Clinical trial NCT04978519: Effectiveness of Cryotherapy Study for Prostate Cancer
Official title: Evaluation of the Effectiveness of Cryotherapy for the Treatment of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Focal therapy
Cryotherapy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 16
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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:

  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

Primary outcomes:
measure: Oncological outcome-mpMRI prostate
timeFrame: 6 months
Secondary outcomes:
measure: Oncological Outcomes after cryotherapy
timeFrame: 12 months
measure: Functional outcome after cryotherapy
timeFrame: 6 months and 12 months
measure: Complication after study intervention
timeFrame: 30 days
measure: Oncological outcome-Biopsy
timeFrame: 12 months
measure: Prostate Specific Antigen change
timeFrame: 3 months, 6 months, 9 months, 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital, Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Chi Hang YEE, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.