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

Sponsor
Alliance Foundation Trials, LLC. (Other)
Overall Status
Completed
CT.gov ID
NCT02957357
Collaborator
Patient-Centered Outcomes Research Institute (Other)
11,314
36

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    11314 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Optimizing the Effectiveness of Routine Post-treatment Surveillance in Prostate Cancer Survivors
    Study Start Date :
    Feb 1, 2016
    Actual Primary Completion Date :
    Jan 31, 2019
    Actual Study Completion Date :
    Jan 31, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [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.]

      Time to death or date of last follow-up after primary treatment with surgery or radiation.

    2. Prostate Cancer Anxiety [12 to 60 months after participant enrollment]

      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).

    Secondary Outcome Measures

    1. Time to Prostate Cancer Recurrence [Completion of primary treatment with surgery or radiation to earliest of prostate cancer recurrence, loss to follow-up, or end of study period]

      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).

    2. Treatment for Prostate Cancer Recurrence [Completion of primary treatment with surgery or radiation to earliest of prostate cancer recurrence, loss to follow-up, or end of study period]

      Receipt of subsequent treatment when prostate cancer has recurred after primary treatment with either surgery or radiation.

    3. Prostate Cancer-Specific Health-Related Quality of Life [12 to 60 months after participant enrollment]

      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.

    4. Global Health-Related Quality of Life [12 to 60 months after participant enrollment]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Alliance Foundation Trials, LLC.
    • Patient-Centered Outcomes Research Institute

    Investigators

    • Principal Investigator: Ronald Chen, MD, MPH, University of North Carolina, Chapel Hill

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Alliance Foundation Trials, LLC.
    ClinicalTrials.gov Identifier:
    NCT02957357
    Other Study ID Numbers:
    • AFT-30
    First Posted:
    Nov 6, 2016
    Last Update Posted:
    Oct 20, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title National Cancer Data Base NC ProCESS
    Arm/Group Description 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. 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.
    Period Title: Overall Study
    STARTED 10479 835
    COMPLETED 10479 835
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title National Cancer Data Base NC ProCESS Total
    Arm/Group Description 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. 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. Total of all reporting groups
    Overall Participants 10479 835 11314
    Age, Customized (Count of Participants)
    <55
    1329
    12.7%
    115
    13.8%
    1444
    12.8%
    55-64
    4059
    38.7%
    334
    40%
    4393
    38.8%
    65-75
    5091
    48.6%
    345
    41.3%
    5436
    48%
    >75
    0
    0%
    41
    4.9%
    41
    0.4%
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    Male
    10479
    100%
    835
    100%
    11314
    100%
    Race/Ethnicity, Customized (Count of Participants)
    Non-Hispanic White
    7561
    72.2%
    550
    65.9%
    8111
    71.7%
    Non-Hispanic Black
    1375
    13.1%
    248
    29.7%
    1623
    14.3%
    Other
    1543
    14.7%
    37
    4.4%
    1580
    14%
    Region of Enrollment (participants) [Number]
    United States
    10479
    100%
    835
    100%
    11314
    100%

    Outcome Measures

    1. Primary Outcome
    Title Overall Survival
    Description Time to death or date of last follow-up after primary treatment with surgery or radiation.
    Time Frame 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.

    Outcome Measure Data

    Analysis Population Description
    Analysis population comprised patients in the National Cancer Data Base, stratified by risk group (low, intermediate, high) and treatment (radiation or surgery). Survival data on patients in NC ProCESS were not collected for this assessment.
    Arm/Group Title Low Risk/Radiation Low Risk/Surgery Intermediate Risk/Radiation Intermediate Risk/Surgery High Risk/Radiation High Risk/Surgery
    Arm/Group Description Patients with low-risk prostate cancer treated with radiation therapy Patients with low risk prostate cancer treated with radical prostatectomy (i.e. surgery) Patients with intermediate risk prostate cancer treated with radiation therapy Patients with intermediate risk prostate cancer treated with radical prostatectomy (i.e. surgery) Patients with high risk prostate cancer treated with radiation therapy Patients with high risk prostate cancer treated with radical prostatectomy (i.e. surgery)
    Measure Participants 1891 1772 1818 2311 1326 1336
    Participants with <= 1 PSA test in the first year after treatment
    8.7
    8.8
    8.6
    9.0
    8.8
    8.9
    Participants with 2 PSA tests in the first year after treatment
    8.2
    8.4
    8.3
    8.7
    8.6
    8.6
    Participants with >=3 PSA tests in the first year after treatment
    8.2
    8.6
    8.3
    8.9
    8.36
    8.9
    2. Primary Outcome
    Title Prostate Cancer Anxiety
    Description 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).
    Time Frame 12 to 60 months after participant enrollment

    Outcome Measure Data

    Analysis Population Description
    The analysis population comprised participants from the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study who received primary treatment with either radiation therapy or surgery. Data were not collected from the National Cancer Data Base for this assessment.
    Arm/Group Title <= 1 PSA Test in Year 1 After Treatment 2 PSA Tests in Year 1 After Treatment >= 3 PSA Tests in Year 1 After Treatment
    Arm/Group Description Participants in the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study who received primary treatment with radiation therapy or surgery and <=1 PSA tests in the first year after treatment. Participants in the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study who received primary treatment with radiation therapy or surgery and 2 PSA tests in the first year after treatment. Participants in the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study who received primary treatment with radiation therapy or surgery and >=3 PSA tests in the first year after treatment.
    Measure Participants 97 183 309
    Prostate Cancer Anxiety (Subscale 1) at 12 months
    1.56
    (0.70)
    1.60
    (0.74)
    1.52
    (0.62)
    Prostate Cancer Anxiety (Subscale 1) at 24 months
    1.35
    (0.57)
    1.57
    (0.70)
    1.45
    (0.60)
    Prostate Cancer Anxiety (Subscale 1) at 48 months
    1.40
    (0.44)
    1.51
    (0.53)
    1.47
    (0.55)
    Prostate Cancer Anxiety (Subscale 1) at 36 months
    1.40
    (0.57)
    1.51
    (0.64)
    1.46
    (0.63)
    Prostate Cancer Anxiety (Subscale 1) at 60 months
    1.37
    (0.64)
    1.47
    (0.63)
    1.39
    (0.61)
    PSA Test Anxiety (Subscale 2) at 12 months
    1.19
    (0.55)
    1.22
    (0.49)
    1.15
    (0.39)
    PSA Test Anxiety (Subscale 2) at 24 months
    1.10
    (0.32)
    1.23
    (0.53)
    1.13
    (0.39)
    PSA Test Anxiety (Subscale 2) at 36 months
    1.16
    (0.39)
    1.25
    (0.55)
    1.16
    (0.41)
    PSA Test Anxiety (Subscale 2) at 48 months
    1.10
    (0.26)
    1.23
    (0.51)
    1.16
    (0.48)
    PSA Test Anxiety (Subscale 2) at 60 months
    1.11
    (0.30)
    1.19
    (0.48)
    1.11
    (0.34)
    Prostate Cancer Recurrence Anxiety (Subscale 3) at 12 months
    1.70
    (0.68)
    1.82
    (0.69)
    1.71
    (0.60)
    Prostate Cancer Recurrence Anxiety (Subscale 3) at 24 months
    1.68
    (0.63)
    1.78
    (0.61)
    1.70
    (0.66)
    Prostate Cancer Recurrence Anxiety (Subscale 3) at 36 months
    1.60
    (0.63)
    1.85
    (0.73)
    1.68
    (0.63)
    Prostate Cancer Recurrence Anxiety (Subscale 3) at 48 months
    1.64
    (0.58)
    1.73
    (0.62)
    1.75
    (0.71)
    Prostate Cancer Recurrence Anxiety (Subscale 3) at 60 months
    1.70
    (0.70)
    1.77
    (0.59)
    1.69
    (0.65)
    Total MAX-PC (average of subscale means) at 12 months
    1.53
    (0.59)
    1.59
    (0.60)
    1.50
    (0.49)
    Total MAX-PC (average of subscale means) at 24 months
    1.38
    (0.47)
    1.57
    (0.55)
    1.45
    (0.50)
    Total MAX-PC (average of subscale means) at 36 months
    1.43
    (0.51)
    1.57
    (0.56)
    1.44
    (0.49)
    Total MAX-PC (average of subscale means) at 48 months
    1.40
    (0.44)
    1.51
    (0.53)
    1.47
    (0.55)
    Total MAX-PC (average of subscale means) at 60 months
    1.40
    (0.53)
    1.49
    (0.51)
    1.42
    (0.49)
    3. Secondary Outcome
    Title Time to Prostate Cancer Recurrence
    Description 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).
    Time Frame Completion of primary treatment with surgery or radiation to earliest of prostate cancer recurrence, loss to follow-up, or end of study period

    Outcome Measure Data

    Analysis Population Description
    Analysis population comprised patients in the National Cancer Data Base, stratified by risk group (low, intermediate, high) and treatment (radiation or surgery). Prostate cancer recurrence was assessed within each strata by PSA testing frequency. Recurrence data on patients in NC ProCESS were not collected for this assessment.
    Arm/Group Title Low Risk/Radiation Low Risk/Surgery Intermediate Risk/Radiation Intermediate Risk/Surgery High Risk/Radiation High Risk/Surgery
    Arm/Group Description Patients with low-risk prostate cancer treated with radiation therapy Patients with low risk prostate cancer treated with radical prostatectomy (i.e. surgery) Patients with intermediate risk prostate cancer treated with radiation therapy Patients with intermediate risk prostate cancer treated with radical prostatectomy (i.e. surgery) Patients with high risk prostate cancer treated with radiation therapy Patients with high risk prostate cancer treated with radical prostatectomy (i.e. surgery)
    Measure Participants 1807 1713 1760 2238 1273 1292
    <= 1 PSA test
    4.4
    (2.9)
    3.2
    (3.2)
    4.4
    (2.8)
    3.3
    (2.7)
    3.5
    (2.7)
    2.7
    (2.5)
    2 PSA tests
    5.5
    (2.4)
    2.8
    (2.2)
    4.5
    (2.4)
    3.2
    (2.4)
    3.8
    (2.2)
    3.2
    (2.6)
    >= 3 PSA tests
    4.8
    (2.9)
    3.4
    (2.6)
    3.9
    (2.2)
    3.7
    (2.4)
    4.1
    (2.6)
    2.9
    (2.3)
    4. Secondary Outcome
    Title Treatment for Prostate Cancer Recurrence
    Description Receipt of subsequent treatment when prostate cancer has recurred after primary treatment with either surgery or radiation.
    Time Frame Completion of primary treatment with surgery or radiation to earliest of prostate cancer recurrence, loss to follow-up, or end of study period

    Outcome Measure Data

    Analysis Population Description
    Analysis population comprised patients in the National Cancer Data Base with prostate cancer recurrence, stratified by risk group (low, intermediate, high) and treatment (radiation or surgery). Treatment for recurrence was assessed within each strata by PSA testing frequency. Data on patients in NC ProCESS were not collected for this assessment.
    Arm/Group Title Low Risk/Radiation Low Risk/Surgery Intermediate Risk/Radiation Intermediate Risk/Surgery High Risk/Radiation High Risk/Surgery
    Arm/Group Description Patients with low-risk prostate cancer treated with radiation therapy Patients with low risk prostate cancer treated with radical prostatectomy (i.e. surgery) Patients with intermediate risk prostate cancer treated with radiation therapy Patients with intermediate risk prostate cancer treated with radical prostatectomy (i.e. surgery) Patients with high risk prostate cancer treated with radiation therapy Patients with high risk prostate cancer treated with radical prostatectomy (i.e. surgery)
    Measure Participants 98 108 210 380 268 447
    <= 1 PSA test
    63.2
    84.4
    74.2
    88.3
    72.8
    94.2
    2 PSA tests
    71.4
    91.3
    77.6
    94.7
    83.8
    92.6
    >= 3 PSA tests
    68.8
    88.7
    72.8
    89.6
    83.0
    94.9
    5. Secondary Outcome
    Title Prostate Cancer-Specific Health-Related Quality of Life
    Description 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.
    Time Frame 12 to 60 months after participant enrollment

    Outcome Measure Data

    Analysis Population Description
    The analysis population comprised participants from the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study who received primary treatment with either radiation therapy or surgery. Data were not collected from the National Cancer Data Base for this assessment.
    Arm/Group Title <= 1 PSA Test in Year 1 After Treatment 2 PSA Tests in Year 1 After Treatment >= 3 PSA Tests in Year 1 After Treatment
    Arm/Group Description Participants in the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study who received primary treatment with radiation therapy or surgery and <=1 PSA tests in the first year after treatment. Participants in the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study who received primary treatment with radiation therapy or surgery and 2 PSA tests in the first year after treatment. Participants in the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study who received primary treatment with radiation therapy or surgery and >=3 PSA tests in the first year after treatment.
    Measure Participants 97 182 309
    Sexual dysfunction at 12-months
    70.7
    (32.9)
    64.5
    (34.5)
    68.9
    (31.3)
    Sexual dysfunction at 24-months
    68.4
    (31.5)
    63.8
    (35.2)
    68.2
    (32.6)
    Sexual dysfunction at 36-months
    69.4
    (32.7)
    64.8
    (32.9)
    67.5
    (33.9)
    Sexual dysfunction at 48-months
    74.9
    (29.6)
    64.2
    (34.8)
    69.3
    (33.7)
    Sexual dysfunction at 60-months
    75.4
    (26.8)
    69.7
    (32.8)
    66.0
    (35.4)
    Urinary incontinence at 12-months
    25.4
    (26.6)
    22.3
    (26.6)
    29.4
    (27.1)
    Urinary incontinence at 24-months
    22.9
    (26.6)
    22.5
    (24.1)
    29.1
    (26.8)
    Urinary incontinence at 36-months
    24.3
    (25.6)
    23.5
    (24.9)
    27.5
    (27.1)
    Urinary incontinence at 48-months
    21.1
    (23.9)
    25.0
    (25.2)
    29.5
    (26.3)
    Urinary incontinence at 60-months
    24.0
    (23.1)
    26.6
    (27.4)
    29.1
    (26.3)
    Urinary obstruction/irritation at 12-months
    24.9
    (14.2)
    21.8
    (14.0)
    21.8
    (14.1)
    Urinary obstruction/irritation at 24-months
    20.2
    (11.3)
    20.4
    (13.5)
    20.6
    (13.7)
    Urinary obstruction/irritation at 36-months
    21.4
    (11.4)
    20.6
    (12.8)
    19.9
    (13.0)
    Urinary obstruction/irritation at 48-months
    20.0
    (11.1)
    20.4
    (13.3)
    20.8
    (13.2)
    Urinary obstruction/irritation at 60-months
    21.3
    (11.6)
    21.4
    (14.2)
    19.5
    (12.6)
    Bowel dysfunction at 12-months
    8.7
    (12.4)
    7.6
    (9.6)
    6.3
    (9.0)
    Bowel dysfunction at 24-months
    7.6
    (9.3)
    8.0
    (12.4)
    5.7
    (8.2)
    Bowel dysfunction at 36-months
    7.7
    (9.9)
    6.8
    (9.0)
    5.9
    (9.4)
    Bowel dysfunction at 48-months
    6.8
    (7.0)
    6.2
    (8.6)
    5.5
    (8.4)
    Bowel dysfunction at 60-months
    8.5
    (10.9)
    6.8
    (9.3)
    6.1
    (9.0)
    6. Secondary Outcome
    Title Global Health-Related Quality of Life
    Description 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.
    Time Frame 12 to 60 months after participant enrollment

    Outcome Measure Data

    Analysis Population Description
    The analysis population comprised participants from the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study who received primary treatment with either radiation therapy or surgery. Data were not collected from the National Cancer Data Base for this assessment.
    Arm/Group Title <= 1 PSA Test in Year 1 After Treatment 2 PSA Tests in Year 1 After Treatment >= 3 PSA Tests in Year 1 After Treatment
    Arm/Group Description Participants in the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study who received primary treatment with radiation therapy or surgery and <=1 PSA tests in the first year after treatment. Participants in the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study who received primary treatment with radiation therapy or surgery and 2 PSA tests in the first year after treatment. Participants in the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study who received primary treatment with radiation therapy or surgery and >=3 PSA tests in the first year after treatment.
    Measure Participants 97 180 309
    Physical health score at 12-months
    48.0
    (9.7)
    49.2
    (9.1)
    49.9
    (9.7)
    Physical health score at 24-months
    45.9
    (10.5)
    48.2
    (10.2)
    48.5
    (9.8)
    Physical health score at 36-months
    48.2
    (10.4)
    48.0
    (10.7)
    48.7
    (9.4)
    Physical health score at 48-months
    47.9
    (9.1)
    47.6
    (10.0)
    48.0
    (10.5)
    Physical health score at 60-months
    45.8
    (10.5)
    45.5
    (10.9)
    47.5
    (9.9)
    Mental health score at 12-months
    53.9
    (8.0)
    54.1
    (7.4)
    54.7
    (8.1)
    Mental health score at 24-months
    53.2
    (8.3)
    53.2
    (9.4)
    55.1
    (8.4)
    Mental health score at 36-months
    53.6
    (9.5)
    53.8
    (9.1)
    54.7
    (8.5)
    Mental health score at 48-months
    52.4
    (10.3)
    54.2
    (8.5)
    55.2
    (8.6)
    Mental health score at 60-months
    53.6
    (9.5)
    54.7
    (7.8)
    55.3
    (8.1)

    Adverse Events

    Time Frame Adverse Events not monitored/assessed
    Adverse Event Reporting Description All-Cause Mortality, serious, and other adverse events were not monitored/assessed.
    Arm/Group Title National Cancer Data Base NC ProCESS
    Arm/Group Description 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. 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.
    All Cause Mortality
    National Cancer Data Base NC ProCESS
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN)
    Serious Adverse Events
    National Cancer Data Base NC ProCESS
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN)
    Other (Not Including Serious) Adverse Events
    National Cancer Data Base NC ProCESS
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Ronald Chen
    Organization The University of North Carolina at Chapel Hill
    Phone 984-974-0400
    Email ronald_chen@med.unc.edu
    Responsible Party:
    Alliance Foundation Trials, LLC.
    ClinicalTrials.gov Identifier:
    NCT02957357
    Other Study ID Numbers:
    • AFT-30
    First Posted:
    Nov 6, 2016
    Last Update Posted:
    Oct 20, 2021
    Last Verified:
    May 1, 2021