Surveillance or Focal Therapy (SOFT)

Kaiser Permanente

Status: Active, not recruiting

Conditions: Prostate Cancer

Treatments: Behavioral: Explainer video

Study type: Interventional

Funder types: Other

Identifiers

NCT07207902

IRB Tracking Number: 057399

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Men with prostate cancer

Other group

Treatment:

Behavioral: Explainer video