Effectiveness of Cryotherapy Study for Prostate Cancer

Study Overview
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Brief Summary
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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
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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

Official Title
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Evaluation of the Effectiveness of Cryotherapy for the Treatment of Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Cryotherapy


Participation Criteria
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Eligibility Criteria
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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: Clinical tumour stage <= T2, or Gleason score <= 7, or PSA <= 20 ng/ml 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryotherapy<br>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. | Procedure: Cryotherapy<br>* Cryotherapy is administered by using perineal needles, placed under ultrasound guidance to freeze the target tissue.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncological outcome-mpMRI prostate | Oncological outcome after cryotherapy treatment, as defined by mpMRI prostate | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Focal therapy, Cryotherapy