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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Localized Prostate Carcinoma; 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 / Treatment: Other: Survey Administration; Procedure: Cryosurgery; Procedure: High-Intensity Focused Ultrasound Ablation

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of California Davis Comprehensive Cancer Center
      • Principal Investigator: Marc Dall'Era
      • Contact: Marc Dall'Era; Phone Number: 916-734-3772; Email: mdallera@ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (cryosurgery, high intensity focused ultrasound); Patients undergo focal cryotherapy or high intensity focused ultrasound on study.

Other: Survey Administration; Ancillary studies; Procedure: Cryosurgery; Undergo focal cryotherapy ablation; Other Names: Cryoablation; cryosurgical ablation; Ablation, Cryo; Procedure: High-Intensity Focused Ultrasound Ablation; Undergo high intensity frequency ultrasound ablation; Other Names: HIFU; Echopulse; High Intensity Focused Ultrasound; Echotherapy; High Intensity Focused Ultrasound Therapy; High-intensity Focused Ultrasound; High-intensity Focused Ultrasound Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Proportion of participants who go onto whole gland salvage treatment	Will be estimated using the Kaplan-Meier method.	At 3 years
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary function	Scores from Expanded Prostate Cancer Index Composite (EPIC-26) prostate cancer questionnaire will be used to assess urinary function.	At 1 year
Sexual function	Scores from EPIC-26 prostate cancer questionnaire will be used to assess sexual function.	At 1 year
Quality of life	Scores from EPIC-26 prostate cancer questionnaire will be used to assess quality of life.	At 1 year
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

Collaborators and Investigators

• Sponsor: Marc Dall'Era, MD
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Marc Dall'Era, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2023
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: December 9, 2023
• First Submitted That Met QC Criteria: December 9, 2023
• First Posted (Estimated): December 21, 2023

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 9, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: UCDCC306 (Other Identifier: University of California Davis Comprehensive Cancer Center); P30CA093373 (U.S. NIH Grant/Contract); NCI-2023-09811 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No