Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06178354

Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer

Led by Marc Dall'Era, MD · Updated on 2024-12-16

100

Participants Needed

1

Research Sites

290 weeks

Total Duration

On this page

Sponsors

M

Marc Dall'Era, MD

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This clinical trial evaluates the effectiveness of focal ablation with either focal cryotherapy or high intensity frequency ultrasound for the treatment of men with localized prostate cancer. Focal cryotherapy kills tumor cells by freezing them. High intensity frequency ultrasound uses highly focused ultrasound waves to produce heat and destroy tumor cells.

CONDITIONS

Official Title

Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and willing to sign informed consent
  • Clinically localized grade group 1, 2, or 3 prostate cancer with unilateral MRI-visible lesion(s) up to 3 lesions
  • Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less (Karnofsky score 70% or higher)
  • Men aged 18 years or older at consent
  • Life expectancy of 5 years or more
  • Willing and able to follow study visit schedule and procedures for the study duration
Not Eligible

You will not qualify if you...

  • Presence of nodal or distant metastases
  • Prior treatment for prostate cancer
  • Planned cancer treatment including radiation, hormonal therapy, or surgery within 6 months before focal therapy
  • Known contraindications to general anesthesia
  • Uncorrectable bleeding disorders
  • Significant active cardiac disease within the last 6 months such as NYHA class 4 congestive heart failure, unstable angina, or recent myocardial infarction
  • Any condition preventing informed consent
  • Any condition that may interfere with safety or compliance during the trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States, 95817

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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