Focal ablation treatments for 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
This study is testing if new focal treatments like cryotherapy and high-intensity ultrasound can effectively treat localized prostate cancer in men and improve their urinary and sexual function over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of California, Davis Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT06178354 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of focal ablation techniques, specifically focal cryotherapy and high-intensity focused ultrasound (HIFU), for treating men with localized prostate cancer. The primary objective is to determine the efficacy of these focal therapies, while secondary objectives include assessing patient-reported urinary and sexual function, as well as quality of life over one year. Participants will undergo either cryotherapy or HIFU and will be followed up for safety and efficacy assessments for up to three years.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older with clinically localized grade group 1, 2, or 3 prostate cancer and unilateral MRI-visible lesions.
Not a fit: Patients with nodal or distant metastases, prior prostate cancer treatments, or significant active cardiac disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for men with localized prostate cancer, potentially improving their quality of life.
How similar studies have performed: Other studies have shown promise with focal ablation techniques for localized prostate cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sacramento, California
- University of California Davis Comprehensive Cancer Center — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Marc Dall'Era — University of California, Davis
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.