Effectiveness of Cryotherapy Study for Prostate Cancer

NCT04978519 | Completed

• 1 other identifier: CRE 2020.018
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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 cryotherapy focal treatment.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Focal therapy; Cryotherapy

Outcome Measures

Primary Outcomes (1)

• Oncological outcome-mpMRI prostate

  Oncological outcome after cryotherapy treatment, as defined by mpMRI prostate

  6 months

Secondary Outcomes (5)

• Oncological Outcomes after cryotherapy

  12 months

• Functional outcome after cryotherapy

  6 months and 12 months

• Complication after study intervention

  30 days

• Oncological outcome-Biopsy

  12 months

• Prostate Specific Antigen change

  3 months, 6 months, 9 months, 12 months

Study Arms (1)

Cryotherapy

EXPERIMENTAL

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

Interventions

Cryotherapy PROCEDURE

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

Cryotherapy

Eligibility Criteria

• Age: 40 Years - 85 Years
• Gender Eligibility Details: Only man will develop prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (7)

• 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.

  PMID: 15371827 BACKGROUND

• 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.

  PMID: 25512465 BACKGROUND

• 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.

  PMID: 30248225 BACKGROUND

• 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.

  PMID: 20842187 BACKGROUND

• 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.

  PMID: 25281389 BACKGROUND

• 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.

  PMID: 18817934 BACKGROUND

• 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.

  PMID: 22035200 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Chi Hang YEE, MBBS

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Associate Professor

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: July 27, 2021
• Study Start: August 2, 2021
• Primary Completion: February 10, 2025
• Study Completion: February 10, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)