by separate EPIC pad-use item

    Time frame: 24 months

    The urinary function will be measured by a separate EPIC pad-use item

  19. urinary function measured by IPSS

    Time frame: 4 weeks

    The urinary function will be measured by IPSS (International Prostate Symptom Score)

  20. urinary function measured by IPSS

    Time frame: 6 weeks

    The urinary function will be measured by IPSS (International Prostate Symptom Score)

  21. urinary function measured by IPSS

    Time frame: 12 weeks

    The urinary function will be measured by IPSS (International Prostate Symptom Score)

  22. urinary function measured by IPSS

    Time frame: 6 months

    The urinary function will be measured by IPSS (International Prostate Symptom Score)

  23. urinary function measured by IPSS

    Time frame: 12 months

    The urinary function will be measured by IPSS (International Prostate Symptom Score)

  24. urinary function measured by IPSS

    Time frame: 24 months

    The urinary function will be measured by IPSS (International Prostate Symptom Score)

  25. sexual function measured by EPIC

    Time frame: 4 weeks

    The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score

  26. sexual function measured by EPIC

    Time frame: 6 weeks

    The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score

  27. sexual function measured by EPIC

    Time frame: 12 weeks

    The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score

  28. sexual function measured by EPIC

    Time frame: 6 months

    The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score

  29. sexual function measured by EPIC

    Time frame: 12 months

    The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score

  30. sexual function measured by EPIC

    Time frame: 24 months

    The sexual function will be measured by EPIC (Expanded Prostate Cancer Index Composite) sexual function score

  31. sexual function measured by IIEF-5

    Time frame: 4 weeks

    The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)

  32. sexual function measured by IIEF-5

    Time frame: 6 weeks

    The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)

  33. sexual function measured by IIEF-5

    Time frame: 12 weeks

    The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)

  34. sexual function measured by IIEF-5

    Time frame: 6 months

    The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)

  35. sexual function measured by IIEF-5

    Time frame: 12 months

    The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)

  36. sexual function measured by IIEF-5

    Time frame: 24 months

    The sexual function will be measured by IIEF-5 (5-item version of the International Index of Erectile Function)

Secondary outcomes

  1. Number of patients with Disease progression

    Time frame: 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)

  2. Bowel function

    Time frame: 4 weeks

    measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score

  3. Bowel function

    Time frame: 6 weeks

    measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score

  4. Bowel function

    Time frame: 12 weeks

    measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score

  5. Bowel function

    Time frame: 6 months

    measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score

  6. Bowel function

    Time frame: 12 months

    measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score

  7. Bowel function

    Time frame: 24 months

    measured by EPIC(Expanded Prostate Cancer Index Composite) bowel function score

  8. Quality of life measure by EORTC QLQ-C30

    Time frame: 4 weeks

    measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)

  9. Quality of life measure by EORTC QLQ-C30

    Time frame: 6 weeks

    measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)

  10. Quality of life measure by EORTC QLQ-C30

    Time frame: 12 weeks

    measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)

  11. Quality of life measure by EORTC QLQ-C30

    Time frame: 6 months

    measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)

  12. Quality of life measure by EORTC QLQ-C30

    Time frame: 12 months

    measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)

  13. Quality of life measure by EORTC QLQ-C30

    Time frame: 24 months

    measured by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 module)

  14. Quality of life measure by EPIC urinary domain bother score

    Time frame: 4 weeks

    measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score

  15. Quality of life measure by EPIC urinary domain bother score

    Time frame: 6 weeks

    measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score

  16. Quality of life measure by EPIC urinary domain bother score

    Time frame: 12 weeks

    measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score

  17. Quality of life measure by EPIC urinary domain bother score

    Time frame: 6 months

    measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score

  18. Quality of life measure by EPIC urinary domain bother score

    Time frame: 12 months

    measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score

  19. Quality of life measure by EPIC urinary domain bother score

    Time frame: 24 months

    measured by EPIC(Expanded Prostate Cancer Index Composite) urinary domain bother score

  20. Quality of life measure by EPIC sexual domain bother score

    Time frame: 4 weeks

    measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score

  21. Quality of life measure by EPIC sexual domain bother score

    Time frame: 6 weeks

    measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score

  22. Quality of life measure by EPIC sexual domain bother score

    Time frame: 12 weeks

    measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score

  23. Quality of life measure by EPIC sexual domain bother score

    Time frame: 6 months

    measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score

  24. Quality of life measure by EPIC sexual domain bother score

    Time frame: 12 months

    measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score

  25. Quality of life measure by EPIC sexual domain bother score

    Time frame: 24 months

    measured by EPIC(Expanded Prostate Cancer Index Composite) sexual domain bother score

  26. Quality of life measure by EPIC bowel domain bother score

    Time frame: 4 weeks

    measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score

  27. Quality of life measure by EPIC bowel domain bother score

    Time frame: 6 weeks

    measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score

  28. Quality of life measure by EPIC bowel domain bother score

    Time frame: 12 weeks

    measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score

  29. Quality of life measure by EPIC bowel domain bother score

    Time frame: 6 months

    measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score

  30. Quality of life measure by EPIC bowel domain bother score

    Time frame: 12 months

    measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score

  31. Quality of life measure by EPIC bowel domain bother score

    Time frame: 24 months

    measured by EPIC(Expanded Prostate Cancer Index Composite) bowel domain bother score

  32. Quality of life measure by HADS

    Time frame: 4 weeks

    measured by Hospital Anxiety and Depression Scale (HADS)

  33. Quality of life measure by HADS

    Time frame: 6 weeks

    measured by Hospital Anxiety and Depression Scale (HADS)

  34. Quality of life measure by HADS

    Time frame: 12 weeks

    measured by Hospital Anxiety and Depression Scale (HADS)

  35. Quality of life measure by HADS

    Time frame: 6 months

    measured by Hospital Anxiety and Depression Scale (HADS)

  36. Quality of life measure by HADS

    Time frame: 12 months

    measured by Hospital Anxiety and Depression Scale (HADS)

  37. Quality of life measure by HADS

    Time frame: 24 months

    measured by Hospital Anxiety and Depression Scale (HADS)

  38. Rates of primary treatment failure

    Time frame: 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

  39. Rates of adjuvant therapy

    Time frame: 4 weeks

    defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery

  40. Rates of adjuvant therapy

    Time frame: 6 weeks

    defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery

  41. Rates of adjuvant therapy

    Time frame: 12 weeks

    defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery

  42. Rates of adjuvant therapy

    Time frame: 6 months

    defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery

  43. Rates of adjuvant therapy

    Time frame: 12 months

    defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery

  44. Rates of adjuvant therapy

    Time frame: 24 months

    defined as need the adjuvant therapy including androgen-deprivation therapy, radiotherapy, chemotherapy, and salvage surgery

  45. Perioperative data (operative time)

    Time frame: 1 month

    operative time

  46. Perioperative data (hemoglobin loss)

    Time frame: 1 month

    hemoglobin loss

  47. Perioperative data (blood transfusion)

    Time frame: 1 month

    the number of patients need blood transfusion

  48. Perioperative data (the length of hospital stay)

    Time frame: 1 month

    the length of hospital stay

  49. Perioperative data(the length of indwelling catheter stay)

    Time frame: 1 month

    the length of indwelling catheter stay

  50. Pain (measured by a surgical pain scale range from 0 to 10)

    Time frame: 24 hours

    measured by a surgical pain scale range from 0 to 10

  51. Pain (measured by a surgical pain scale range from 0 to 10)

    Time frame: 2 weeks

    measured by a surgical pain scale range from 0 to 10

  52. Pain (measured by a surgical pain scale range from 0 to 10)

    Time frame: 4 weeks

    measured by a surgical pain scale range from 0 to 10

  53. Pain (measured by a surgical pain scale range from 0 to 10)

    Time frame: 6 weeks

    measured by a surgical pain scale range from 0 to 10

  54. Pain (measured by a surgical pain scale range from 0 to 10)

    Time frame: 12 weeks

    measured by a surgical pain scale range from 0 to 10

  55. Pain (measured by a surgical pain scale range from 0 to 10)

    Time frame: 6 months

    measured by a surgical pain scale range from 0 to 10

  56. Adverse effect

    Time frame: 24 months

    identified by the Common Terminology Criteria for Adverse Events (CTCAE)

Study contacts

Contact information is provided by the study sponsor or research team.

Biming He, MD

CONTACT

[email protected]

+8615502139410

Haifeng Wang, MD

CONTACT

[email protected]

+8613681750891

Sponsors and collaborators

Lead sponsor

Shanghai East Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2020
Registry last updated
Jun 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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