Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer
NCT ID: NCT06178354
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-11-09
2029-06-30
Brief Summary
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Detailed Description
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I. To determine the efficacy of focal therapy for treatment of prostate cancer.
SECONDARY OBJECTIVES:
I. Patient reported urinary, sexual function and quality of life (QOL) at 1 year.
II. To assess safety.
OUTLINE:
Patients undergo focal cryotherapy or high intensity focused ultrasound on study.
After completion of study treatment, patients are followed up at 7-14 days and periodically for up to 3 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (cryosurgery, high intensity focused ultrasound)
Patients undergo focal cryotherapy or high intensity focused ultrasound on study.
Cryosurgery
Undergo focal cryotherapy ablation
High-Intensity Focused Ultrasound Ablation
Undergo high intensity frequency ultrasound ablation
Survey Administration
Ancillary studies
Interventions
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Cryosurgery
Undergo focal cryotherapy ablation
High-Intensity Focused Ultrasound Ablation
Undergo high intensity frequency ultrasound ablation
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Marc Dall'Era, MD
OTHER
Responsible Party
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Marc Dall'Era, MD
Principal Investigator
Principal Investigators
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Marc Dall'Era
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Countries
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Facility Contacts
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Marc Dall'Era
Role: primary
Other Identifiers
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NCI-2023-09811
Identifier Type: REGISTRY
Identifier Source: secondary_id
UCDCC306
Identifier Type: OTHER
Identifier Source: secondary_id
UCDCC306
Identifier Type: -
Identifier Source: org_study_id