Effectiveness of Cryotherapy Study for Prostate Cancer

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Procedure: Cryotherapy

• Registration Number: NCT04978519
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

This is a single-centre prospective, non-randomized trial to investigate the efficacy of cryotherapy in patients with localized prostate cancer.The aim of study is to investigate the safety profile of cryotherapy in the treatment of prostate cancer and to evaluate the oncological control of prostate cancer by means of cryotherapy focal treatment.

Detailed Description

Conventional treatment options for localized prostate cancer include prostatectomy, radiotherapy and active surveillance. However, prostatectomy and radiotherapy carry certain degree of morbidity, including the risks of urinary incontinence, erectile dysfunction and injury to the structures in the proximity. Active surveillance carries the risk of disease progression and psychological distress to the patients. Focal therapy employs the concept of only destroying the significant lesion, resulting in disease cure and improved functional outcome. Among the different options of focal therapy, cryotherapy is one of the most commonly employed energy sources. It exerts its effect through freezing of tissue and vascular injury, leading to destruction of cancer tissue. Our study aims at assess the safety and effectiveness of such treatment in prostate cancer management

Study Timeline

• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-07-22
• Study First Posted: 2021-07-27
• Study Start: 2021-08-02
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-21
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• Men aged between 40 - 85 years

• Visible index lesion(s) on MRI

• Found to have localized prostate cancer after MRI-USG fusion targeted biopsy:

  1. Clinical tumour stage <= T2, or
  2. Gleason score <= 7, or
  3. PSA <= 20 ng/ml

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Exclusion Criteria

• Patients unfit for contrast MRI exam
• Patients with active urinary tract infection
• Patients with bladder pathology including bladder stone and bladder cancer
• Patients with urethral stricture
• Patients with neurogenic bladder and/or sphincter abnormalities
• Patients who fail to give informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cryotherapy	Cryotherapy	Cryotherapy achieves a temperature averaging -40°C. Through the transperineal insertion of treatment probes, it exerts its effect through freezing of tissue and vascular injury, leading to destruction of cancer tissue.

Primary Outcome Measures

Name	Time	Method
Oncological outcome-mpMRI prostate	6 months	Oncological outcome after cryotherapy treatment, as defined by mpMRI prostate

Secondary Outcome Measures

Name	Time	Method
Functional outcome after cryotherapy	6 months and 12 months	Change in scores in EPIC-26 questionnaires
Oncological outcome-Biopsy	12 months	Presence of histologically proven prostate cancer recurrence on biopsy in suspicious cases
Prostate Specific Antigen change	3 months, 6 months, 9 months, 12 months	PSA change after treatment
Oncological Outcomes after cryotherapy	12 months	Oncological outcome after cryotherapy treatment, as defined by mpMRI
Complication after study intervention	30 days	Post treatment complication

Trial Locations

Locations (1)

Prince of Wales Hospital, Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong