Effectiveness of Cryotherapy Study for Prostate Cancer

NCT ID: NCT04978519

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-02

Study Completion Date

2025-02-10

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

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cryotherapy

Intervention Type PROCEDURE

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

Interventions

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Cryotherapy

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

Intervention Type PROCEDURE

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:

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Chi Hang Yee

Honorary Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chi Hang YEE, MBBS

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type BACKGROUND
PMID: 15371827 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25512465 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30248225 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20842187 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25281389 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18817934 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22035200 (View on PubMed)

Other Identifiers

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CRE 2020.018

Identifier Type: -

Identifier Source: org_study_id

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