NCT07207902

Surveillance or Focal Therapy

Surveillance or Focal Therapy (SOFT) for Prostate Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Explainer video	2 minute explainer video on treatment options

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2025-10-06
• Last updated: 2025-10-06

Locations

1 site across 1 country: United States