RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2023-11-09
Study Completion:2029-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06178354

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to understand and willingness to sign an informed consent form
  2. * 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
  3. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky ≥ 70%)
  4. * Patients ≥ 18 years of age at time of consent
  5. * Life expectancy ≥ 5 years
  6. * Ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study
  1. * Nodal or distant metastases
  2. * Prior treatment for prostate cancer
  3. * Anticipated treatment with any cancer intervention, including radiation, hormonal therapy or surgery ≤ 6 months prior to focal therapy in this study
  4. * Known contraindications to general anesthesia
  5. * Uncorrectable coagulopathy
  6. * 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
  7. * Any condition that would prohibit the understanding or rendering of informed consent
  8. * Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial

Contacts and Locations

Principal Investigator

Marc Dall'Era
PRINCIPAL_INVESTIGATOR
University of California, Davis

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Marc Dall'Era, MD

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-09
Study Completion Date2029-06

Study Record Updates

Study Start Date2023-11-09
Study Completion Date2029-06

Terms related to this study

Additional Relevant MeSH Terms

  • 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