Surveillance or Focal Therapy

NCT ID: NCT07207902

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-12-01

Brief Summary

Patients with newly diagnosed low-intermediate risk prostate cancer often are not advised of all the options in an easy to understand way. This trial will show patients a 2 minute animated Explainer video to better understand their treatment options. Patients will choose their treatment choice (surveillance, focal therapy, or standard treatment option) and we will determine disease related anxiety and decision regret scores.

Detailed Description

Low risk prostate cancer is usually monitored with active surveillance (AS). Some evidence suggests no differences in health-related quality of life (HRQoL) and wellness between men undergoing AS and those receiving treatment. However, other studies have shown a significant subset of patients suffers from anxiety or depression related to disease uncertainty. Many patients are given an "all-or-none" binary choice between monitoring or radical treatment. Focal therapy (FT), however, is a potentially less intense treatment option that exists between these extreme choices but is not always presented to the patient due to provider variability. This study seeks to define the proportion of newly diagnosed low/low-int risk prostate cancer patients who elect to pursue HIFU or surveillance when presented with all treatment options devoid of persuasive rhetoric using an animated explainer video. Secondary outcomes will include anxiety score and decision regret.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Men with prostate cancer

Group Type: OTHER

Explainer video

Intervention Type: BEHAVIORAL

2 minute explainer video on treatment options

Interventions

Explainer video

2 minute explainer video on treatment options

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Gleason 3+3 (GG 1) or 3+4 (GG2)
• ≤4 cores
• T1c-T2
• Prostate < 60cc
• MRI non-focal or PIRADS 3-4 in peripheral gland
• Absence of significant anterior disease

Exclusion Criteria

• Anal stenosis
• Prostatic calfcifations
• Latex allergy
• Gleason grade group 3-5
• Multifocal or anterior disease
• Prostate > 60 cc

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

David S Finley, MD

Associate Professor of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David S Finley, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente

Los Angeles, California, United States

Countries

United States

Other Identifiers

IRB Tracking Number: 057399

Identifier Type: -

Identifier Source: org_study_id