Phase II Trial of Focal Cryotherapy for Prostate Cancer

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Device: Focal Cryotherapy

• Registration Number: NCT04138914
• Lead Sponsor: Singapore General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-25
• Primary Completion: 2021-01-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-04
• Study Completion: 2041-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Focal Cryotherapy	Focal Cryotherapy	Focal Cryotherapy using 2 freeze-thaw cycles

Primary Outcome Measures

Name	Time	Method
Mean change in EPIC (Expanded Prostate Composite Index) subdomain score at 1, 3, 6, 12 months compared to baseline	1,3,6 and 12 months
Number of Participants with Treatment-Related Adverse Events assessed by the Clavien-Dindo Scale	at 3 months

Secondary Outcome Measures

Name	Time	Method
Infield (focally treated area) and Outfield (untreated area) positive biopsy rate at 12 months	at 12 months

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore