Recruiting

Cryotherapy & HIFU

Sponsor:

UCLA

Code:

NCT06178354

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

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cryosurgery

High-Intensity Focused Ultrasound Ablation

Survey Administration

Study Details

Brief summary:

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

Study ID

NCT06178354

Start date

Nov 9, 2023

Status verified date

Jun, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (cryosurgery, high intensity focused ultrasound)

Patients undergo focal cryotherapy or high intensity focused ultrasound on study.

Interventions

Cryosurgery

Undergo focal cryotherapy ablation

High-Intensity Focused Ultrasound Ablation

Undergo high intensity frequency ultrasound ablation

Survey Administration

Ancillary studies

Primary outcome measure

  • Pathologic outcome on surveillance prostate biopsy [ Time Frame: At year 1 and 3 ]
  • Proportion of participants who go onto whole gland salvage treatment [ Time Frame: At 3 years ]
  • Salvage whole gland treatment free survival [ Time Frame: At 3 years ]

Central Contacts and Locations

Central contacts

Office of Clinical Research

916-382-6970OCRReferral@health.ucdavis.edu

Locations

University of California Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Office of Clinical Research

916-382-6970OCRReferral@health.ucdavis.edu

Principal Investigator:

Marc Dall'Era

More Information

Sponsor

University of California, Davis

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-06-30.