Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07207902

Surveillance or Focal Therapy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente

Los Angeles, California, 90027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Explainer video

Behavioral

2 minute explainer video on treatment options

Primary outcomes

  1. Treatment choice

    Time frame: 12 months

    Incidence of surveillance, focal therapy, or other treatment choice

Secondary outcomes

  1. Decision regret and anxiety scale

    Time frame: 12 months

    Anxiety and Decision Regret Score

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

Surveillance or Focal Therapy (SOFT) for Prostate Cancer

Acronym: SOFT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2025
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.