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Phase II Trial of Focal Cryotherapy for Prostate Cancer

NCT04138914 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-04-04

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Focal Cryotherapy

Ablation of the cancer focus within the prostate using cryotherapy

Sponsors & Collaborators

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Kae Jack Tay, MBBS · Singapore General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2021-01-31
Completion
2041-03-31
FDA Device
Yes

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04138914 on ClinicalTrials.gov