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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02957357
• Other study ID #: AFT-30
• Status: Completed
• Start date: February 2016
• Est. completion date: January 31, 2019

Study information

• Verified date: May 2021
• Source: Alliance Foundation Trials, LLC.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11314
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer of Prostate
• Cancer of the Prostate
• Prostate Cancer
• Prostatic Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alliance Foundation Trials, LLC.	Patient-Centered Outcomes Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	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
Secondary	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
Secondary	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