Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer

Stage IIIB Prostate Cancer AJCC v8 Clinical Trial

Official title:

A Pragmatic Phase 2 Study of Focal Ablation (Focal Cryotherapy or High Intensity Frequency Ultrasound) in Men With Clinically Localized Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06178354
• Other study ID #: UCDCC306
• Secondary ID: NCI-2023-09811UC
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Stage I Prostate Cancer AJCC v8
• Stage II Prostate Cancer AJCC v8
• Stage IIIA Prostate Cancer AJCC v8
• Stage IIIB Prostate Cancer AJCC v8

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