Focal ablation treatments for localized prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of California Davis Comprehensive Cancer Center
  Sacramento, California, United States Recruiting

Study contacts

• Principal investigator: Marc Dall'Era — University of California, Davis
• Study coordinator: Office of Clinical Research
• Email: OCRReferral@health.ucdavis.edu
• Phone: 916-382-6970

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.