Trial Outcomes & Findings for Optimizing the Effectiveness of Routine Post-treatment Surveillance in Prostate Cancer Survivors (NCT NCT02957357)
NCT ID: NCT02957357
Last Updated: 2021-10-20
Results Overview
Time to death or date of last follow-up after primary treatment with surgery or radiation.
Recruitment status
COMPLETED
Target enrollment
11314 participants
Primary outcome 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.
Results posted on
2021-10-20
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10479
|
835
|
|
Overall Study
COMPLETED
|
10479
|
835
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimizing the Effectiveness of Routine Post-treatment Surveillance in Prostate Cancer Survivors
Baseline characteristics by cohort
| Measure |
National Cancer Data Base
n=10479 Participants
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
n=835 Participants
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
n=11314 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age group · <55
|
1329 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
1444 Participants
n=5 Participants
|
|
Age, Customized
Age group · 55-64
|
4059 Participants
n=5 Participants
|
334 Participants
n=7 Participants
|
4393 Participants
n=5 Participants
|
|
Age, Customized
Age group · 65-75
|
5091 Participants
n=5 Participants
|
345 Participants
n=7 Participants
|
5436 Participants
n=5 Participants
|
|
Age, Customized
Age group · >75
|
0 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10479 Participants
n=5 Participants
|
835 Participants
n=7 Participants
|
11314 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
7561 Participants
n=5 Participants
|
550 Participants
n=7 Participants
|
8111 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
1375 Participants
n=5 Participants
|
248 Participants
n=7 Participants
|
1623 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1543 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
1580 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10479 participants
n=5 Participants
|
835 participants
n=7 Participants
|
11314 participants
n=5 Participants
|
PRIMARY outcome
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.Population: 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.
Time to death or date of last follow-up after primary treatment with surgery or radiation.
Outcome measures
| Measure |
Low Risk/Radiation
n=1891 Participants
Patients with low-risk prostate cancer treated with radiation therapy
|
Low Risk/Surgery
n=1772 Participants
Patients with low risk prostate cancer treated with radical prostatectomy (i.e. surgery)
|
Intermediate Risk/Radiation
n=1818 Participants
Patients with intermediate risk prostate cancer treated with radiation therapy
|
Intermediate Risk/Surgery
n=2311 Participants
Patients with intermediate risk prostate cancer treated with radical prostatectomy (i.e. surgery)
|
High Risk/Radiation
n=1326 Participants
Patients with high risk prostate cancer treated with radiation therapy
|
High Risk/Surgery
n=1336 Participants
Patients with high risk prostate cancer treated with radical prostatectomy (i.e. surgery)
|
|---|---|---|---|---|---|---|
|
Overall Survival
Participants with <= 1 PSA test in the first year after treatment
|
8.7 years
Interval 2.4 to 12.5
|
8.8 years
Interval 2.2 to 12.3
|
8.6 years
Interval 1.2 to 12.5
|
9.0 years
Interval 2.2 to 12.5
|
8.8 years
Interval 2.4 to 12.4
|
8.9 years
Interval 2.3 to 12.5
|
|
Overall Survival
Participants with >=3 PSA tests in the first year after treatment
|
8.2 years
Interval 2.3 to 12.2
|
8.6 years
Interval 2.1 to 12.3
|
8.3 years
Interval 2.4 to 12.4
|
8.9 years
Interval 2.2 to 12.2
|
8.36 years
Interval 2.2 to 12.2
|
8.9 years
Interval 2.4 to 12.6
|
|
Overall Survival
Participants with 2 PSA tests in the first year after treatment
|
8.2 years
Interval 2.5 to 12.6
|
8.4 years
Interval 2.5 to 12.4
|
8.3 years
Interval 2.3 to 12.74
|
8.7 years
Interval 2.3 to 12.4
|
8.6 years
Interval 0.5 to 12.3
|
8.6 years
Interval 2.2 to 12.4
|
PRIMARY outcome
Timeframe: 12 to 60 months after participant enrollmentPopulation: 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.
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).
Outcome measures
| Measure |
Low Risk/Radiation
n=97 Participants
Patients with low-risk prostate cancer treated with radiation therapy
|
Low Risk/Surgery
n=183 Participants
Patients with low risk prostate cancer treated with radical prostatectomy (i.e. surgery)
|
Intermediate Risk/Radiation
n=309 Participants
Patients with intermediate risk prostate cancer treated with radiation therapy
|
Intermediate Risk/Surgery
Patients with intermediate risk prostate cancer treated with radical prostatectomy (i.e. surgery)
|
High Risk/Radiation
Patients with high risk prostate cancer treated with radiation therapy
|
High Risk/Surgery
Patients with high risk prostate cancer treated with radical prostatectomy (i.e. surgery)
|
|---|---|---|---|---|---|---|
|
Prostate Cancer Anxiety
Prostate Cancer Anxiety (Subscale 1) at 12 months
|
1.56 score on a scale
Standard Deviation 0.70
|
1.60 score on a scale
Standard Deviation 0.74
|
1.52 score on a scale
Standard Deviation 0.62
|
—
|
—
|
—
|
|
Prostate Cancer Anxiety
PSA Test Anxiety (Subscale 2) at 12 months
|
1.19 score on a scale
Standard Deviation 0.55
|
1.22 score on a scale
Standard Deviation 0.49
|
1.15 score on a scale
Standard Deviation 0.39
|
—
|
—
|
—
|
|
Prostate Cancer Anxiety
Prostate Cancer Anxiety (Subscale 1) at 24 months
|
1.35 score on a scale
Standard Deviation 0.57
|
1.57 score on a scale
Standard Deviation 0.70
|
1.45 score on a scale
Standard Deviation 0.60
|
—
|
—
|
—
|
|
Prostate Cancer Anxiety
Prostate Cancer Anxiety (Subscale 1) at 48 months
|
1.40 score on a scale
Standard Deviation 0.44
|
1.51 score on a scale
Standard Deviation 0.53
|
1.47 score on a scale
Standard Deviation 0.55
|
—
|
—
|
—
|
|
Prostate Cancer Anxiety
Prostate Cancer Anxiety (Subscale 1) at 36 months
|
1.40 score on a scale
Standard Deviation 0.57
|
1.51 score on a scale
Standard Deviation 0.64
|
1.46 score on a scale
Standard Deviation 0.63
|
—
|
—
|
—
|
|
Prostate Cancer Anxiety
Prostate Cancer Anxiety (Subscale 1) at 60 months
|
1.37 score on a scale
Standard Deviation 0.64
|
1.47 score on a scale
Standard Deviation 0.63
|
1.39 score on a scale
Standard Deviation 0.61
|
—
|
—
|
—
|
|
Prostate Cancer Anxiety
PSA Test Anxiety (Subscale 2) at 24 months
|
1.10 score on a scale
Standard Deviation 0.32
|
1.23 score on a scale
Standard Deviation 0.53
|
1.13 score on a scale
Standard Deviation 0.39
|
—
|
—
|
—
|
|
Prostate Cancer Anxiety
PSA Test Anxiety (Subscale 2) at 36 months
|
1.16 score on a scale
Standard Deviation 0.39
|
1.25 score on a scale
Standard Deviation 0.55
|
1.16 score on a scale
Standard Deviation 0.41
|
—
|
—
|
—
|
|
Prostate Cancer Anxiety
PSA Test Anxiety (Subscale 2) at 48 months
|
1.10 score on a scale
Standard Deviation 0.26
|
1.23 score on a scale
Standard Deviation 0.51
|
1.16 score on a scale
Standard Deviation 0.48
|
—
|
—
|
—
|
|
Prostate Cancer Anxiety
PSA Test Anxiety (Subscale 2) at 60 months
|
1.11 score on a scale
Standard Deviation 0.30
|
1.19 score on a scale
Standard Deviation 0.48
|
1.11 score on a scale
Standard Deviation 0.34
|
—
|
—
|
—
|
|
Prostate Cancer Anxiety
Prostate Cancer Recurrence Anxiety (Subscale 3) at 12 months
|
1.70 score on a scale
Standard Deviation 0.68
|
1.82 score on a scale
Standard Deviation 0.69
|
1.71 score on a scale
Standard Deviation 0.60
|
—
|
—
|
—
|
|
Prostate Cancer Anxiety
Prostate Cancer Recurrence Anxiety (Subscale 3) at 24 months
|
1.68 score on a scale
Standard Deviation 0.63
|
1.78 score on a scale
Standard Deviation 0.61
|
1.70 score on a scale
Standard Deviation 0.66
|
—
|
—
|
—
|
|
Prostate Cancer Anxiety
Prostate Cancer Recurrence Anxiety (Subscale 3) at 36 months
|
1.60 score on a scale
Standard Deviation 0.63
|
1.85 score on a scale
Standard Deviation 0.73
|
1.68 score on a scale
Standard Deviation 0.63
|
—
|
—
|
—
|
|
Prostate Cancer Anxiety
Prostate Cancer Recurrence Anxiety (Subscale 3) at 48 months
|
1.64 score on a scale
Standard Deviation 0.58
|
1.73 score on a scale
Standard Deviation 0.62
|
1.75 score on a scale
Standard Deviation 0.71
|
—
|
—
|
—
|
|
Prostate Cancer Anxiety
Prostate Cancer Recurrence Anxiety (Subscale 3) at 60 months
|
1.70 score on a scale
Standard Deviation 0.70
|
1.77 score on a scale
Standard Deviation 0.59
|
1.69 score on a scale
Standard Deviation 0.65
|
—
|
—
|
—
|
|
Prostate Cancer Anxiety
Total MAX-PC (average of subscale means) at 12 months
|
1.53 score on a scale
Standard Deviation 0.59
|
1.59 score on a scale
Standard Deviation 0.60
|
1.50 score on a scale
Standard Deviation 0.49
|
—
|
—
|
—
|
|
Prostate Cancer Anxiety
Total MAX-PC (average of subscale means) at 24 months
|
1.38 score on a scale
Standard Deviation 0.47
|
1.57 score on a scale
Standard Deviation 0.55
|
1.45 score on a scale
Standard Deviation 0.50
|
—
|
—
|
—
|
|
Prostate Cancer Anxiety
Total MAX-PC (average of subscale means) at 36 months
|
1.43 score on a scale
Standard Deviation 0.51
|
1.57 score on a scale
Standard Deviation 0.56
|
1.44 score on a scale
Standard Deviation 0.49
|
—
|
—
|
—
|
|
Prostate Cancer Anxiety
Total MAX-PC (average of subscale means) at 48 months
|
1.40 score on a scale
Standard Deviation 0.44
|
1.51 score on a scale
Standard Deviation 0.53
|
1.47 score on a scale
Standard Deviation 0.55
|
—
|
—
|
—
|
|
Prostate Cancer Anxiety
Total MAX-PC (average of subscale means) at 60 months
|
1.40 score on a scale
Standard Deviation 0.53
|
1.49 score on a scale
Standard Deviation 0.51
|
1.42 score on a scale
Standard Deviation 0.49
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Completion of primary treatment with surgery or radiation to earliest of prostate cancer recurrence, loss to follow-up, or end of study periodPopulation: 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.
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).
Outcome measures
| Measure |
Low Risk/Radiation
n=1807 Participants
Patients with low-risk prostate cancer treated with radiation therapy
|
Low Risk/Surgery
n=1713 Participants
Patients with low risk prostate cancer treated with radical prostatectomy (i.e. surgery)
|
Intermediate Risk/Radiation
n=1760 Participants
Patients with intermediate risk prostate cancer treated with radiation therapy
|
Intermediate Risk/Surgery
n=2238 Participants
Patients with intermediate risk prostate cancer treated with radical prostatectomy (i.e. surgery)
|
High Risk/Radiation
n=1273 Participants
Patients with high risk prostate cancer treated with radiation therapy
|
High Risk/Surgery
n=1292 Participants
Patients with high risk prostate cancer treated with radical prostatectomy (i.e. surgery)
|
|---|---|---|---|---|---|---|
|
Time to Prostate Cancer Recurrence
<= 1 PSA test
|
4.4 years
Standard Deviation 2.9
|
3.2 years
Standard Deviation 3.2
|
4.4 years
Standard Deviation 2.8
|
3.3 years
Standard Deviation 2.7
|
3.5 years
Standard Deviation 2.7
|
2.7 years
Standard Deviation 2.5
|
|
Time to Prostate Cancer Recurrence
2 PSA tests
|
5.5 years
Standard Deviation 2.4
|
2.8 years
Standard Deviation 2.2
|
4.5 years
Standard Deviation 2.4
|
3.2 years
Standard Deviation 2.4
|
3.8 years
Standard Deviation 2.2
|
3.2 years
Standard Deviation 2.6
|
|
Time to Prostate Cancer Recurrence
>= 3 PSA tests
|
4.8 years
Standard Deviation 2.9
|
3.4 years
Standard Deviation 2.6
|
3.9 years
Standard Deviation 2.2
|
3.7 years
Standard Deviation 2.4
|
4.1 years
Standard Deviation 2.6
|
2.9 years
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Completion of primary treatment with surgery or radiation to earliest of prostate cancer recurrence, loss to follow-up, or end of study periodPopulation: 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.
Receipt of subsequent treatment when prostate cancer has recurred after primary treatment with either surgery or radiation.
Outcome measures
| Measure |
Low Risk/Radiation
n=98 Participants
Patients with low-risk prostate cancer treated with radiation therapy
|
Low Risk/Surgery
n=108 Participants
Patients with low risk prostate cancer treated with radical prostatectomy (i.e. surgery)
|
Intermediate Risk/Radiation
n=210 Participants
Patients with intermediate risk prostate cancer treated with radiation therapy
|
Intermediate Risk/Surgery
n=380 Participants
Patients with intermediate risk prostate cancer treated with radical prostatectomy (i.e. surgery)
|
High Risk/Radiation
n=268 Participants
Patients with high risk prostate cancer treated with radiation therapy
|
High Risk/Surgery
n=447 Participants
Patients with high risk prostate cancer treated with radical prostatectomy (i.e. surgery)
|
|---|---|---|---|---|---|---|
|
Treatment for Prostate Cancer Recurrence
<= 1 PSA test
|
63.2 percentage of men with recurrence
Interval 46.0 to 78.2
|
84.4 percentage of men with recurrence
Interval 67.2 to 94.7
|
74.2 percentage of men with recurrence
Interval 61.5 to 84.5
|
88.3 percentage of men with recurrence
Interval 80.5 to 93.8
|
72.8 percentage of men with recurrence
Interval 61.8 to 82.1
|
94.2 percentage of men with recurrence
Interval 89.0 to 97.5
|
|
Treatment for Prostate Cancer Recurrence
2 PSA tests
|
71.4 percentage of men with recurrence
Interval 51.3 to 86.8
|
91.3 percentage of men with recurrence
Interval 72.0 to 98.9
|
77.6 percentage of men with recurrence
Interval 65.8 to 86.9
|
94.7 percentage of men with recurrence
Interval 88.1 to 98.3
|
83.8 percentage of men with recurrence
Interval 75.1 to 90.5
|
92.6 percentage of men with recurrence
Interval 85.3 to 97.0
|
|
Treatment for Prostate Cancer Recurrence
>= 3 PSA tests
|
68.8 percentage of men with recurrence
Interval 50.0 to 83.9
|
88.7 percentage of men with recurrence
Interval 77.0 to 95.7
|
72.8 percentage of men with recurrence
Interval 61.8 to 82.1
|
89.6 percentage of men with recurrence
Interval 84.2 to 93.6
|
83.0 percentage of men with recurrence
Interval 73.4 to 90.1
|
94.9 percentage of men with recurrence
Interval 91.0 to 97.4
|
SECONDARY outcome
Timeframe: 12 to 60 months after participant enrollmentPopulation: 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.
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.
Outcome measures
| Measure |
Low Risk/Radiation
n=97 Participants
Patients with low-risk prostate cancer treated with radiation therapy
|
Low Risk/Surgery
n=182 Participants
Patients with low risk prostate cancer treated with radical prostatectomy (i.e. surgery)
|
Intermediate Risk/Radiation
n=309 Participants
Patients with intermediate risk prostate cancer treated with radiation therapy
|
Intermediate Risk/Surgery
Patients with intermediate risk prostate cancer treated with radical prostatectomy (i.e. surgery)
|
High Risk/Radiation
Patients with high risk prostate cancer treated with radiation therapy
|
High Risk/Surgery
Patients with high risk prostate cancer treated with radical prostatectomy (i.e. surgery)
|
|---|---|---|---|---|---|---|
|
Prostate Cancer-Specific Health-Related Quality of Life
Sexual dysfunction at 12-months
|
70.7 score on a scale
Standard Deviation 32.9
|
64.5 score on a scale
Standard Deviation 34.5
|
68.9 score on a scale
Standard Deviation 31.3
|
—
|
—
|
—
|
|
Prostate Cancer-Specific Health-Related Quality of Life
Sexual dysfunction at 24-months
|
68.4 score on a scale
Standard Deviation 31.5
|
63.8 score on a scale
Standard Deviation 35.2
|
68.2 score on a scale
Standard Deviation 32.6
|
—
|
—
|
—
|
|
Prostate Cancer-Specific Health-Related Quality of Life
Sexual dysfunction at 36-months
|
69.4 score on a scale
Standard Deviation 32.7
|
64.8 score on a scale
Standard Deviation 32.9
|
67.5 score on a scale
Standard Deviation 33.9
|
—
|
—
|
—
|
|
Prostate Cancer-Specific Health-Related Quality of Life
Sexual dysfunction at 48-months
|
74.9 score on a scale
Standard Deviation 29.6
|
64.2 score on a scale
Standard Deviation 34.8
|
69.3 score on a scale
Standard Deviation 33.7
|
—
|
—
|
—
|
|
Prostate Cancer-Specific Health-Related Quality of Life
Sexual dysfunction at 60-months
|
75.4 score on a scale
Standard Deviation 26.8
|
69.7 score on a scale
Standard Deviation 32.8
|
66.0 score on a scale
Standard Deviation 35.4
|
—
|
—
|
—
|
|
Prostate Cancer-Specific Health-Related Quality of Life
Urinary incontinence at 12-months
|
25.4 score on a scale
Standard Deviation 26.6
|
22.3 score on a scale
Standard Deviation 26.6
|
29.4 score on a scale
Standard Deviation 27.1
|
—
|
—
|
—
|
|
Prostate Cancer-Specific Health-Related Quality of Life
Urinary incontinence at 24-months
|
22.9 score on a scale
Standard Deviation 26.6
|
22.5 score on a scale
Standard Deviation 24.1
|
29.1 score on a scale
Standard Deviation 26.8
|
—
|
—
|
—
|
|
Prostate Cancer-Specific Health-Related Quality of Life
Urinary incontinence at 36-months
|
24.3 score on a scale
Standard Deviation 25.6
|
23.5 score on a scale
Standard Deviation 24.9
|
27.5 score on a scale
Standard Deviation 27.1
|
—
|
—
|
—
|
|
Prostate Cancer-Specific Health-Related Quality of Life
Urinary incontinence at 48-months
|
21.1 score on a scale
Standard Deviation 23.9
|
25.0 score on a scale
Standard Deviation 25.2
|
29.5 score on a scale
Standard Deviation 26.3
|
—
|
—
|
—
|
|
Prostate Cancer-Specific Health-Related Quality of Life
Urinary incontinence at 60-months
|
24.0 score on a scale
Standard Deviation 23.1
|
26.6 score on a scale
Standard Deviation 27.4
|
29.1 score on a scale
Standard Deviation 26.3
|
—
|
—
|
—
|
|
Prostate Cancer-Specific Health-Related Quality of Life
Urinary obstruction/irritation at 12-months
|
24.9 score on a scale
Standard Deviation 14.2
|
21.8 score on a scale
Standard Deviation 14.0
|
21.8 score on a scale
Standard Deviation 14.1
|
—
|
—
|
—
|
|
Prostate Cancer-Specific Health-Related Quality of Life
Urinary obstruction/irritation at 24-months
|
20.2 score on a scale
Standard Deviation 11.3
|
20.4 score on a scale
Standard Deviation 13.5
|
20.6 score on a scale
Standard Deviation 13.7
|
—
|
—
|
—
|
|
Prostate Cancer-Specific Health-Related Quality of Life
Urinary obstruction/irritation at 36-months
|
21.4 score on a scale
Standard Deviation 11.4
|
20.6 score on a scale
Standard Deviation 12.8
|
19.9 score on a scale
Standard Deviation 13.0
|
—
|
—
|
—
|
|
Prostate Cancer-Specific Health-Related Quality of Life
Urinary obstruction/irritation at 48-months
|
20.0 score on a scale
Standard Deviation 11.1
|
20.4 score on a scale
Standard Deviation 13.3
|
20.8 score on a scale
Standard Deviation 13.2
|
—
|
—
|
—
|
|
Prostate Cancer-Specific Health-Related Quality of Life
Urinary obstruction/irritation at 60-months
|
21.3 score on a scale
Standard Deviation 11.6
|
21.4 score on a scale
Standard Deviation 14.2
|
19.5 score on a scale
Standard Deviation 12.6
|
—
|
—
|
—
|
|
Prostate Cancer-Specific Health-Related Quality of Life
Bowel dysfunction at 12-months
|
8.7 score on a scale
Standard Deviation 12.4
|
7.6 score on a scale
Standard Deviation 9.6
|
6.3 score on a scale
Standard Deviation 9.0
|
—
|
—
|
—
|
|
Prostate Cancer-Specific Health-Related Quality of Life
Bowel dysfunction at 24-months
|
7.6 score on a scale
Standard Deviation 9.3
|
8.0 score on a scale
Standard Deviation 12.4
|
5.7 score on a scale
Standard Deviation 8.2
|
—
|
—
|
—
|
|
Prostate Cancer-Specific Health-Related Quality of Life
Bowel dysfunction at 36-months
|
7.7 score on a scale
Standard Deviation 9.9
|
6.8 score on a scale
Standard Deviation 9.0
|
5.9 score on a scale
Standard Deviation 9.4
|
—
|
—
|
—
|
|
Prostate Cancer-Specific Health-Related Quality of Life
Bowel dysfunction at 48-months
|
6.8 score on a scale
Standard Deviation 7.0
|
6.2 score on a scale
Standard Deviation 8.6
|
5.5 score on a scale
Standard Deviation 8.4
|
—
|
—
|
—
|
|
Prostate Cancer-Specific Health-Related Quality of Life
Bowel dysfunction at 60-months
|
8.5 score on a scale
Standard Deviation 10.9
|
6.8 score on a scale
Standard Deviation 9.3
|
6.1 score on a scale
Standard Deviation 9.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 to 60 months after participant enrollmentPopulation: 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.
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.
Outcome measures
| Measure |
Low Risk/Radiation
n=97 Participants
Patients with low-risk prostate cancer treated with radiation therapy
|
Low Risk/Surgery
n=180 Participants
Patients with low risk prostate cancer treated with radical prostatectomy (i.e. surgery)
|
Intermediate Risk/Radiation
n=309 Participants
Patients with intermediate risk prostate cancer treated with radiation therapy
|
Intermediate Risk/Surgery
Patients with intermediate risk prostate cancer treated with radical prostatectomy (i.e. surgery)
|
High Risk/Radiation
Patients with high risk prostate cancer treated with radiation therapy
|
High Risk/Surgery
Patients with high risk prostate cancer treated with radical prostatectomy (i.e. surgery)
|
|---|---|---|---|---|---|---|
|
Global Health-Related Quality of Life
Physical health score at 12-months
|
48.0 score on a scale
Standard Deviation 9.7
|
49.2 score on a scale
Standard Deviation 9.1
|
49.9 score on a scale
Standard Deviation 9.7
|
—
|
—
|
—
|
|
Global Health-Related Quality of Life
Physical health score at 24-months
|
45.9 score on a scale
Standard Deviation 10.5
|
48.2 score on a scale
Standard Deviation 10.2
|
48.5 score on a scale
Standard Deviation 9.8
|
—
|
—
|
—
|
|
Global Health-Related Quality of Life
Physical health score at 36-months
|
48.2 score on a scale
Standard Deviation 10.4
|
48.0 score on a scale
Standard Deviation 10.7
|
48.7 score on a scale
Standard Deviation 9.4
|
—
|
—
|
—
|
|
Global Health-Related Quality of Life
Physical health score at 48-months
|
47.9 score on a scale
Standard Deviation 9.1
|
47.6 score on a scale
Standard Deviation 10.0
|
48.0 score on a scale
Standard Deviation 10.5
|
—
|
—
|
—
|
|
Global Health-Related Quality of Life
Physical health score at 60-months
|
45.8 score on a scale
Standard Deviation 10.5
|
45.5 score on a scale
Standard Deviation 10.9
|
47.5 score on a scale
Standard Deviation 9.9
|
—
|
—
|
—
|
|
Global Health-Related Quality of Life
Mental health score at 12-months
|
53.9 score on a scale
Standard Deviation 8.0
|
54.1 score on a scale
Standard Deviation 7.4
|
54.7 score on a scale
Standard Deviation 8.1
|
—
|
—
|
—
|
|
Global Health-Related Quality of Life
Mental health score at 24-months
|
53.2 score on a scale
Standard Deviation 8.3
|
53.2 score on a scale
Standard Deviation 9.4
|
55.1 score on a scale
Standard Deviation 8.4
|
—
|
—
|
—
|
|
Global Health-Related Quality of Life
Mental health score at 36-months
|
53.6 score on a scale
Standard Deviation 9.5
|
53.8 score on a scale
Standard Deviation 9.1
|
54.7 score on a scale
Standard Deviation 8.5
|
—
|
—
|
—
|
|
Global Health-Related Quality of Life
Mental health score at 48-months
|
52.4 score on a scale
Standard Deviation 10.3
|
54.2 score on a scale
Standard Deviation 8.5
|
55.2 score on a scale
Standard Deviation 8.6
|
—
|
—
|
—
|
|
Global Health-Related Quality of Life
Mental health score at 60-months
|
53.6 score on a scale
Standard Deviation 9.5
|
54.7 score on a scale
Standard Deviation 7.8
|
55.3 score on a scale
Standard Deviation 8.1
|
—
|
—
|
—
|
Adverse Events
National Cancer Data Base
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NC ProCESS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ronald Chen
The University of North Carolina at Chapel Hill
Phone: 984-974-0400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place