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Eligibility
for males ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

A UCSF PI-initiated study with a primary goal to improve decision quality, anxiety, and uncertainty, thereby increasing appropriate uptake of active surveillance and reducing over-treatment of low-risk prostate cancer. This study involves: completion of questionnaires through the secure website; consultation by a health coach to aid men with prostate cancer in making informed treatment decision (personalized coaching session(s)), bio-specimen collection/analysis.

Official Title

Development, Validation, and Dissemination of an Integrated Risk Prediction Model and Decision Aid to Discern Aggressive vs Indolent Prostate Cancer (Aim 2A)

Details

A UCSF PI-initiated study which includes comprehensive decision support intervention incorporating clinical, lifestyle, tumor genomic, and germline gene variant data.

The web and coaching intervention will: 1) summarize key clinical, lifestyle, and biomarker data elements, 2) communicate relative and absolute risks of upgrading/upstaging based on each of these elements, individually and in aggregate, and 3) provide tailored educational information for informed decision making on treatment options . A key aspect of the intervention will be provision of tiered coaching to the men prior to their physician visits to help them enter information accurately into the system, understand the results of the prediction model, document their questions for their physicians, and prepare them to make better-informed treatment decisions. UCSF research team will develop the decision support intervention in phases, initially using only CAPRA (validated clinical risk score), BMI (body mass index), and smoking data ; and then extend it to include information from genomic and genetic inputs as validation work progresses.

Keywords

Prostate Cancer Tranformative Impact Award Early stage Active Surveillance Decision aid Coaching session Personalized UCSF validation

Eligibility

You can join if…

Open to males ages 18 years and up

are the following:

  1. Men>18 years of age with newly diagnosed (within 3 month) low risk prostatecancer ,who have not yet received cancer-directed therapy, Or Men who are at risk of prostate cancer and coming to have a diagnostic biopsy, and diagnosed with low grade of prostate cancer
  2. Biopsy Gleason score < 3+3,
  3. Has localized (clinical stage < T2N0M0) prostate cancer with a PSA <10ng/ml
  4. Consent to research follow-up

You CAN'T join if...

  1. men with missing data on PSA, stage, Gleason, or extent of biopsy core involvement;no baseline (diagnostic) biopsy or germline DNA sample for research; or no follow-up pathology (from biopsy or RP) after diagnosis.
  2. men unable to consent, prisoners, those with ECOG performance status>2, or psychiatric illness/social situations that would limit compliance with study requirements, or inability to read English or Spanish.

Locations

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02451345
Lead Scientist
Peter Carroll
Study Type
Interventional
Last Updated
December 2015
I'm interested in this study!