N/A
N=11,314
Optimizing the Effectiveness of Routine Post-treatment Surveillance in Prostate Cancer Survivors
Cancer of Prostate · Cancer of the Prostate · Prostate Cancer · Prostatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02957357 ↗Enrolled (actual)
11,314
Serious AEs
—
Results posted
Oct 2021
Primary outcome: Primary: Overall Survival — 8.7; 8.8; 8.6; 9.0 years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- Male
- Sponsor
- Alliance Foundation Trials, LLC.
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
8.7; 8.8; 8.6; 9.0; 8.8; 8.9 | — |
| PRIMARY Prostate Cancer Anxiety |
1.56; 1.60; 1.52; 1.35; 1.57; 1.45 | — |
| SECONDARY Time to Prostate Cancer Recurrence |
4.4; 3.2; 4.4; 3.3; 3.5; 2.7 | — |
| SECONDARY Treatment for Prostate Cancer Recurrence |
63.2; 84.4; 74.2; 88.3; 72.8; 94.2 | — |
| SECONDARY Prostate Cancer-Specific Health-Related Quality of Life |
70.7; 64.5; 68.9; 68.4; 63.8; 68.2 | — |
| SECONDARY Global Health-Related Quality of Life |
48.0; 49.2; 49.9; 45.9; 48.2; 48.5 | — |
Summary
Through this study, the investigators seek to identify the benefits (improved survival) and harms (more procedures, more treatment, side effects, and quality-of-life impact) from different surveillance frequencies-every three vs. six vs. 12 months. Using the National Cancer Database and quality-of-life data from a large group of prostate cancer survivors, the investigators aim to compare survival, procedures/tests, treatments, and side effects in prostate cancer survivors who are followed with alternative surveillance frequencies and compare quality-of-life outcomes. The overall goal of the study is to provide high-quality data that will allow development of a personalized, risk-based tailored approach to post-treatment surveillance for prostate cancer.
Eligibility Criteria
Inclusion Criteria for the National Cancer Data Base cohort:
- Patient data part of the NCDB
- Diagnosed with prostate cancer in 2004-2005.
- Treated for prostate cancer with surgery (prostatectomy) or radiation therapy
Inclusion/Exclusion Criteria for the NC ProCESS cohort:
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 (NCT02957357). 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.