Effectiveness of Cryotherapy Study for Prostate Cancer

The Chinese University of Hong Kong

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: Cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04978519

CRE 2020.018

Details and patient eligibility

About

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.

Full 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

Enrollment: 16 patients

Sex: Male

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Cryotherapy

Experimental group

Description:

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.

Treatment:

Procedure: Cryotherapy