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

NCT ID: NCT02957357

Last Updated: 2021-10-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 11314 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2019-01-31

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.

Conditions

Cancer of Prostate; Cancer of the Prostate; Prostate Cancer; Prostatic Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patient data part of the NCDB
• Diagnosed with prostate cancer in 2004-2005.
• Treated for prostate cancer with surgery (prostatectomy) or radiation therapy

• 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.

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Alliance Foundation Trials, LLC.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Chen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AFT-30

Identifier Type: -

Identifier Source: org_study_id