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NCT Number: NCT04978519

Effectiveness of Cryotherapy Study for 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.

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Key information

Age range

40 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

cryotherapy

Procedure

Cryotherapy is administered by using perineal needles, placed under ultrasound guidance to freeze the target tissue.

Primary outcomes

  1. Oncological outcome-mpMRI prostate

    Time frame: 6 months

    Oncological outcome after cryotherapy treatment, as defined by mpMRI prostate

Secondary outcomes

  1. Oncological Outcomes after cryotherapy

    Time frame: 12 months

    Oncological outcome after cryotherapy treatment, as defined by mpMRI

  2. Functional outcome after cryotherapy

    Time frame: 6 months and 12 months

    Change in scores in EPIC-26 questionnaires

  3. Complication after study intervention

    Time frame: 30 days

    Post treatment complication

  4. Oncological outcome-Biopsy

    Time frame: 12 months

    Presence of histologically proven prostate cancer recurrence on biopsy in suspicious cases

  5. Prostate Specific Antigen change

    Time frame: 3 months, 6 months, 9 months, 12 months

    PSA change after treatment

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 27, 2021
Registry last updated
Mar 6, 2025

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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