Surveillance or Focal Therapy

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT07207902
• Lead Sponsor: Kaiser Permanente

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.

Study Timeline

• Study First Submitted: 2025-04-07
• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study First Posted: 2025-10-06
• Last Update Posted: 2025-10-06
• Primary Completion: 2026-08-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Treatment choice	12 months	Incidence of surveillance, focal therapy, or other treatment choice

Secondary Outcome Measures

Name	Time	Method
Decision regret and anxiety scale	12 months	Anxiety and Decision Regret Score

Trial Locations

Locations (1)

Kaiser Permanente; 🇺🇸 Los Angeles, California, United States