Trial Outcomes & Findings for North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS) (NCT NCT02564120)
NCT ID: NCT02564120
Last Updated: 2020-04-28
Results Overview
Prostate Cancer Symptom Indices (PCSI) - measures treatment-related morbidity and adverse effects and is comprised of 4 functional scales measuring Sexual Dysfunction, Bowel Problems, Urinary Incontinence, and Urinary Obstruction/Irritation. Four parallel distress indices measure distress from symptoms. In each index, patient answers are converted to a score from 0 (no symptom/distress) to 100 (maximum symptoms/distress). A 5-10 point difference in QOL is considered "clinically meaningful."
COMPLETED
1556 participants
4 years
2020-04-28
Participant Flow
Participant milestones
| Measure |
NC ProCESS Cohort
NC ProCESS is a cohort of patients with early prostate cancer, who were enrolled from January 2011-June 2013. These patients were recruited throughout North Carolina, and also in partnership with institutions across the country. Patients enrolled before they started treatment, and were then followed prospectively.
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|---|---|
|
Overall Study
STARTED
|
1556
|
|
Overall Study
COMPLETED
|
1110
|
|
Overall Study
NOT COMPLETED
|
446
|
Reasons for withdrawal
| Measure |
NC ProCESS Cohort
NC ProCESS is a cohort of patients with early prostate cancer, who were enrolled from January 2011-June 2013. These patients were recruited throughout North Carolina, and also in partnership with institutions across the country. Patients enrolled before they started treatment, and were then followed prospectively.
|
|---|---|
|
Overall Study
Did not return release forms
|
160
|
|
Overall Study
Death
|
58
|
|
Overall Study
Withdrawal by Subject
|
204
|
|
Overall Study
Other medical condition
|
24
|
Baseline Characteristics
North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS)
Baseline characteristics by cohort
| Measure |
Active Surveillance
n=390 Participants
Men placed on active surveillance (i.e., did not receive immediate treatment)
|
SBRT
n=104 Participants
Men who received stereotactic body radiation therapy
|
Radical Prostatectomy
n=547 Participants
Men treated with radical prostatectomy (i.e., surgery)
|
EBRT
n=247 Participants
Men treated with external beam radiation therapy
|
Brachytherapy
n=125 Participants
Men treated with brachytherapy
|
Total
n=1413 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 7.5 • n=93 Participants
|
65.3 years
STANDARD_DEVIATION 6.8 • n=4 Participants
|
61.1 years
STANDARD_DEVIATION 7.0 • n=27 Participants
|
66.8 years
STANDARD_DEVIATION 7.1 • n=483 Participants
|
64.6 years
STANDARD_DEVIATION 7.3 • n=36 Participants
|
64.2 years
STANDARD_DEVIATION 7.2 • n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
390 Participants
n=93 Participants
|
104 Participants
n=4 Participants
|
547 Participants
n=27 Participants
|
247 Participants
n=483 Participants
|
125 Participants
n=36 Participants
|
1413 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
287 Participants
n=93 Participants
|
97 Participants
n=4 Participants
|
382 Participants
n=27 Participants
|
153 Participants
n=483 Participants
|
90 Participants
n=36 Participants
|
1009 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
African American
|
97 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
143 Participants
n=27 Participants
|
83 Participants
n=483 Participants
|
33 Participants
n=36 Participants
|
359 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
45 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
390 participants
n=93 Participants
|
104 participants
n=4 Participants
|
547 participants
n=27 Participants
|
247 participants
n=483 Participants
|
125 participants
n=36 Participants
|
1413 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info \& either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy.
Prostate Cancer Symptom Indices (PCSI) - measures treatment-related morbidity and adverse effects and is comprised of 4 functional scales measuring Sexual Dysfunction, Bowel Problems, Urinary Incontinence, and Urinary Obstruction/Irritation. Four parallel distress indices measure distress from symptoms. In each index, patient answers are converted to a score from 0 (no symptom/distress) to 100 (maximum symptoms/distress). A 5-10 point difference in QOL is considered "clinically meaningful."
Outcome measures
| Measure |
Active Surveillance
n=390 Participants
Patients placed on active surveillance following diagnosis of prostate cancer. Active surveillance was defined with medical records stating this as the plan.
|
Stereotactic Body Radiation Therapy
n=104 Participants
Patients who received initial treatment with stereotactic body radiation therapy (SBRT).
|
Radical Prostatectomy
n=547 Participants
Patients who received initial treatment with radical prostatectomy.
|
External Body Radiation Therapy
n=247 Participants
Patients who received initial treatment with external body radiation therapy (EBRT).
|
Brachytherapy
n=125 Participants
Patients who received initial treatment with brachytherapy.
|
|---|---|---|---|---|---|
|
Cancer-specific Quality of Life
Urinary Obstruction & Irritation - 3-months
|
23.2 score on a scale
Interval 21.7 to 24.7
|
24.3 score on a scale
Interval 21.7 to 26.9
|
27.0 score on a scale
Interval 25.5 to 28.5
|
35.6 score on a scale
Interval 33.0 to 38.2
|
40.3 score on a scale
Interval 36.3 to 44.3
|
|
Cancer-specific Quality of Life
Sexual Dysfunction - Baseline
|
44.7 score on a scale
Interval 40.9 to 48.5
|
42.0 score on a scale
Interval 34.7 to 49.3
|
35.9 score on a scale
Interval 32.8 to 39.0
|
52.1 score on a scale
Interval 47.2 to 57.0
|
44.9 score on a scale
Interval 38.0 to 51.8
|
|
Cancer-specific Quality of Life
Sexual Dysfunction - 3-months
|
44.4 score on a scale
Interval 40.0 to 48.8
|
42.1 score on a scale
Interval 34.7 to 49.5
|
78.0 score on a scale
Interval 75.5 to 80.5
|
65.2 score on a scale
Interval 60.3 to 70.1
|
59.0 score on a scale
Interval 52.3 to 65.7
|
|
Cancer-specific Quality of Life
Sexual Dysfunction - 12-months
|
48.2 score on a scale
Interval 43.8 to 52.6
|
48.2 score on a scale
Interval 40.7 to 55.7
|
70.8 score on a scale
Interval 67.9 to 73.7
|
62.8 score on a scale
Interval 57.8 to 67.8
|
59.3 score on a scale
Interval 52.3 to 66.3
|
|
Cancer-specific Quality of Life
Sexual Dysfunction - 24-months
|
55.2 score on a scale
Interval 50.4 to 60.0
|
48.8 score on a scale
Interval 40.8 to 56.8
|
68.2 score on a scale
Interval 65.0 to 71.4
|
64.9 score on a scale
Interval 59.7 to 70.1
|
62.3 score on a scale
Interval 54.7 to 69.9
|
|
Cancer-specific Quality of Life
Sexual Dysfunction - 36-months
|
50.9 score on a scale
Interval 45.8 to 56.0
|
52.3 score on a scale
Interval 43.7 to 60.9
|
68.6 score on a scale
Interval 65.1 to 72.1
|
64.2 score on a scale
Interval 58.5 to 69.9
|
63.7 score on a scale
Interval 55.9 to 71.5
|
|
Cancer-specific Quality of Life
Sexual Dysfunction - 48-months
|
56.5 score on a scale
Interval 51.1 to 61.9
|
53.9 score on a scale
Interval 44.0 to 63.8
|
69.7 score on a scale
Interval 66.0 to 73.4
|
66.1 score on a scale
Interval 60.4 to 71.8
|
64.0 score on a scale
Interval 55.7 to 72.3
|
|
Cancer-specific Quality of Life
Urinary Obstruction & Irritation - Baseline
|
23.4 score on a scale
Interval 22.0 to 24.8
|
22.9 score on a scale
Interval 20.4 to 25.4
|
23.3 score on a scale
Interval 22.1 to 24.5
|
24.2 score on a scale
Interval 22.2 to 26.2
|
17.5 score on a scale
Interval 15.7 to 19.3
|
|
Cancer-specific Quality of Life
Urinary Obstruction & Irritation - 12-months
|
25.9 score on a scale
Interval 24.1 to 27.7
|
29.5 score on a scale
Interval 26.2 to 32.8
|
21.4 score on a scale
Interval 20.1 to 22.7
|
25.3 score on a scale
Interval 23.2 to 27.4
|
27.6 score on a scale
Interval 24.3 to 30.9
|
|
Cancer-specific Quality of Life
Urinary Obstruction & Irritation - 24-months
|
25.1 score on a scale
Interval 23.3 to 26.9
|
26.4 score on a scale
Interval 23.3 to 29.5
|
19.4 score on a scale
Interval 18.1 to 20.7
|
23.7 score on a scale
Interval 21.6 to 25.8
|
26.9 score on a scale
Interval 23.5 to 30.3
|
|
Cancer-specific Quality of Life
Urinary Obstruction & Irritation - 36-months
|
23.7 score on a scale
Interval 21.9 to 25.5
|
22.8 score on a scale
Interval 19.6 to 26.0
|
19.5 score on a scale
Interval 18.2 to 20.8
|
22.5 score on a scale
Interval 20.3 to 24.7
|
19.5 score on a scale
Interval 16.7 to 22.3
|
|
Cancer-specific Quality of Life
Urinary Obstruction & Irritation - 48-months
|
24.3 score on a scale
Interval 22.3 to 26.3
|
22.9 score on a scale
Interval 19.9 to 25.9
|
19.2 score on a scale
Interval 17.9 to 20.5
|
23.8 score on a scale
Interval 21.5 to 26.1
|
22.2 score on a scale
Interval 19.0 to 25.4
|
|
Cancer-specific Quality of Life
Urinary Incontinence - Baseline
|
11.0 score on a scale
Interval 8.9 to 13.1
|
8.3 score on a scale
Interval 5.2 to 11.4
|
8.6 score on a scale
Interval 7.1 to 10.1
|
14.1 score on a scale
Interval 11.2 to 17.0
|
6.0 score on a scale
Interval 3.4 to 8.6
|
|
Cancer-specific Quality of Life
Urinary Incontinence - 3-months
|
12.3 score on a scale
Interval 9.9 to 14.7
|
12.7 score on a scale
Interval 9.1 to 16.3
|
44.0 score on a scale
Interval 41.3 to 46.7
|
17.6 score on a scale
Interval 14.2 to 21.0
|
15.1 score on a scale
Interval 11.0 to 19.2
|
|
Cancer-specific Quality of Life
Urinary Incontinence - 12-months
|
14.0 score on a scale
Interval 11.4 to 16.6
|
15.2 score on a scale
Interval 10.9 to 19.5
|
31.5 score on a scale
Interval 29.0 to 34.0
|
18.7 score on a scale
Interval 15.0 to 22.4
|
13.9 score on a scale
Interval 9.9 to 17.9
|
|
Cancer-specific Quality of Life
Urinary Incontinence -24-months
|
18.6 score on a scale
Interval 15.4 to 21.8
|
14.8 score on a scale
Interval 10.0 to 19.6
|
29.7 score on a scale
Interval 27.1 to 32.3
|
20.1 score on a scale
Interval 16.3 to 23.9
|
16.3 score on a scale
Interval 11.4 to 21.2
|
|
Cancer-specific Quality of Life
Urinary Incontinence - 36-months
|
15.9 score on a scale
Interval 12.8 to 19.0
|
15.1 score on a scale
Interval 10.5 to 19.7
|
28.8 score on a scale
Interval 26.0 to 31.6
|
20.4 score on a scale
Interval 16.2 to 24.6
|
21.6 score on a scale
Interval 15.7 to 27.5
|
|
Cancer-specific Quality of Life
Urinary Incontinence - 48-months
|
19.9 score on a scale
Interval 16.5 to 23.3
|
11.5 score on a scale
Interval 6.8 to 16.2
|
30.8 score on a scale
Interval 28.0 to 33.6
|
19.9 score on a scale
Interval 15.6 to 24.2
|
16.5 score on a scale
Interval 11.4 to 21.6
|
|
Cancer-specific Quality of Life
Bowel Problems - Baseline
|
6.1 score on a scale
Interval 5.3 to 6.9
|
5.5 score on a scale
Interval 4.2 to 6.8
|
5.8 score on a scale
Interval 5.1 to 6.5
|
7.5 score on a scale
Interval 6.2 to 8.8
|
4.8 score on a scale
Interval 3.5 to 6.1
|
|
Cancer-specific Quality of Life
Bowel Problems - 3-months
|
7.1 score on a scale
Interval 6.0 to 8.2
|
5.6 score on a scale
Interval 4.3 to 6.9
|
7.1 score on a scale
Interval 6.3 to 7.9
|
12.6 score on a scale
Interval 10.5 to 14.7
|
9.0 score on a scale
Interval 7.1 to 10.9
|
|
Cancer-specific Quality of Life
Bowel Problems - 12-months
|
7.1 score on a scale
Interval 5.9 to 8.3
|
5.9 score on a scale
Interval 4.4 to 7.4
|
6.2 score on a scale
Interval 5.4 to 7.0
|
9.4 score on a scale
Interval 7.7 to 11.1
|
7.2 score on a scale
Interval 5.6 to 8.8
|
|
Cancer-specific Quality of Life
Bowel Problems - 24-months
|
6.2 score on a scale
Interval 5.3 to 7.1
|
5.0 score on a scale
Interval 3.8 to 6.2
|
5.6 score on a scale
Interval 4.8 to 6.4
|
9.5 score on a scale
Interval 7.5 to 11.5
|
6.1 score on a scale
Interval 4.6 to 7.6
|
|
Cancer-specific Quality of Life
Bowel Problems - 36-months
|
6.9 score on a scale
Interval 5.8 to 8.0
|
5.9 score on a scale
Interval 4.6 to 7.2
|
5.6 score on a scale
Interval 4.7 to 6.5
|
8.4 score on a scale
Interval 6.5 to 10.3
|
5.8 score on a scale
Interval 3.8 to 7.8
|
|
Cancer-specific Quality of Life
Bowel Problems - 48-months
|
7.1 score on a scale
Interval 5.7 to 8.5
|
4.4 score on a scale
Interval 2.7 to 6.1
|
5.3 score on a scale
Interval 4.4 to 6.2
|
7.1 score on a scale
Interval 5.6 to 8.6
|
7.4 score on a scale
Interval 5.2 to 9.6
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info \& either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy.
Short Form-12 (SF12) - Measures health-related quality of life. Consists of Likert response formats that assess overall health, mental health, vitality, social functioning, and whether ones health or pain limits their daily physical activities. The SF-12 also contains four categorical questions (yes or no) that assess limitations in functioning due to physical and emotional health. The SF-12 provides the Mental Component Summary score (MCS) and Physical Component Summary score (PCS), calculated using norm-based scoring, with the mean set at 50 and standard deviation 10. A lower score indicates lower QOL.
Outcome measures
| Measure |
Active Surveillance
n=390 Participants
Patients placed on active surveillance following diagnosis of prostate cancer. Active surveillance was defined with medical records stating this as the plan.
|
Stereotactic Body Radiation Therapy
n=104 Participants
Patients who received initial treatment with stereotactic body radiation therapy (SBRT).
|
Radical Prostatectomy
n=547 Participants
Patients who received initial treatment with radical prostatectomy.
|
External Body Radiation Therapy
n=247 Participants
Patients who received initial treatment with external body radiation therapy (EBRT).
|
Brachytherapy
n=125 Participants
Patients who received initial treatment with brachytherapy.
|
|---|---|---|---|---|---|
|
Overall Quality of Life
Physical Health - Baseline
|
47.8 score on a scale
Interval 46.7 to 48.9
|
52.1 score on a scale
Interval 50.5 to 53.7
|
51.1 score on a scale
Interval 50.3 to 51.9
|
47.6 score on a scale
Interval 46.2 to 49.0
|
50.4 score on a scale
Interval 48.8 to 52.0
|
|
Overall Quality of Life
Physical Health - 3-months
|
47.6 score on a scale
Interval 46.4 to 48.8
|
50.8 score on a scale
Interval 49.0 to 52.6
|
49.4 score on a scale
Interval 48.5 to 50.3
|
46.4 score on a scale
Interval 45.0 to 47.8
|
49.0 score on a scale
Interval 47.4 to 50.6
|
|
Overall Quality of Life
Physical Health - 12-months
|
48.2 score on a scale
Interval 47.1 to 49.3
|
50.8 score on a scale
Interval 49.2 to 52.4
|
49.8 score on a scale
Interval 48.9 to 50.7
|
46.9 score on a scale
Interval 45.5 to 48.3
|
48.7 score on a scale
Interval 46.8 to 50.6
|
|
Overall Quality of Life
Physical Health - 24-months
|
46.8 score on a scale
Interval 45.5 to 48.1
|
51.2 score on a scale
Interval 49.3 to 53.1
|
48.6 score on a scale
Interval 47.6 to 49.6
|
46.2 score on a scale
Interval 44.7 to 47.7
|
47.3 score on a scale
Interval 45.1 to 49.5
|
|
Overall Quality of Life
Physical Health - 36-months
|
46.8 score on a scale
Interval 45.4 to 48.2
|
50.8 score on a scale
Interval 48.8 to 52.8
|
49.0 score on a scale
Interval 48.0 to 50.0
|
46.6 score on a scale
Interval 44.8 to 48.4
|
48.0 score on a scale
Interval 45.7 to 50.3
|
|
Overall Quality of Life
Physical Health - 48-months
|
46.1 score on a scale
Interval 44.7 to 47.5
|
50.7 score on a scale
Interval 48.5 to 52.9
|
48.4 score on a scale
Interval 47.3 to 49.5
|
45.9 score on a scale
Interval 44.2 to 47.6
|
45.8 score on a scale
Interval 43.3 to 48.3
|
|
Overall Quality of Life
Mental Health - Baseline
|
54.6 score on a scale
Interval 53.8 to 55.4
|
53.2 score on a scale
Interval 51.7 to 54.7
|
52.0 score on a scale
Interval 51.2 to 52.8
|
52.9 score on a scale
Interval 51.7 to 54.1
|
54.8 score on a scale
Interval 53.3 to 56.3
|
|
Overall Quality of Life
Mental Health - 3-months
|
55.0 score on a scale
Interval 54.1 to 55.9
|
54.8 score on a scale
Interval 53.4 to 56.2
|
52.6 score on a scale
Interval 51.7 to 53.5
|
52.9 score on a scale
Interval 51.7 to 54.1
|
53.4 score on a scale
Interval 51.8 to 55.0
|
|
Overall Quality of Life
Mental Health - 12-months
|
54.2 score on a scale
Interval 53.2 to 55.2
|
55.2 score on a scale
Interval 53.9 to 56.5
|
54.1 score on a scale
Interval 53.3 to 54.9
|
54.0 score on a scale
Interval 52.8 to 55.2
|
55.6 score on a scale
Interval 54.1 to 57.1
|
|
Overall Quality of Life
Mental Health - 24-months
|
55.6 score on a scale
Interval 54.6 to 56.6
|
54.7 score on a scale
Interval 53.1 to 56.3
|
54.1 score on a scale
Interval 53.2 to 55.0
|
54.1 score on a scale
Interval 52.8 to 55.4
|
55.8 score on a scale
Interval 54.2 to 57.4
|
|
Overall Quality of Life
Mental Health - 36-months
|
55.3 score on a scale
Interval 54.2 to 56.4
|
54.5 score on a scale
Interval 52.5 to 56.5
|
53.9 score on a scale
Interval 53.0 to 54.8
|
54.2 score on a scale
Interval 52.7 to 55.7
|
55.4 score on a scale
Interval 53.5 to 57.3
|
|
Overall Quality of Life
Mental Health - 48-months
|
54.9 score on a scale
Interval 53.8 to 56.0
|
55.1 score on a scale
Interval 53.1 to 57.1
|
54.5 score on a scale
Interval 53.5 to 55.5
|
54.0 score on a scale
Interval 52.5 to 55.5
|
56.2 score on a scale
Interval 54.2 to 58.2
|
PRIMARY outcome
Timeframe: From date of completion of treatment (radiation or surgery) until the date of recurrence or date of death from any cause, whichever came first, assessed up to 5 years.Population: We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info \& either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy.
Percentage of patients who had a recurrence of prostate cancer during 5 years of follow-up.
Outcome measures
| Measure |
Active Surveillance
n=104 Participants
Patients placed on active surveillance following diagnosis of prostate cancer. Active surveillance was defined with medical records stating this as the plan.
|
Stereotactic Body Radiation Therapy
n=547 Participants
Patients who received initial treatment with stereotactic body radiation therapy (SBRT).
|
Radical Prostatectomy
n=247 Participants
Patients who received initial treatment with radical prostatectomy.
|
External Body Radiation Therapy
n=125 Participants
Patients who received initial treatment with external body radiation therapy (EBRT).
|
Brachytherapy
Patients who received initial treatment with brachytherapy.
|
|---|---|---|---|---|---|
|
Prostate Cancer Recurrence
|
6.7 percentage of participants
Interval 3.3 to 13.2
|
13.5 percentage of participants
Interval 10.8 to 16.7
|
3.6 percentage of participants
Interval 1.7 to 6.8
|
7.2 percentage of participants
Interval 2.7 to 13.4
|
—
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info \& either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy.
Prostate cancer anxiety was measured by the validated Memorial Anxiety Scale for Prostate Cancer (MAX-PC), with 18 questions assessing anxiety related to prostate cancer (11 items, total score 0 to 33), PSA testing (3 items, total score 0 to 9), and fear of recurrence (4 items, total score 0 to 12). The subscale for prostate cancer anxiety asks the patient to report how frequently comments about prostate cancer were true for them during the past week (not at all, rarely, sometimes, or often). The subscale for PSA testing anxiety asks the patient to indicate how frequently situations have ever been true for them. The subscale for anxiety related to prostate cancer recurrence asks the patient to indicate how much they agree or disagree with statements about their own health during the past week. A higher score in each subscale indicates more anxiety.
Outcome measures
| Measure |
Active Surveillance
n=390 Participants
Patients placed on active surveillance following diagnosis of prostate cancer. Active surveillance was defined with medical records stating this as the plan.
|
Stereotactic Body Radiation Therapy
n=104 Participants
Patients who received initial treatment with stereotactic body radiation therapy (SBRT).
|
Radical Prostatectomy
n=547 Participants
Patients who received initial treatment with radical prostatectomy.
|
External Body Radiation Therapy
n=247 Participants
Patients who received initial treatment with external body radiation therapy (EBRT).
|
Brachytherapy
n=125 Participants
Patients who received initial treatment with brachytherapy.
|
|---|---|---|---|---|---|
|
Prostate Cancer Anxiety
PSA test anxiety - 36-months
|
1.2 score on a scale
Interval 1.1 to 1.3
|
1.1 score on a scale
Interval 1.0 to 1.2
|
1.2 score on a scale
Interval 1.2 to 1.2
|
1.2 score on a scale
Interval 1.1 to 1.3
|
1.1 score on a scale
Interval 1.0 to 1.2
|
|
Prostate Cancer Anxiety
Prostate cancer anxiety - 12-months
|
1.6 score on a scale
Interval 1.5 to 1.7
|
1.4 score on a scale
Interval 1.3 to 1.5
|
1.6 score on a scale
Interval 1.5 to 1.7
|
1.6 score on a scale
Interval 1.5 to 1.7
|
1.5 score on a scale
Interval 1.4 to 1.6
|
|
Prostate Cancer Anxiety
Prostate cancer anxiety - 24-months
|
1.5 score on a scale
Interval 1.4 to 1.6
|
1.3 score on a scale
Interval 1.2 to 1.4
|
1.5 score on a scale
Interval 1.4 to 1.6
|
1.5 score on a scale
Interval 1.4 to 1.6
|
1.4 score on a scale
Interval 1.3 to 1.5
|
|
Prostate Cancer Anxiety
Prostate cancer anxiety - 36-months
|
1.4 score on a scale
Interval 1.3 to 1.5
|
1.3 score on a scale
Interval 1.2 to 1.4
|
1.5 score on a scale
Interval 1.4 to 1.6
|
1.5 score on a scale
Interval 1.4 to 1.6
|
1.3 score on a scale
Interval 1.2 to 1.4
|
|
Prostate Cancer Anxiety
Prostate cancer anxiety - 48-months
|
1.5 score on a scale
Interval 1.4 to 1.6
|
1.2 score on a scale
Interval 1.1 to 1.6
|
1.5 score on a scale
Interval 1.4 to 1.6
|
1.5 score on a scale
Interval 1.4 to 1.6
|
1.3 score on a scale
Interval 1.2 to 1.4
|
|
Prostate Cancer Anxiety
Recurrence anxiety - 12-months
|
—
|
1.5 score on a scale
Interval 1.4 to 1.6
|
1.7 score on a scale
Interval 1.6 to 1.8
|
1.9 score on a scale
Interval 1.8 to 2.0
|
1.8 score on a scale
Interval 1.7 to 1.9
|
|
Prostate Cancer Anxiety
Recurrence anxiety - 24-months
|
—
|
1.6 score on a scale
Interval 1.5 to 1.7
|
1.7 score on a scale
Interval 1.6 to 1.8
|
1.8 score on a scale
Interval 1.7 to 1.9
|
1.7 score on a scale
Interval 1.6 to 1.8
|
|
Prostate Cancer Anxiety
Recurrence anxiety - 36-months
|
—
|
1.5 score on a scale
Interval 1.4 to 1.6
|
1.7 score on a scale
Interval 1.6 to 1.8
|
1.9 score on a scale
Interval 1.8 to 2.0
|
1.6 score on a scale
Interval 1.5 to 1.7
|
|
Prostate Cancer Anxiety
Recurrence anxiety - 48-months
|
—
|
1.5 score on a scale
Interval 1.4 to 1.6
|
1.7 score on a scale
Interval 1.6 to 1.8
|
1.8 score on a scale
Interval 1.7 to 1.9
|
1.6 score on a scale
Interval 1.5 to 1.7
|
|
Prostate Cancer Anxiety
PSA test anxiety - 12-months
|
1.2 score on a scale
Interval 1.1 to 1.3
|
1.1 score on a scale
Interval 1.0 to 1.2
|
1.2 score on a scale
Interval 1.2 to 1.2
|
1.2 score on a scale
Interval 1.1 to 1.3
|
1.1 score on a scale
Interval 1.0 to 1.2
|
|
Prostate Cancer Anxiety
PSA test anxiety - 24-months
|
1.2 score on a scale
Interval 1.1 to 1.3
|
1.1 score on a scale
Interval 1.0 to 1.2
|
1.2 score on a scale
Interval 1.2 to 1.2
|
1.2 score on a scale
Interval 1.1 to 1.3
|
1.1 score on a scale
Interval 1.0 to 1.2
|
|
Prostate Cancer Anxiety
PSA test anxiety - 48-months
|
1.2 score on a scale
Interval 1.1 to 1.3
|
1.1 score on a scale
Interval 1.0 to 1.2
|
1.2 score on a scale
Interval 1.2 to 1.2
|
1.2 score on a scale
Interval 1.1 to 1.3
|
1.0 score on a scale
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info \& either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy.
Decisional regret was measured by a validated scale for prostate cancer. The five items of the decisional regret scale assess (on a Likert scale) a patient's feeling that he chose the wrong treatment, a wish to change the decision, or doubt about treatment value. Answers are converted to a score from 0 (no regret) to 100 (maximum regret). Decisional regret provides an assessment of the overall decisional and treatment experience from a patient perspective.
Outcome measures
| Measure |
Active Surveillance
n=390 Participants
Patients placed on active surveillance following diagnosis of prostate cancer. Active surveillance was defined with medical records stating this as the plan.
|
Stereotactic Body Radiation Therapy
n=104 Participants
Patients who received initial treatment with stereotactic body radiation therapy (SBRT).
|
Radical Prostatectomy
n=547 Participants
Patients who received initial treatment with radical prostatectomy.
|
External Body Radiation Therapy
n=247 Participants
Patients who received initial treatment with external body radiation therapy (EBRT).
|
Brachytherapy
n=125 Participants
Patients who received initial treatment with brachytherapy.
|
|---|---|---|---|---|---|
|
Decisional Regret
48-months
|
5.9 percentage of participants
Interval 3.0 to 10.3
|
7.5 percentage of participants
Interval 2.1 to 18.2
|
14.0 percentage of participants
Interval 10.3 to 18.6
|
12.5 percentage of participants
Interval 7.5 to 19.3
|
12.1 percentage of participants
Interval 5.4 to 22.5
|
|
Decisional Regret
12-months
|
9.2 percentage of participants
Interval 6.0 to 13.4
|
1.1 percentage of participants
Interval 0.0 to 5.7
|
15.0 percentage of participants
Interval 11.7 to 18.9
|
8.3 percentage of participants
Interval 4.8 to 13.1
|
9.7 percentage of participants
Interval 4.5 to 17.6
|
|
Decisional Regret
24-months
|
6.5 percentage of participants
Interval 3.7 to 10.5
|
7.6 percentage of participants
Interval 2.8 to 15.8
|
18.8 percentage of participants
Interval 14.9 to 23.1
|
8.6 percentage of participants
Interval 4.9 to 13.8
|
6.5 percentage of participants
Interval 2.1 to 14.5
|
|
Decisional Regret
36-months
|
5.6 percentage of participants
Interval 2.8 to 9.7
|
9.5 percentage of participants
Interval 3.9 to 18.5
|
13.9 percentage of participants
Interval 10.3 to 18.2
|
10.1 percentage of participants
Interval 5.7 to 16.4
|
9.5 percentage of participants
Interval 3.6 to 19.6
|
SECONDARY outcome
Timeframe: From date of diagnosis until date of death or end of follow-up up to 5 yearsPopulation: We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info \& either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy.
Percentage of patients who died within 5 years of follow-up.
Outcome measures
| Measure |
Active Surveillance
n=390 Participants
Patients placed on active surveillance following diagnosis of prostate cancer. Active surveillance was defined with medical records stating this as the plan.
|
Stereotactic Body Radiation Therapy
n=104 Participants
Patients who received initial treatment with stereotactic body radiation therapy (SBRT).
|
Radical Prostatectomy
n=547 Participants
Patients who received initial treatment with radical prostatectomy.
|
External Body Radiation Therapy
n=247 Participants
Patients who received initial treatment with external body radiation therapy (EBRT).
|
Brachytherapy
n=125 Participants
Patients who received initial treatment with brachytherapy.
|
|---|---|---|---|---|---|
|
5-year Mortality
|
9.5 percentage of participants
Interval 6.8 to 12.8
|
2.9 percentage of participants
Interval 0.6 to 8.2
|
3.3 percentage of participants
Interval 2.0 to 5.2
|
11.3 percentage of participants
Interval 7.7 to 16.0
|
4.8 percentage of participants
Interval 1.8 to 10.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 yearsPopulation: We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info \& either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy.
Number of physician and specialist visits during treatment, subsequent monitoring of recurrence and management of prostate cancer treatment-related morbidity. Assessed through analysis of healthcare claims linked to cohort data.
Outcome measures
| Measure |
Active Surveillance
n=88 Participants
Patients placed on active surveillance following diagnosis of prostate cancer. Active surveillance was defined with medical records stating this as the plan.
|
Stereotactic Body Radiation Therapy
n=211 Participants
Patients who received initial treatment with stereotactic body radiation therapy (SBRT).
|
Radical Prostatectomy
n=97 Participants
Patients who received initial treatment with radical prostatectomy.
|
External Body Radiation Therapy
n=79 Participants
Patients who received initial treatment with external body radiation therapy (EBRT).
|
Brachytherapy
n=35 Participants
Patients who received initial treatment with brachytherapy.
|
|---|---|---|---|---|---|
|
Number of Physician Visits During Follow-up
Total physician visits
|
7.6 visits
Standard Deviation 3.8
|
6.1 visits
Standard Deviation 3.7
|
5.6 visits
Standard Deviation 3.9
|
6.8 visits
Standard Deviation 3.6
|
6.0 visits
Standard Deviation 3.3
|
|
Number of Physician Visits During Follow-up
General practitioner visits
|
1.1 visits
Standard Deviation 1.4
|
0.8 visits
Standard Deviation 1.6
|
0.6 visits
Standard Deviation 1.4
|
1.1 visits
Standard Deviation 1.7
|
0.9 visits
Standard Deviation 1.8
|
|
Number of Physician Visits During Follow-up
Urology/Oncology visits
|
5.1 visits
Standard Deviation 3.3
|
4.1 visits
Standard Deviation 2.6
|
4.0 visits
Standard Deviation 2.9
|
4.4 visits
Standard Deviation 2.5
|
3.6 visits
Standard Deviation 2.2
|
|
Number of Physician Visits During Follow-up
Total prostate cancer visits
|
6.1 visits
Standard Deviation 3.3
|
4.6 visits
Standard Deviation 3.2
|
4.4 visits
Standard Deviation 3.4
|
5.0 visits
Standard Deviation 3.1
|
4.7 visits
Standard Deviation 2.7
|
|
Number of Physician Visits During Follow-up
Other specialists visits
|
0.1 visits
Standard Deviation 0.5
|
0.1 visits
Standard Deviation 0.6
|
0.1 visits
Standard Deviation 0.7
|
0.1 visits
Standard Deviation 0.5
|
0.0 visits
Standard Deviation 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 yearsPopulation: We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info \& either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy.
Number of diagnostic tests and procedures including biopsies, radiographic scans, laboratory tests, and procedures to assess cancer progression (active surveillance) or recurrence and work-up for treatment-related morbidity. Assessed through analysis of healthcare claims linked to cohort data.
Outcome measures
| Measure |
Active Surveillance
n=88 Participants
Patients placed on active surveillance following diagnosis of prostate cancer. Active surveillance was defined with medical records stating this as the plan.
|
Stereotactic Body Radiation Therapy
n=211 Participants
Patients who received initial treatment with stereotactic body radiation therapy (SBRT).
|
Radical Prostatectomy
n=97 Participants
Patients who received initial treatment with radical prostatectomy.
|
External Body Radiation Therapy
n=79 Participants
Patients who received initial treatment with external body radiation therapy (EBRT).
|
Brachytherapy
n=35 Participants
Patients who received initial treatment with brachytherapy.
|
|---|---|---|---|---|---|
|
Number of Diagnostic Tests and Procedures During Follow-up
Total tests and procedures
|
6.0 tests or procedures
Standard Deviation 2.7
|
5.1 tests or procedures
Standard Deviation 2.9
|
5.5 tests or procedures
Standard Deviation 3.3
|
4.7 tests or procedures
Standard Deviation 2.4
|
4.8 tests or procedures
Standard Deviation 2.5
|
|
Number of Diagnostic Tests and Procedures During Follow-up
PSA test
|
4.6 tests or procedures
Standard Deviation 2.3
|
4.7 tests or procedures
Standard Deviation 2.8
|
5.3 tests or procedures
Standard Deviation 3.2
|
4.3 tests or procedures
Standard Deviation 2.4
|
4.1 tests or procedures
Standard Deviation 2.4
|
|
Number of Diagnostic Tests and Procedures During Follow-up
Other tests and procedures
|
1.4 tests or procedures
Standard Deviation 1.3
|
0.4 tests or procedures
Standard Deviation 0.6
|
0.2 tests or procedures
Standard Deviation 0.5
|
0.4 tests or procedures
Standard Deviation 0.6
|
0.7 tests or procedures
Standard Deviation 0.7
|
Adverse Events
NC ProCESS Cohort
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place