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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06178354
Other study ID # UCDCC306
Secondary ID NCI-2023-09811UC
Status Recruiting
Phase N/A
First received
Last updated
Start date November 9, 2023
Est. completion date June 2029

Study information

Verified date December 2023
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 cryotherapy kills tumor cells by freezing them. High intensity frequency ultrasound uses highly focused ultrasound waves to produce heat and destroy tumor cells.


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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 2029
Est. primary completion date November 2028
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Cryosurgery
Undergo focal cryotherapy ablation
High-Intensity Focused Ultrasound Ablation
Undergo high intensity frequency ultrasound ablation
Other:
Survey Administration
Ancillary studies

Locations

Country Name City State
United States University of California Davis Comprehensive Cancer Center Sacramento California

Sponsors (2)

Lead Sponsor Collaborator
Marc Dall'Era, MD National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pathologic outcome on surveillance prostate biopsy Confidence intervals for the pathologic response rate will be calculated using the Wilson score method. Pathologic response rate will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable logistic regression. At year 1 and 3
Primary Proportion of participants who go onto whole gland salvage treatment Will be estimated using the Kaplan-Meier method. At 3 years
Primary Salvage whole gland treatment free survival Will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable Cox proportional hazards models. At 3 years
Secondary Urinary function Scores from Expanded Prostate Cancer Index Composite (EPIC-26) prostate cancer questionnaire will be used to assess urinary function. At 1 year
Secondary Sexual function Scores from EPIC-26 prostate cancer questionnaire will be used to assess sexual function. At 1 year
Secondary Quality of life Scores from EPIC-26 prostate cancer questionnaire will be used to assess quality of life. At 1 year
Secondary Adverse events Number of participants experiencing treatment-related AEs, classified by severity and grade. Up to end of treatment visit, approximately 7-14 days after treatment
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