Status:
RECRUITING
Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer
Lead Sponsor:
Marc Dall'Era, MD
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Localized Prostate Carcinoma
Stage I Prostate Cancer AJCC v8
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 cr...
Detailed Description
PRIMARY OBJECTIVE: 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06178354
Start Date
November 9 2023
End Date
June 1 2029
Last Update
December 16 2024
Active Locations (1)
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1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817