N/A
Completed N=1,556
North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS)
Cancer of Prostate · Cancer of the Prostate · Prostate Cancer · Prostatic Cancer
Source: ClinicalTrials.gov NCT02564120 ↗
Enrolled (actual)
1,556
Serious AEs
—
Results posted
Apr 2020
Primary outcomePrimary: Cancer-specific Quality of Life — 44.7; 42.0; 35.9; 52.1 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cancer-specific Quality of Life |
44.7; 42.0; 35.9; 52.1; 44.9; 44.4 | — |
| PRIMARY Overall Quality of Life |
47.8; 52.1; 51.1; 47.6; 50.4; 47.6 | — |
| PRIMARY Prostate Cancer Recurrence |
6.7; 13.5; 3.6; 7.2 | — |
| SECONDARY Prostate Cancer Anxiety |
1.6; 1.4; 1.6; 1.6; 1.5; 1.5 | — |
| SECONDARY Decisional Regret |
9.2; 1.1; 15.0; 8.3; 9.7; 6.5 | — |
| SECONDARY 5-year Mortality |
9.5; 2.9; 3.3; 11.3; 4.8 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02564120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.