North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS)

• Sponsor: UNC Lineberger Comprehensive Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02564120
• Collaborator: Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 1,556
• Location: 1
• Duration (Months): 96
• Patients Per Site Per Month: 16.2

Study Details

Study Description

Brief Summary

NC ProCESS is a cohort of patients from diverse backgrounds diagnosed 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 start treatment, and are then followed prospectively through treatment and then afterwards. This observational study collects information on quality of life, cancer control, and health care received inclusive of treatment and management of subsequent effects including complications and recurrence. The objective of this study is to examine comparative outcomes among different modern prostate cancer treatment options in this cohort of patients.

Condition or Disease	Intervention/Treatment	Phase
Cancer of Prostate; Cancer of the Prostate; Prostate Cancer; Prostatic Cancer

Detailed Description

Localized prostate cancer treatment options is consistently a "highest priority" comparative effectiveness research (CER) topic according to the Institute of Medicine, Agency for Healthcare Research and Quality (AHRQ), and other summary reports. Patients urgently need information on the comparative outcomes of modern treatment options to guide decision-making for this disease that causes significant burden based on its high prevalence, mortality and treatment effects on quality of life. The status quo as it pertains to prostate cancer is significant overtreatment causing potential patient harm, rapid diffusion of new/expensive technologies without proven benefit and patients lacking high quality research evidence to balance direct-to-consumer advertising and guide individualized decision-making.

NC ProCESS is a population-based cohort designed specifically to address well-described knowledge gaps. It was designed in close collaboration with the unique AHRQ consortium stakeholder group, which included representatives from patients, clinicians and policymakers. Stakeholders helped define study design to emphasize "real-world" patients and select patient-centered and relevant outcomes, and have been involved throughout assembly of this patient cohort. The diverse cohort is well-represented by "hard to reach" patients; enrollment before treatment avoids biases with participation and recall. As clinical trials are not feasible to address the central questions in prostate cancer CER, this prospective study will yield the highest level of evidence to inform patients and other stakeholders. With an assembled cohort, this study is necessary to examine comparative outcomes.

Study Design

• Study Type: Observational
• Actual Enrollment: 1556 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS)
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Dec 31, 2018

Outcome Measures

Primary Outcome Measures

1. Cancer-specific Quality of Life [4 years]

   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."

2. Overall Quality of Life [4 years]

   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.

3. Prostate Cancer Recurrence [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.]

   Percentage of patients who had a recurrence of prostate cancer during 5 years of follow-up.

Secondary Outcome Measures

1. Prostate Cancer Anxiety [4 years]

   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.

2. Decisional Regret [4 years]

   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.

3. 5-year Mortality [From date of diagnosis until date of death or end of follow-up up to 5 years]

   Percentage of patients who died within 5 years of follow-up.

Other Outcome Measures

1. Number of Physician Visits During Follow-up [4 years]

   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.

2. Number of Diagnostic Tests and Procedures During Follow-up [4 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

• UNC Lineberger Comprehensive Cancer Center
• Patient-Centered Outcomes Research Institute

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 1, 2019

More Information

Publications

None provided.

• Responsible Party: UNC Lineberger Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT02564120
• Other Study ID Numbers: UNC-10-1483
• First Posted: Sep 30, 2015
• Last Update Posted: Apr 28, 2020
• Last Verified: Apr 1, 2020

• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Arm/Group Title	NC ProCESS Cohort
Arm/Group Description	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.
Period Title: Overall Study
STARTED	1556
COMPLETED	1110
NOT COMPLETED	446

Baseline Characteristics

Arm/Group Title	Active Surveillance	SBRT	Radical Prostatectomy	EBRT	Brachytherapy	Total
Arm/Group Description	Men placed on active surveillance (i.e., did not receive immediate treatment)	Men who received stereotactic body radiation therapy	Men treated with radical prostatectomy (i.e., surgery)	Men treated with external beam radiation therapy	Men treated with brachytherapy	Total of all reporting groups
Overall Participants	390	104	547	247	125	1413
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.3 (7.5)	65.3 (6.8)	61.1 (7.0)	66.8 (7.1)	64.6 (7.3)	64.2 (7.2)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Male	390 100%	104 100%	547 100%	247 100%	125 100%	1413 100%
Race/Ethnicity, Customized (Count of Participants)
White	287 73.6%	97 93.3%	382 69.8%	153 61.9%	90 72%	1009 71.4%
African American	97 24.9%	3 2.9%	143 26.1%	83 33.6%	33 26.4%	359 25.4%
Other	6 1.5%	4 3.8%	22 4%	11 4.5%	2 1.6%	45 3.2%
Region of Enrollment (participants) [Number]
United States	390 100%	104 100%	547 100%	247 100%	125 100%	1413 100%

Outcome Measures

1. Primary Outcome

Title	Cancer-specific Quality of Life
Description	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."
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Active Surveillance	Stereotactic Body Radiation Therapy	Radical Prostatectomy	External Body Radiation Therapy	Brachytherapy
Arm/Group Description	Patients placed on active surveillance following diagnosis of prostate cancer. Active surveillance was defined with medical records stating this as the plan.	Patients who received initial treatment with stereotactic body radiation therapy (SBRT).	Patients who received initial treatment with radical prostatectomy.	Patients who received initial treatment with external body radiation therapy (EBRT).	Patients who received initial treatment with brachytherapy.
Measure Participants	390	104	547	247	125
Sexual Dysfunction - Baseline	44.7	42.0	35.9	52.1	44.9
Sexual Dysfunction - 3-months	44.4	42.1	78.0	65.2	59.0
Sexual Dysfunction - 12-months	48.2	48.2	70.8	62.8	59.3
Sexual Dysfunction - 24-months	55.2	48.8	68.2	64.9	62.3
Sexual Dysfunction - 36-months	50.9	52.3	68.6	64.2	63.7
Sexual Dysfunction - 48-months	56.5	53.9	69.7	66.1	64.0
Urinary Obstruction & Irritation - Baseline	23.4	22.9	23.3	24.2	17.5
Urinary Obstruction & Irritation - 3-months	23.2	24.3	27.0	35.6	40.3
Urinary Obstruction & Irritation - 12-months	25.9	29.5	21.4	25.3	27.6
Urinary Obstruction & Irritation - 24-months	25.1	26.4	19.4	23.7	26.9
Urinary Obstruction & Irritation - 36-months	23.7	22.8	19.5	22.5	19.5
Urinary Obstruction & Irritation - 48-months	24.3	22.9	19.2	23.8	22.2
Urinary Incontinence - Baseline	11.0	8.3	8.6	14.1	6.0
Urinary Incontinence - 3-months	12.3	12.7	44.0	17.6	15.1
Urinary Incontinence - 12-months	14.0	15.2	31.5	18.7	13.9
Urinary Incontinence -24-months	18.6	14.8	29.7	20.1	16.3
Urinary Incontinence - 36-months	15.9	15.1	28.8	20.4	21.6
Urinary Incontinence - 48-months	19.9	11.5	30.8	19.9	16.5
Bowel Problems - Baseline	6.1	5.5	5.8	7.5	4.8
Bowel Problems - 3-months	7.1	5.6	7.1	12.6	9.0
Bowel Problems - 12-months	7.1	5.9	6.2	9.4	7.2
Bowel Problems - 24-months	6.2	5.0	5.6	9.5	6.1
Bowel Problems - 36-months	6.9	5.9	5.6	8.4	5.8
Bowel Problems - 48-months	7.1	4.4	5.3	7.1	7.4

2. Primary Outcome

Title	Overall Quality of Life
Description	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.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Active Surveillance	Stereotactic Body Radiation Therapy	Radical Prostatectomy	External Body Radiation Therapy	Brachytherapy
Arm/Group Description	Patients placed on active surveillance following diagnosis of prostate cancer. Active surveillance was defined with medical records stating this as the plan.	Patients who received initial treatment with stereotactic body radiation therapy (SBRT).	Patients who received initial treatment with radical prostatectomy.	Patients who received initial treatment with external body radiation therapy (EBRT).	Patients who received initial treatment with brachytherapy.
Measure Participants	390	104	547	247	125
Physical Health - Baseline	47.8	52.1	51.1	47.6	50.4
Physical Health - 3-months	47.6	50.8	49.4	46.4	49.0
Physical Health - 12-months	48.2	50.8	49.8	46.9	48.7
Physical Health - 24-months	46.8	51.2	48.6	46.2	47.3
Physical Health - 36-months	46.8	50.8	49.0	46.6	48.0
Physical Health - 48-months	46.1	50.7	48.4	45.9	45.8
Mental Health - Baseline	54.6	53.2	52.0	52.9	54.8
Mental Health - 3-months	55.0	54.8	52.6	52.9	53.4
Mental Health - 12-months	54.2	55.2	54.1	54.0	55.6
Mental Health - 24-months	55.6	54.7	54.1	54.1	55.8
Mental Health - 36-months	55.3	54.5	53.9	54.2	55.4
Mental Health - 48-months	54.9	55.1	54.5	54.0	56.2

3. Primary Outcome

Title	Prostate Cancer Recurrence
Description	Percentage of patients who had a recurrence of prostate cancer during 5 years of follow-up.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Stereotactic Body Radiation Therapy	Radical Prostatectomy	External Body Radiation Therapy	Brachytherapy
Arm/Group Description	Patients who received initial treatment with stereotactic body radiation therapy (SBRT).	Patients who received initial treatment with radical prostatectomy.	Patients who received initial treatment with external body radiation therapy (EBRT).	Patients who received initial treatment with brachytherapy.
Measure Participants	104	547	247	125
Number (95% Confidence Interval) [percentage of participants]	6.7 1.7%	13.5 13%	3.6 0.7%	7.2 2.9%

4. Secondary Outcome

Title	Prostate Cancer Anxiety
Description	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.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Active Surveillance	Stereotactic Body Radiation Therapy	Radical Prostatectomy	External Body Radiation Therapy	Brachytherapy
Arm/Group Description	Patients placed on active surveillance following diagnosis of prostate cancer. Active surveillance was defined with medical records stating this as the plan.	Patients who received initial treatment with stereotactic body radiation therapy (SBRT).	Patients who received initial treatment with radical prostatectomy.	Patients who received initial treatment with external body radiation therapy (EBRT).	Patients who received initial treatment with brachytherapy.
Measure Participants	390	104	547	247	125
Prostate cancer anxiety - 12-months	1.6	1.4	1.6	1.6	1.5
Prostate cancer anxiety - 24-months	1.5	1.3	1.5	1.5	1.4
Prostate cancer anxiety - 36-months	1.4	1.3	1.5	1.5	1.3
Prostate cancer anxiety - 48-months	1.5	1.2	1.5	1.5	1.3
Recurrence anxiety - 12-months	1.5	1.7	1.9	1.8
Recurrence anxiety - 24-months	1.6	1.7	1.8	1.7
Recurrence anxiety - 36-months	1.5	1.7	1.9	1.6
Recurrence anxiety - 48-months	1.5	1.7	1.8	1.6
PSA test anxiety - 12-months	1.2	1.1	1.2	1.2	1.1
PSA test anxiety - 24-months	1.2	1.1	1.2	1.2	1.1
PSA test anxiety - 36-months	1.2	1.1	1.2	1.2	1.1
PSA test anxiety - 48-months	1.2	1.1	1.2	1.2	1.0

5. Secondary Outcome

Title	Decisional Regret
Description	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.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Active Surveillance	Stereotactic Body Radiation Therapy	Radical Prostatectomy	External Body Radiation Therapy	Brachytherapy
Arm/Group Description	Patients placed on active surveillance following diagnosis of prostate cancer. Active surveillance was defined with medical records stating this as the plan.	Patients who received initial treatment with stereotactic body radiation therapy (SBRT).	Patients who received initial treatment with radical prostatectomy.	Patients who received initial treatment with external body radiation therapy (EBRT).	Patients who received initial treatment with brachytherapy.
Measure Participants	390	104	547	247	125
12-months	9.2 2.4%	1.1 1.1%	15.0 2.7%	8.3 3.4%	9.7 7.8%
24-months	6.5 1.7%	7.6 7.3%	18.8 3.4%	8.6 3.5%	6.5 5.2%
36-months	5.6 1.4%	9.5 9.1%	13.9 2.5%	10.1 4.1%	9.5 7.6%
48-months	5.9 1.5%	7.5 7.2%	14.0 2.6%	12.5 5.1%	12.1 9.7%

6. Secondary Outcome

Title	5-year Mortality
Description	Percentage of patients who died within 5 years of follow-up.
Time Frame	From date of diagnosis until date of death or end of follow-up up to 5 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Active Surveillance	Stereotactic Body Radiation Therapy	Radical Prostatectomy	External Body Radiation Therapy	Brachytherapy
Arm/Group Description	Patients placed on active surveillance following diagnosis of prostate cancer. Active surveillance was defined with medical records stating this as the plan.	Patients who received initial treatment with stereotactic body radiation therapy (SBRT).	Patients who received initial treatment with radical prostatectomy.	Patients who received initial treatment with external body radiation therapy (EBRT).	Patients who received initial treatment with brachytherapy.
Measure Participants	390	104	547	247	125
Number (95% Confidence Interval) [percentage of participants]	9.5 2.4%	2.9 2.8%	3.3 0.6%	11.3 4.6%	4.8 3.8%

7. Other Pre-specified Outcome

Title	Number of Physician Visits During Follow-up
Description	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.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Active Surveillance	Any Active Treatment	Radical Prostatectomy	SBRT/EBRT	Brachytherapy
Arm/Group Description	Patients placed on active surveillance following diagnosis of prostate cancer. Active surveillance was defined with medical records stating this as the plan.	Patients who received initial treatment with surgery or radiation, including brachytherapy or SBRT.	Patients who received initial treatment with radical prostatectomy.	Patients who received initial treatment with stereotactic body radiation therapy (SBRT) or external body radiation therapy (EBRT).	Patients who received initial treatment with brachytherapy.
Measure Participants	88	211	97	79	35
Total prostate cancer visits	6.1 (3.3)	4.6 (3.2)	4.4 (3.4)	5.0 (3.1)	4.7 (2.7)
Total physician visits	7.6 (3.8)	6.1 (3.7)	5.6 (3.9)	6.8 (3.6)	6.0 (3.3)
General practitioner visits	1.1 (1.4)	0.8 (1.6)	0.6 (1.4)	1.1 (1.7)	0.9 (1.8)
Urology/Oncology visits	5.1 (3.3)	4.1 (2.6)	4.0 (2.9)	4.4 (2.5)	3.6 (2.2)
Other specialists visits	0.1 (0.5)	0.1 (0.6)	0.1 (0.7)	0.1 (0.5)	0.0 (0.0)

8. Other Pre-specified Outcome

Title	Number of Diagnostic Tests and Procedures During Follow-up
Description	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.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Active Surveillance	Any Active Treatment	Radical Prostatectomy	SBRT/EBRT	Brachytherapy
Arm/Group Description	Patients placed on active surveillance following diagnosis of prostate cancer. Active surveillance was defined with medical records stating this as the plan.	Patients who received initial treatment with surgery or radiation, including brachytherapy or SBRT.	Patients who received initial treatment with radical prostatectomy.	Patients who received initial treatment with stereotactic body radiation therapy (SBRT) or external body radiation therapy (EBRT).	Patients who received initial treatment with brachytherapy.
Measure Participants	88	211	97	79	35
PSA test	4.6 (2.3)	4.7 (2.8)	5.3 (3.2)	4.3 (2.4)	4.1 (2.4)
Other tests and procedures	1.4 (1.3)	0.4 (0.6)	0.2 (0.5)	0.4 (0.6)	0.7 (0.7)
Total tests and procedures	6.0 (2.7)	5.1 (2.9)	5.5 (3.3)	4.7 (2.4)	4.8 (2.5)

Adverse Events

Time Frame	5 years
Adverse Event Reporting Description	Serious and other (not including serious) adverse events were not monitored/assessed.
Arm/Group Title	NC ProCESS Cohort
Arm/Group Description	NC ProCESS cohort is a population-based, prospective prostate cancer patient cohort.
All Cause Mortality
	NC ProCESS Cohort
	Affected / at Risk (%)	# Events
Total	58/1110 (5.2%)
Serious Adverse Events
	NC ProCESS Cohort
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	NC ProCESS Cohort
	Affected / at Risk (%)	# Events
Total	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.