Clinical trial · Observational
North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS)
- 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)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Cancer of the Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Cancer-specific Quality of Life
- timeFrame
- 4 years
- description
- Prostate Cancer Symptom Indices (PCSI) - measures treatment-related morbidity and adverse effects and is comprised of 4 functional scales measuring Sexual Dysfunction, Bowel Problems, Urinary Incontinence, and Urinary Obstruction/Irritation. Four parallel distress indices measure distress from symptoms. In each index, patient answers are converted to a score from 0 (no symptom/distress) to 100 (maximum symptoms/distress). A 5-10 point difference in QOL is considered "clinically meaningful."
- measure
- Overall Quality of Life
- timeFrame
- 4 years
- description
- Short Form-12 (SF12) - Measures health-related quality of life. Consists of Likert response formats that assess overall health, mental health, vitality, social functioning, and whether ones health or pain limits their daily physical activities. The SF-12 also contains four categorical questions (yes or no) that assess limitations in functioning due to physical and emotional health. The SF-12 provides the Mental Component Summary score (MCS) and Physical Component Summary score (PCS), calculated using norm-based scoring, with the mean set at 50 and standard deviation 10. A lower score indicates lower QOL.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 35 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available