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Prostate CancerNCT04978519

Effectiveness of Cryotherapy Study for Prostate Cancer

A study testing Cryotherapy in people with Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 85 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Cryotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteHong Kong
Study dates
2 Aug 2021to 10 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Prince of Wales Hospital, Chinese University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: 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.

Read the 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

Conditions
Prostate Cancer
Being tested
Cryotherapy
Keywords
Prostate cancer, Focal therapy, Cryotherapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CryotherapyProcedure or surgery

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

Study groups in NCT04978519
Study groupRoleWhat they receive
CryotherapyExperimentalCryotherapy 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.
Receives: Procedure: Cryotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oncological outcome-mpMRI prostate

    Oncological outcome after cryotherapy treatment, as defined by mpMRI prostate

    Measured: 6 months

Secondary outcomes (5)

  1. Oncological Outcomes after cryotherapy

    Oncological outcome after cryotherapy treatment, as defined by mpMRI

    Measured: 12 months

  2. Functional outcome after cryotherapy

    Change in scores in EPIC-26 questionnaires

    Measured: 6 months and 12 months

  3. Complication after study intervention

    Post treatment complication

    Measured: 30 days

  4. Oncological outcome-Biopsy

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

    Measured: 12 months

  5. Prostate Specific Antigen change

    PSA change after treatment

    Measured: 3 months, 6 months, 9 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2021
  2. Study start2 Aug 2021
  3. Primary completion10 Feb 2025
  4. Study completion10 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04978519
Sponsor's protocol ID
CRE 2020.018
Status last verified
Oct 2026
First submitted
22 Jul 2021
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stamey TA, Caldwell M, McNeal JE, Nolley R, Hemenez M, Downs J. The prostate specific antigen era in the United States is over for prostate cancer: what happened in the last 20 years? J Urol. 2004 Oct;172(4 Pt 1):1297-301. doi: 10.1097/01.ju.0000139993.51181.5d.

    PubMed 15371827

  • Klotz L, Vesprini D, Sethukavalan P, Jethava V, Zhang L, Jain S, Yamamoto T, Mamedov A, Loblaw A. Long-term follow-up of a large active surveillance cohort of patients with prostate cancer. J Clin Oncol. 2015 Jan 20;33(3):272-7. doi: 10.1200/JCO.2014.55.1192. Epub 2014 Dec 15.

    PubMed 25512465

  • Kaye DR, Qi J, Morgan TM, Linsell S, Ginsburg KB, Lane BR, Montie JE, Cher ML, Miller DC; Michigan Urological Surgery Improvement Collaborative. Pathological upgrading at radical prostatectomy for patients with Grade Group 1 prostate cancer: implications of confirmatory testing for patients considering active surveillance. BJU Int. 2019 May;123(5):846-853. doi: 10.1111/bju.14554. Epub 2018 Oct 15.

    PubMed 30248225

  • Lindner U, Trachtenberg J, Lawrentschuk N. Focal therapy in prostate cancer: modalities, findings and future considerations. Nat Rev Urol. 2010 Oct;7(10):562-71. doi: 10.1038/nrurol.2010.142. Epub 2010 Sep 14.

    PubMed 20842187

  • Donaldson IA, Alonzi R, Barratt D, Barret E, Berge V, Bott S, Bottomley D, Eggener S, Ehdaie B, Emberton M, Hindley R, Leslie T, Miners A, McCartan N, Moore CM, Pinto P, Polascik TJ, Simmons L, van der Meulen J, Villers A, Willis S, Ahmed HU. Focal therapy: patients, interventions, and outcomes--a report from a consensus meeting. Eur Urol. 2015 Apr;67(4):771-7. doi: 10.1016/j.eururo.2014.09.018. Epub 2014 Oct 1.

    PubMed 25281389

  • Babaian RJ, Donnelly B, Bahn D, Baust JG, Dineen M, Ellis D, Katz A, Pisters L, Rukstalis D, Shinohara K, Thrasher JB. Best practice statement on cryosurgery for the treatment of localized prostate cancer. J Urol. 2008 Nov;180(5):1993-2004. doi: 10.1016/j.juro.2008.07.108. Epub 2008 Sep 25. No abstract available.

    PubMed 18817934

  • Ward JF, Jones JS. Focal cryotherapy for localized prostate cancer: a report from the national Cryo On-Line Database (COLD) Registry. BJU Int. 2012 Jun;109(11):1648-54. doi: 10.1111/j.1464-410X.2011.10578.x. Epub 2011 Oct 28.

    PubMed 22035200

Questions about this trial

What is this clinical trial studying?

A study testing Cryotherapy in people with Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oncological outcome-mpMRI prostate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04978519, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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