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

Not Applicable

Recruiting

• Conditions: Stage II Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Localized Prostate Carcinoma; Stage I Prostate Cancer AJCC v8
• Interventions: Procedure: Cryosurgery; Procedure: High-Intensity Focused Ultrasound Ablation; Other: Survey Administration

• Registration Number: NCT06178354
• Lead Sponsor: Marc Dall'Era, MD

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

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 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.

Study Timeline

• Study Start: 2023-11-09
• Study First Submitted: 2023-12-09
• Study First Submitted QC: 2023-12-09
• Study First Posted: 2023-12-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2028-11
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (cryosurgery, high intensity focused ultrasound)	Survey Administration	Patients undergo focal cryotherapy or high intensity focused ultrasound on study.
Treatment (cryosurgery, high intensity focused ultrasound)	Cryosurgery	Patients undergo focal cryotherapy or high intensity focused ultrasound on study.
Treatment (cryosurgery, high intensity focused ultrasound)	High-Intensity Focused Ultrasound Ablation	Patients undergo focal cryotherapy or high intensity focused ultrasound on study.

Primary Outcome Measures

Name	Time	Method
Pathologic outcome on surveillance prostate biopsy	At year 1 and 3	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.
Proportion of participants who go onto whole gland salvage treatment	At 3 years	Will be estimated using the Kaplan-Meier method.
Salvage whole gland treatment free survival	At 3 years	Will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable Cox proportional hazards models.

Secondary Outcome Measures

Name	Time	Method
Quality of life	At 1 year	Scores from EPIC-26 prostate cancer questionnaire will be used to assess quality of life.
Adverse events	Up to end of treatment visit, approximately 7-14 days after treatment	Number of participants experiencing treatment-related AEs, classified by severity and grade.
Sexual function	At 1 year	Scores from EPIC-26 prostate cancer questionnaire will be used to assess sexual function.
Urinary function	At 1 year	Scores from Expanded Prostate Cancer Index Composite (EPIC-26) prostate cancer questionnaire will be used to assess urinary function.

Trial Locations

Locations (1)

University of California Davis Comprehensive Cancer Center; 🇺🇸 Sacramento, California, United States