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Effectiveness of Cryotherapy Study for Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Cryotherapy
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Focal therapy, Cryotherapy

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Prince of Wales Hospital, Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cryotherapy

Arm 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.

Outcomes

Primary Outcome Measures

Oncological outcome-mpMRI prostate
Oncological outcome after cryotherapy treatment, as defined by mpMRI prostate

Secondary Outcome Measures

Oncological Outcomes after cryotherapy
Oncological outcome after cryotherapy treatment, as defined by mpMRI
Functional outcome after cryotherapy
Change in scores in EPIC-26 questionnaires
Complication after study intervention
Post treatment complication
Oncological outcome-Biopsy
Presence of histologically proven prostate cancer recurrence on biopsy in suspicious cases
Prostate Specific Antigen change
PSA change after treatment

Full Information

First Posted
July 22, 2021
Last Updated
December 30, 2021
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04978519
Brief Title
Effectiveness of Cryotherapy Study for Prostate Cancer
Official Title
Evaluation of the Effectiveness of Cryotherapy for the Treatment of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, Focal therapy, Cryotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cryotherapy
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Cryotherapy
Intervention Description
Cryotherapy is administered by using perineal needles, placed under ultrasound guidance to freeze the target tissue.
Primary Outcome Measure Information:
Title
Oncological outcome-mpMRI prostate
Description
Oncological outcome after cryotherapy treatment, as defined by mpMRI prostate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Oncological Outcomes after cryotherapy
Description
Oncological outcome after cryotherapy treatment, as defined by mpMRI
Time Frame
12 months
Title
Functional outcome after cryotherapy
Description
Change in scores in EPIC-26 questionnaires
Time Frame
6 months and 12 months
Title
Complication after study intervention
Description
Post treatment complication
Time Frame
30 days
Title
Oncological outcome-Biopsy
Description
Presence of histologically proven prostate cancer recurrence on biopsy in suspicious cases
Time Frame
12 months
Title
Prostate Specific Antigen change
Description
PSA change after treatment
Time Frame
3 months, 6 months, 9 months, 12 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only man will develop prostate cancer
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chi Hang YEE, MBBS
Phone
+852 35052625
Email
yeechihang@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi Hang YEE, MBBS
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital, Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHI HANG YEE, MBBS
Phone
35052625
Email
yeechihang@surgery.cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15371827
Citation
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.
Results Reference
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PubMed Identifier
25512465
Citation
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.
Results Reference
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PubMed Identifier
30248225
Citation
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.
Results Reference
background
PubMed Identifier
20842187
Citation
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.
Results Reference
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PubMed Identifier
25281389
Citation
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.
Results Reference
background
PubMed Identifier
18817934
Citation
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.
Results Reference
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PubMed Identifier
22035200
Citation
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.
Results Reference
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Effectiveness of Cryotherapy Study for Prostate Cancer

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