Clinical trial · Interventional
Pioneering Advances in Care and Education (PACE)
Development, Validation, and Dissemination of an Integrated Risk Prediction Model and Decision Aid to Discern Aggressive Versus Indolent Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial evaluates the use of novel decision support educational materials and services using health coaches. The study includes men newly diagnosed with low-risk prostate cancer. A 160 men will be recruited. Half of the men will receive a call from a health coach before their initial consultation visit with their urologist to review their treatment concerns and questions. The other half will receive usual care provided by the urologist, such as educational materials and services provided by the urologist.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Decision Support Systems, Clinical | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decision Support Intervention (DSI) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual care
- description
- Participants assigned to the control arm will receive usual care, including whatever information materials are provided to them by their urologist.
- type
- ACTIVE_COMPARATOR
- label
- Decision Support Intervention (DSI)
- description
- Participants assigned to the intervention will receive Decision Support Intervention in the form of a decision aid plus health coaching. The decision aid (delivered by internet and as a Portable Document Format (PDF) document) provides participants with a report on options and outcomes as described in the literature; along with more tailored risk information. The tailored risk information will include their estimated risk of harboring more aggressive prostate cancer based on their clinical/pathologic features (i.e., "My Clinical Risk"). The DSI was developed and piloted at UCSF according to the International Patient Decision Aid Standards (see http://ipdas.ohri.ca/) (IRS# 14-13332), and incorporates tailored risk models developed and validated.
- interventionNames
- Behavioral: Decision Support Intervention (DSI)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Male \>=18 years of age and newly diagnosed prostate cancer (PCa) (within 3-months).
* Documentation of a low-risk PCa diagnosis as evidenced by clinical features of the following criteria:
* PSA test at diagnosis \<=15 ng/ml
* Localized PCa (cT1/T2,N0,M0)
* Biopsy Gleason grade 2-6 OR (or 3+4 AND \<=33% cores are positive for adenocarcinoma)
\*\*\*A minimum of 10 diagnostic cores taken by a systematic directed approach. Sampling may be obtained by target transrectal ultrasound (TRUS) or MRI imaging.
* No treatment yet
* No previous radiation or simultaneous use of androgen deprivation
* Prior use of 5-alpha reductase inhibitor is allowed if they have been stopped for 6 or more months and biopsy performed when patient was not taking the drug
* English language proficient and ability to provide informed consent
* Managing urologist considers them a candidate for active surveillance
* Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study, including the ability to read and speak English.
Exclusion Criteria:
* Participants will be ineligible if they:
1. have pursued any active therapy for prostate cancer will be excluded;
2. are unable to read/speak English; or
3. if their managing urologist does NOT deem them as a candidate for active surveillance.References
Publications (1)
- BACKGROUNDhttps://www.frontiersin.org/articles/10.3389/fruro.2023.1127089/full