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Focal Ablation for Localized Prostate Cancer

This study is looking at two ways to treat localized prostate cancer: focal cryotherapy and high-intensity focused ultrasound (HIFU) ablation. Focal cryotherapy uses freezing to kill cancer cells, while HIFU uses focused sound waves to heat and destroy them. The study aims to see how well these treatments work by checking prostate biopsies at 1 and 3 years, and by seeing how many men need more extensive treatment within 3 years. You might be able to join if you are a man aged 18 or older with localized prostate cancer (Stage I, II, or IIIA/B) that can be seen on an MRI. This study is currently unclear on its recruitment status and plans to enroll 100 participants.

Study design
This interventional study plans to enroll 100 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo either focal cryotherapy or high-intensity focused ultrasound ablation. You would then have follow-up appointments at 7-14 days and periodically for up to 3 years.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed up for up to 3 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06178354

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

Recruiting
NAAges 18+InterventionalTreatment
University of California, Davis
~100 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:CryosurgeryHigh-Intensity Focused Ultrasound AblationSurvey Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pathologic outcome on surveillance prostate biopsy
Measured over At year 1 and 3
+2 more outcomes measured

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

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

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

Who to contact

Office of Clinical Research
[email protected]
916-382-6970
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Pathologic outcome on surveillance prostate biopsyAt year 1 and 3

    Confidence intervals for the pathologic response rate will be calculated using the Wilson score method. Pathologic response rate will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable logistic regression.

  • Proportion of participants who go onto whole gland salvage treatmentAt 3 years

    Will be estimated using the Kaplan-Meier method.

  • Salvage whole gland treatment free survivalAt 3 years

    Will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable Cox proportional hazards models.