Optimizing the Effectiveness of Routine Post-treatment Surveillance in Prostate Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Cancer of the Prostate; Prostatic Cancer; Cancer of Prostate

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.

• Study Type: Observational
• Enrollment (Actual): 11314

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
National Cancer Data Base; Patients within the National Cancer Database with newly diagnosed prostate cancer between 2004 and 2010. Participating institutions each provided a random of sample of 10 patients to be included in the final cohort.
NC ProCESS; The North Carolina Prostate cancer Comparative Effectiveness & Survivorship Study (NC ProCESS) is a prospective population-based cohort of >1,000 patients with newly diagnosed prostate cancer, enrolled from January 2011 through June 2013.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Time to death or date of last follow-up after primary treatment with surgery or radiation.	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.
Prostate Cancer Anxiety	Prostate cancer anxiety was measured annually (starting 12 months after participant enrollment) using the validated Memorial Anxiety Scale for Prostate Cancer (MAX-PC). The instrument contains 18 questions across 3 subscales assessing anxiety related to prostate cancer (11 items), PSA testing (3 items), and fear of recurrence (4 items). Each item was scored on a Likert-type scale (1 to 4), with a higher score indicating greater anxiety. The subscale means represent the average scores across the items in that sub-scale. The mean Total MAX-PC scores represent the average scores across the 3 subscales (anxiety related to prostate cancer; anxiety related to PSA testing; and anxiety related to prostate cancer recurrence).	12 to 60 months after participant enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Prostate Cancer Recurrence	Time to recurrence represents the period between completion of the first course of treatment (i.e., radiation or surgery) and the date of prostate cancer recurrence (if prostate cancer recurrence occurred).	Completion of primary treatment with surgery or radiation to earliest of prostate cancer recurrence, loss to follow-up, or end of study period
Treatment for Prostate Cancer Recurrence	Receipt of subsequent treatment when prostate cancer has recurred after primary treatment with either surgery or radiation.	Completion of primary treatment with surgery or radiation to earliest of prostate cancer recurrence, loss to follow-up, or end of study period
Prostate Cancer-Specific Health-Related Quality of Life	Prostate cancer-specific health-related quality of life was assessed using the validated and well-published Prostate Cancer Symptom Indices (PCSI). PCSI assesses treatment-related morbidity and includes scales that measure sexual, bowel, and urinary symptoms. Patient responses are converted to a score from 0 (no symptoms) to 100 (maximum symptoms). A higher score indicates greater morbidity and poorer organ system function. PCSI was assessed at baseline, 3 months, 12 months and annually thereafter.	12 to 60 months after participant enrollment
Global Health-Related Quality of Life	Global health-related quality of life was assessed using the validated Short-Form 12 (SF-12). The SF-12 survey consists of Likert response formats and assesses overall health, mental health, vitality, social functioning, and whether one's daily physical activities are limited by their health or pain. The SF-12 also includes four binary response (yes or no) questions that assess limitations in function due to physical and emotional health. The SF-12 provides a Mental Component Score and a Physical Component Score, each calculated using norm-based scoring, with a mean score of 50 and standard deviation of 10. A lower score indicates lower health-related quality of life. SF-12 was assessed at baseline, 3 months, 12 months and annually thereafter.	12 to 60 months after participant enrollment

Collaborators and Investigators

• Sponsor: Alliance Foundation Trials, LLC.
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Ronald Chen, MD, MPH, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: November 3, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (Estimate): November 6, 2016

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: AFT-30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The investigators do not plan to share data or to make individual participant data available.