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Freezing or heating prostate tumors: a targeted alternative to surgery?

NCT ID NCT06178354

Disease control Sponsor: University of California, Davis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This trial tests whether focal ablation—using extreme cold (cryotherapy) or high-intensity ultrasound (HIFU)—can effectively destroy prostate tumors while leaving healthy tissue unharmed. It enrolls men with early-stage, localized prostate cancer that shows up on MRI. The goal is to control the disease with fewer side effects than whole-gland treatments like surgery or radiation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
focal cryotherapy or high-intensity focused ultrasound
What this could lead to
If successful, this approach could offer a less invasive treatment option for localized prostate cancer, potentially reducing side effects like incontinence and impotence compared to whole-gland treatments.
What could go wrong
This is a phase 2 study with only 100 participants, so results are preliminary. The cancer may not be fully controlled, and some men may still need additional treatment. Risks include infection, bleeding, and urinary or sexual problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • University of California Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

    Contact Email: •••••@•••••

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