Prostate Cancer
Conditions
Keywords
Prostate cancer, Focal therapy, Cryotherapy
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
Interventions
PROCEDURECryotherapy
Cryotherapy is administered by using perineal needles, placed under ultrasound guidance to freeze the target tissue.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oncological outcome-mpMRI prostate | 6 months | Oncological outcome after cryotherapy treatment, as defined by mpMRI prostate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication after study intervention | 30 days | Post treatment complication |
| Oncological outcome-Biopsy | 12 months | Presence of histologically proven prostate cancer recurrence on biopsy in suspicious cases |
| Prostate Specific Antigen change | 3 months, 6 months, 9 months, 12 months | PSA change after treatment |
| Oncological Outcomes after cryotherapy | 12 months | Oncological outcome after cryotherapy treatment, as defined by mpMRI |
| Functional outcome after cryotherapy | 6 months and 12 months | Change in scores in EPIC-26 questionnaires |
Countries
Hong Kong
Outcome results
None listed