Clinical trial NCT02564120: North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS)
Official title: North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of Prostate
Cancer of the Prostate
Prostate Cancer
Prostatic Cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-09-30
Enrollment: 1556
Sex: MALE
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly-diagnosed, early stage (localized, non-metastatic) prostate cancer patients

Brief summary: NC ProCESS is a cohort of patients from diverse backgrounds diagnosed with early prostate cancer, who were enrolled from January 2011-June 2013. These patients were recruited throughout North Carolina, and also in partnership with institutions across the country. Patients enrolled before they start treatment, and are then followed prospectively through treatment and then afterwards. This observational study collects information on quality of life, cancer control, and health care received inclusive of treatment and management of subsequent effects including complications and recurrence. The objective of this study is to examine comparative outcomes among different modern prostate cancer treatment options in this cohort of patients.

Detailed description: Localized prostate cancer treatment options is consistently a "highest priority" comparative effectiveness research (CER) topic according to the Institute of Medicine, Agency for Healthcare Research and Quality (AHRQ), and other summary reports. Patients urgently need information on the comparative outcomes of modern treatment options to guide decision-making for this disease that causes significant burden based on its high prevalence, mortality and treatment effects on quality of life. The status quo as it pertains to prostate cancer is significant overtreatment causing potential patient harm, rapid diffusion of new/expensive technologies without proven benefit and patients lacking high quality research evidence to balance direct-to-consumer advertising and guide individualized decision-making.

NC ProCESS is a population-based cohort designed specifically to address well-described knowledge gaps. It was designed in close collaboration with the unique AHRQ consortium stakeholder group, which included representatives from patients, clinicians and policymakers. Stakeholders helped define study design to emphasize "real-world" patients and select patient-centered and relevant outcomes, and have been involved throughout assembly of this patient cohort. The diverse cohort is well-represented by "hard to reach" patients; enrollment before treatment avoids biases with participation and recall. As clinical trials are not feasible to address the central questions in prostate cancer CER, this prospective study will yield the highest level of evidence to inform patients and other stakeholders. With an assembled cohort, this study is necessary to examine comparative outcomes.

Eligibility criteria: Inclusion Criteria:

* Newly-diagnosed, histologically-proven, localized prostate adenocarcinoma.
* Completion of baseline interview prior to initiating therapy.
* Patient ability to complete study interview: no cognitive impairment, language or hearing problems.
* Not diagnosed with prostate cancer through transurethral resection of the prostate (TURP).
* Age 35-80.
* English speaking.
* Has telephone.

Exclusion Criteria:

* Initiation of treatment for prostate cancer prior to completion of baseline interview.
* Cognitive impairment.
* Hearing problems.
* Inability to speak or understand English.

Primary outcomes:
measure: Cancer-specific Quality of Life
timeFrame: 4 years
measure: Overall Quality of Life
timeFrame: 4 years
measure: Prostate Cancer Recurrence
timeFrame: From date of completion of treatment (radiation or surgery) until the date of recurrence or date of death from any cause, whichever came first, assessed up to 5 years.
Secondary outcomes:
measure: Prostate Cancer Anxiety
timeFrame: 4 years
measure: Decisional Regret
timeFrame: 4 years
measure: 5-year Mortality
timeFrame: From date of diagnosis until date of death or end of follow-up up to 5 years
Other outcomes:
measure: Number of Physician Visits During Follow-up
timeFrame: 4 years
measure: Number of Diagnostic Tests and Procedures During Follow-up
timeFrame: 4 years
Locations:
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
References: