Status:
COMPLETED
Pioneering Advances in Care and Education (PACE)
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
CentraCare Adult & Pediatric Urology
Lancaster Urology
Conditions:
Decision Support Systems, Clinical
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
A critical public health need exists for improved prognostic tools to distinguish aggressive from slow growing prostate cancer at diagnosis, and for better support systems to guide patients in decisio...
Eligibility Criteria
Inclusion
- 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
- Participants will be ineligible if they:
- have pursued any active therapy for prostate cancer will be excluded;
- are unable to read/speak English; or
- if their managing urologist does NOT deem them as a candidate for active surveillance.
Key Trial Info
Start Date :
July 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT03397160
Start Date
July 19 2018
End Date
September 30 2020
Last Update
June 12 2023
Active Locations (4)
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1
Palo Alto Medical Foundation
Palo Alto, California, United States, 94301
2
University of California San Francisco
San Francisco, California, United States, 94158
3
CentraCare Clinic Adult & Pediatric Urology
Sartell, Minnesota, United States, 56377
4
Lancaster Urology
Lancaster, Pennsylvania, United States, 17604-3200