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Clinical Trials/NCT04138914
NCT04138914
Active, Not Recruiting
N/A

Phase II Trial of Focal Cryotherapy for Prostate Cancer

Singapore General Hospital1 site in 1 country30 target enrollmentMarch 1, 2019
ConditionsProstate Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Singapore General Hospital
Enrollment
30
Locations
1
Primary Endpoint
Mean change in EPIC (Expanded Prostate Composite Index) subdomain score at 1, 3, 6, 12 months compared to baseline
Status
Active, Not Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The current standard of care treatment for prostate cancer confined to the prostate is surgical removal or irradiation of the entire prostate gland. This is effective at curing cancer but result in damage to critical adjacent structures such as the urinary sphincter muscle and erectile nerves resulting in impaired urinary continence and erectile dysfunction. The concept of focal therapy is to treat just the dangerous focus of cancer in the prostate while monitoring the rest of the gland, thus avoiding impairment of urinary continence and erectile function. We aim to evaluate the degree of preservation of continence and erectile function and early oncological outcomes in patients undergoing focal therapy of the prostate using cold energy or cryo- ablation. In this study, we seek to evaluate patient reported outcomes in urinary, sexual, bowel and general health areas at fixed time points after focal cryo-ablation in selected patients with low-volume, localized cancer. The primary goal of this study is to demonstrate whether there is a deterioration of scores in these health areas over 1 year of follow-up. The secondary goal is to measure cancer control at 1 year re-biopsy. Further goals include longer follow-up to monitor cancer progression rates and impact on patient survival.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
March 2041
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Mean change in EPIC (Expanded Prostate Composite Index) subdomain score at 1, 3, 6, 12 months compared to baseline

Time Frame: 1,3,6 and 12 months

Number of Participants with Treatment-Related Adverse Events assessed by the Clavien-Dindo Scale

Time Frame: at 3 months

Secondary Outcomes

  • Infield (focally treated area) and Outfield (untreated area) positive biopsy rate at 12 months(at 12 months)

Study Sites (1)

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