Clinical trial NCT02957357: Optimizing the Effectiveness of Routine Post-treatment Surveillance in Prostate Cancer Survivors
Official title: Optimizing the Effectiveness of Routine Post-treatment Surveillance in Prostate Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of Prostate
Cancer of the Prostate
Prostate Cancer
Prostatic Cancer
Lead sponsor: Alliance Foundation Trials, LLC.
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2016-11-06
Enrollment: 11314
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 14,000 prostate cancer patients in the National Cancer Data Base (nationwide cancer registry) will be analyzed.

The investigators will analyze data from the National Cancer Data Base (NCDB), a cancer registry which is maintained by the American College of Surgeons Commission on Cancer (CoC). Cancer registry staff review hospital and provider records to collect necessary data for the cancer registry so data are available for analysis for this project. There are \>1400 CoC-hospitals; 10 patients will be sampled at each hospital thus 14,000 patients will be available for analysis.

The NC ProCESS cohort consists of newly-diagnosed, early stage (localized, non-metastatic) prostate cancer patients.

Brief 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.

Detailed description: We 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. We hypothesize that patients with a low risk of recurrence may experience more harm than benefit, while patients with a high risk of recurrence may have improved survival from frequent surveillance.

Specific aims: The specific aims are 1) compare survival, procedures/tests, treatments, and side effects in prostate cancer survivors who are followed with alternative surveillance frequencies; and 2) compare quality-of-life outcomes.

Methods:

Aim 1 will use the National Cancer Database, which includes 70 percent of cancer patients across the United States, and will provide results representative of outcomes of prostate cancer survivors. We will compare the effectiveness of the three most common surveillance frequencies (PSA testing every 3 months vs. 6 months vs. 12 months) stratified by risk of recurrence (low-risk, intermediate-risk, high-risk; as defined by the National Comprehensive Cancer Network (NCCN)) and initial treatment (surgery or radiation). The objective of this aim is to quantify the potential benefits (survival) and harms (procedures/tests, treatments, morbidity consequences) of different PSA surveillance frequencies in the 6 patient groups.

The objective of Aim 2 is to quantify the impact of different surveillance frequencies from the patient's perspective. This aim will use quality-of-life data from the North Carolina Prostate cancer Comparative Effectiveness \& Survivorship Study (NC ProCESS), PI Ronald Chen, a prospective population-based cohort of \>1,000 patients with newly diagnosed prostate cancer, enrolled from January 2011 through June 2013. Comparison groups are the same as Aim 1. PSA frequency will be similarly defined using medical record abstraction.

Patient and stakeholder engagement: Through a five-year process, patients have worked with the PI in all phases of this research, including 1) identifying the highest priority research topic, 2) defining the study population/comparators, and 3) identifying outcomes of highest relevance to patients. Patients and other stakeholders will continue to 4) monitor study conduct and progress and 5) design dissemination activities.

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.

Primary outcomes:
measure: Overall Survival
timeFrame: From completion of primary treatment with surgery or radiation to the earliest occurrence of death, loss to follow-up, or the end of the study period.
measure: Prostate Cancer Anxiety
timeFrame: 12 to 60 months after participant enrollment
Secondary outcomes:
measure: Time to Prostate Cancer Recurrence
timeFrame: Completion of primary treatment with surgery or radiation to earliest of prostate cancer recurrence, loss to follow-up, or end of study period
measure: Treatment for Prostate Cancer Recurrence
timeFrame: Completion of primary treatment with surgery or radiation to earliest of prostate cancer recurrence, loss to follow-up, or end of study period
measure: Prostate Cancer-Specific Health-Related Quality of Life
timeFrame: 12 to 60 months after participant enrollment
measure: Global Health-Related Quality of Life
timeFrame: 12 to 60 months after participant enrollment
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Ronald Chen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: