NCT07207902

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
5mo left

Started Jun 2025

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jun 2025Dec 2026

First Submitted

Initial submission to the registry

April 7, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 6, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

April 7, 2025

Last Update Submit

September 26, 2025

Conditions

Prostate Cancer

Keywords

prostate cancerfocal therapyactive surveillance

Outcome Measures

Primary Outcomes (1)

  • Treatment choice

    Incidence of surveillance, focal therapy, or other treatment choice

    12 months

Secondary Outcomes (1)

  • Decision regret and anxiety scale

    12 months

Study Arms (1)

Men with prostate cancer

OTHER
Behavioral: Explainer video

Interventions

Explainer videoBEHAVIORAL

2 minute explainer video on treatment options

Men with prostate cancer

Eligibility Criteria

Age40 Years - 80 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly men with prostate cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • David S Finley, MD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Urology

Study Record Dates

First Submitted

April 7, 2025

First Posted

October 6, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 6, 2025

Record last verified: 2025-06

Locations

US(1)