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

Description

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

Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8

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Study Overview

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Study Details

Study overview

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.

A Pragmatic Phase 2 Study of Focal Ablation (Focal Cryotherapy or High Intensity Frequency Ultrasound) in Men With Clinically Localized Prostate Cancer

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

Condition
Localized Prostate Carcinoma
Intervention / Treatment

-

Contacts and Locations

Sacramento

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States, 95817

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Ability to understand and willingness to sign an informed consent form
  • * Clinically localized grade group 1, 2, or 3 prostate cancer and unilateral magnetic resonance imaging (MRI) visible lesion(s). Up to 3 lesions will be allowed for focal treatment
  • * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky ≥ 70%)
  • * Patients ≥ 18 years of age at time of consent
  • * Life expectancy ≥ 5 years
  • * Ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study
  • * Nodal or distant metastases
  • * Prior treatment for prostate cancer
  • * Anticipated treatment with any cancer intervention, including radiation, hormonal therapy or surgery ≤ 6 months prior to focal therapy in this study
  • * Known contraindications to general anesthesia
  • * Uncorrectable coagulopathy
  • * Significant active cardiac disease within the previous 6 months including: New York Heart Association (NYHA) class 4 congestive heart failure (CHF), unstable angina, or myocardial infarction
  • * Any condition that would prohibit the understanding or rendering of informed consent
  • * Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Marc Dall'Era, MD,

Marc Dall'Era, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

2029-06