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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryotherapy | Procedure | Cryotherapy is administered by using perineal needles, placed under ultrasound guidance to freeze the target tissue. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oncological outcome-mpMRI prostate | Oncological outcome after cryotherapy treatment, as defined by mpMRI prostate | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Oncological Outcomes after cryotherapy | Oncological outcome after cryotherapy treatment, as defined by mpMRI | 12 months |
| Functional outcome after cryotherapy | Change in scores in EPIC-26 questionnaires |
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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:
Exclusion Criteria:
Only man will develop prostate cancer
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| Name | Affiliation | Role |
|---|---|---|
| Chi Hang YEE, MBBS | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital, Chinese University of Hong Kong | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15371827 | Background | 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. | |
| 25512465 | 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. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 6 months and 12 months |
| Complication after study intervention | Post treatment complication | 30 days |
| Oncological outcome-Biopsy | Presence of histologically proven prostate cancer recurrence on biopsy in suspicious cases | 12 months |
| Prostate Specific Antigen change | PSA change after treatment | 3 months, 6 months, 9 months, 12 months |
| 30248225 | 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. |
| 20842187 | 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. |
| 25281389 | 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. |
| 18817934 | 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. |
| 22035200 | 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |