NCT06178354Recruiting
Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer
A Pragmatic Phase 2 Study of Focal Ablation (Focal Cryotherapy or High Intensity Frequency Ultrasound) in Men With Clinically Localized Prostate Cancer
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 9 Dec 2023
- Start date
- 9 Nov 2023
- Primary completion date
- Nov 2028
- Lead sponsor
- University of California, Davis
- Diseases
- Prostate cancer
- NCT number
- NCT06178354
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 9 Nov 2023 to the primary completion date, Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- 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
Other
- Nodal or distant metastases
- Known contraindications to general anesthesia
- Uncorrectable coagulopathy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.