Effectiveness of Cryotherapy Study for Prostate Cancer

January 21, 2024 updated by: Chi Hang Yee, Chinese University of Hong Kong

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Chi Hang YEE, MBBS, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

July 22, 2021

First Submitted That Met QC Criteria

July 22, 2021

First Posted (Actual)

July 27, 2021

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 21, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE 2020.018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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