Evaluation of the Effectiveness of Cryotherapy for the Treatment of Prostate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Chinese University of Hong Kong
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Oncological outcome-mpMRI prostate
- Status
- Completed
- Last Updated
- last year
Overview
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
Investigators
Chi Hang Yee
Honorary Associate Professor
Chinese University of Hong Kong
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
Outcomes
Primary Outcomes
Oncological outcome-mpMRI prostate
Time Frame: 6 months
Oncological outcome after cryotherapy treatment, as defined by mpMRI prostate
Secondary Outcomes
- Functional outcome after cryotherapy(6 months and 12 months)
- Oncological outcome-Biopsy(12 months)
- Prostate Specific Antigen change(3 months, 6 months, 9 months, 12 months)
- Oncological Outcomes after cryotherapy(12 months)
- Complication after study intervention(30 days)