Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02564120
Enrollment
1556
Registered
2015-09-30
Start date
2011-01-31
Completion date
2018-12-31
Last updated
2020-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of Prostate, Cancer of the Prostate, Prostate Cancer, Prostatic Cancer

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.

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.

Interventions

None listed

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
UNC Lineberger Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
35 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Prostate Cancer RecurrenceFrom 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.
Overall Quality of Life4 yearsShort 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.
Cancer-specific Quality of Life4 yearsProstate 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.

Secondary

MeasureTime frameDescription
5-year MortalityFrom date of diagnosis until date of death or end of follow-up up to 5 yearsPercentage of patients who died within 5 years of follow-up.
Prostate Cancer Anxiety4 yearsProstate 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.
Decisional Regret4 yearsDecisional 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.

Other

MeasureTime frameDescription
Number of Physician Visits During Follow-up4 yearsNumber 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.
Number of Diagnostic Tests and Procedures During Follow-up4 yearsNumber 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Active Surveillance
Men placed on active surveillance (i.e., did not receive immediate treatment)
390
SBRT
Men who received stereotactic body radiation therapy
104
Radical Prostatectomy
Men treated with radical prostatectomy (i.e., surgery)
547
EBRT
Men treated with external beam radiation therapy
247
Brachytherapy
Men treated with brachytherapy
125
Total1,413

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDeath58
Overall StudyDid not return release forms160
Overall StudyOther medical condition24
Overall StudyWithdrawal by Subject204

Baseline characteristics

CharacteristicSBRTRadical ProstatectomyEBRTActive SurveillanceBrachytherapyTotal
Age, Continuous65.3 years
STANDARD_DEVIATION 6.8
61.1 years
STANDARD_DEVIATION 7
66.8 years
STANDARD_DEVIATION 7.1
66.3 years
STANDARD_DEVIATION 7.5
64.6 years
STANDARD_DEVIATION 7.3
64.2 years
STANDARD_DEVIATION 7.2
Race/Ethnicity, Customized
African American
3 Participants143 Participants83 Participants97 Participants33 Participants359 Participants
Race/Ethnicity, Customized
Other
4 Participants22 Participants11 Participants6 Participants2 Participants45 Participants
Race/Ethnicity, Customized
White
97 Participants382 Participants153 Participants287 Participants90 Participants1009 Participants
Region of Enrollment
United States
104 participants547 participants247 participants390 participants125 participants1413 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Male
104 Participants547 Participants247 Participants390 Participants125 Participants1413 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
58 / 1,110
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Cancer-specific Quality of Life

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

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.

ArmMeasureGroupValue (MEAN)
Active SurveillanceCancer-specific Quality of LifeSexual Dysfunction - 3-months44.4 score on a scale
Active SurveillanceCancer-specific Quality of LifeBowel Problems - 3-months7.1 score on a scale
Active SurveillanceCancer-specific Quality of LifeSexual Dysfunction - 36-months50.9 score on a scale
Active SurveillanceCancer-specific Quality of LifeUrinary Obstruction & Irritation - 24-months25.1 score on a scale
Active SurveillanceCancer-specific Quality of LifeSexual Dysfunction - Baseline44.7 score on a scale
Active SurveillanceCancer-specific Quality of LifeBowel Problems - 24-months6.2 score on a scale
Active SurveillanceCancer-specific Quality of LifeBowel Problems - Baseline6.1 score on a scale
Active SurveillanceCancer-specific Quality of LifeSexual Dysfunction - 48-months56.5 score on a scale
Active SurveillanceCancer-specific Quality of LifeUrinary Incontinence - 12-months14.0 score on a scale
Active SurveillanceCancer-specific Quality of LifeUrinary Incontinence - Baseline11.0 score on a scale
Active SurveillanceCancer-specific Quality of LifeSexual Dysfunction - 12-months48.2 score on a scale
Active SurveillanceCancer-specific Quality of LifeUrinary Obstruction & Irritation - 48-months24.3 score on a scale
Active SurveillanceCancer-specific Quality of LifeUrinary Incontinence - 3-months12.3 score on a scale
Active SurveillanceCancer-specific Quality of LifeBowel Problems - 12-months7.1 score on a scale
Active SurveillanceCancer-specific Quality of LifeUrinary Incontinence - 48-months19.9 score on a scale
Active SurveillanceCancer-specific Quality of LifeSexual Dysfunction - 24-months55.2 score on a scale
Active SurveillanceCancer-specific Quality of LifeUrinary Obstruction & Irritation - 3-months23.2 score on a scale
Active SurveillanceCancer-specific Quality of LifeUrinary Obstruction & Irritation - 36-months23.7 score on a scale
Active SurveillanceCancer-specific Quality of LifeBowel Problems - 48-months7.1 score on a scale
Active SurveillanceCancer-specific Quality of LifeUrinary Incontinence - 36-months15.9 score on a scale
Active SurveillanceCancer-specific Quality of LifeUrinary Obstruction & Irritation - 12-months25.9 score on a scale
Active SurveillanceCancer-specific Quality of LifeUrinary Obstruction & Irritation - Baseline23.4 score on a scale
Active SurveillanceCancer-specific Quality of LifeBowel Problems - 36-months6.9 score on a scale
Active SurveillanceCancer-specific Quality of LifeUrinary Incontinence -24-months18.6 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeUrinary Incontinence -24-months14.8 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeUrinary Obstruction & Irritation - 24-months26.4 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeUrinary Incontinence - 12-months15.2 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeUrinary Obstruction & Irritation - 36-months22.8 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeSexual Dysfunction - 3-months42.1 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeUrinary Incontinence - Baseline8.3 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeUrinary Obstruction & Irritation - 48-months22.9 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeUrinary Incontinence - 3-months12.7 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeBowel Problems - 24-months5.0 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeSexual Dysfunction - 12-months48.2 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeBowel Problems - 48-months4.4 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeBowel Problems - 12-months5.9 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeSexual Dysfunction - 24-months48.8 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeBowel Problems - 3-months5.6 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeSexual Dysfunction - 36-months52.3 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeBowel Problems - Baseline5.5 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeSexual Dysfunction - 48-months53.9 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeSexual Dysfunction - Baseline42.0 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeUrinary Obstruction & Irritation - Baseline22.9 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeUrinary Incontinence - 48-months11.5 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeUrinary Incontinence - 36-months15.1 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeUrinary Obstruction & Irritation - 3-months24.3 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeBowel Problems - 36-months5.9 score on a scale
Stereotactic Body Radiation TherapyCancer-specific Quality of LifeUrinary Obstruction & Irritation - 12-months29.5 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeUrinary Incontinence - 48-months30.8 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeBowel Problems - 36-months5.6 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeSexual Dysfunction - Baseline35.9 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeSexual Dysfunction - 3-months78.0 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeSexual Dysfunction - 12-months70.8 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeSexual Dysfunction - 24-months68.2 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeSexual Dysfunction - 36-months68.6 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeSexual Dysfunction - 48-months69.7 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeUrinary Obstruction & Irritation - Baseline23.3 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeUrinary Obstruction & Irritation - 3-months27.0 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeUrinary Obstruction & Irritation - 12-months21.4 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeUrinary Obstruction & Irritation - 24-months19.4 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeUrinary Obstruction & Irritation - 36-months19.5 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeUrinary Obstruction & Irritation - 48-months19.2 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeUrinary Incontinence - Baseline8.6 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeUrinary Incontinence - 3-months44.0 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeUrinary Incontinence - 12-months31.5 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeUrinary Incontinence -24-months29.7 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeUrinary Incontinence - 36-months28.8 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeBowel Problems - Baseline5.8 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeBowel Problems - 3-months7.1 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeBowel Problems - 12-months6.2 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeBowel Problems - 24-months5.6 score on a scale
Radical ProstatectomyCancer-specific Quality of LifeBowel Problems - 48-months5.3 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeUrinary Obstruction & Irritation - 12-months25.3 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeSexual Dysfunction - Baseline52.1 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeSexual Dysfunction - 24-months64.9 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeUrinary Incontinence - 36-months20.4 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeBowel Problems - 3-months12.6 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeUrinary Incontinence -24-months20.1 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeUrinary Obstruction & Irritation - Baseline24.2 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeSexual Dysfunction - 12-months62.8 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeUrinary Obstruction & Irritation - 3-months35.6 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeBowel Problems - 12-months9.4 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeSexual Dysfunction - 48-months66.1 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeUrinary Incontinence - 48-months19.9 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeSexual Dysfunction - 3-months65.2 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeBowel Problems - 48-months7.1 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeUrinary Obstruction & Irritation - 48-months23.8 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeUrinary Obstruction & Irritation - 24-months23.7 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeUrinary Incontinence - 12-months18.7 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeUrinary Obstruction & Irritation - 36-months22.5 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeBowel Problems - 24-months9.5 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeUrinary Incontinence - Baseline14.1 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeSexual Dysfunction - 36-months64.2 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeBowel Problems - 36-months8.4 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeUrinary Incontinence - 3-months17.6 score on a scale
External Body Radiation TherapyCancer-specific Quality of LifeBowel Problems - Baseline7.5 score on a scale
BrachytherapyCancer-specific Quality of LifeUrinary Incontinence - 3-months15.1 score on a scale
BrachytherapyCancer-specific Quality of LifeSexual Dysfunction - Baseline44.9 score on a scale
BrachytherapyCancer-specific Quality of LifeUrinary Incontinence - 12-months13.9 score on a scale
BrachytherapyCancer-specific Quality of LifeUrinary Obstruction & Irritation - 12-months27.6 score on a scale
BrachytherapyCancer-specific Quality of LifeUrinary Incontinence -24-months16.3 score on a scale
BrachytherapyCancer-specific Quality of LifeUrinary Obstruction & Irritation - 3-months40.3 score on a scale
BrachytherapyCancer-specific Quality of LifeUrinary Obstruction & Irritation - Baseline17.5 score on a scale
BrachytherapyCancer-specific Quality of LifeBowel Problems - 36-months5.8 score on a scale
BrachytherapyCancer-specific Quality of LifeUrinary Incontinence - 36-months21.6 score on a scale
BrachytherapyCancer-specific Quality of LifeUrinary Incontinence - 48-months16.5 score on a scale
BrachytherapyCancer-specific Quality of LifeSexual Dysfunction - 36-months63.7 score on a scale
BrachytherapyCancer-specific Quality of LifeBowel Problems - Baseline4.8 score on a scale
BrachytherapyCancer-specific Quality of LifeSexual Dysfunction - 24-months62.3 score on a scale
BrachytherapyCancer-specific Quality of LifeSexual Dysfunction - 48-months64.0 score on a scale
BrachytherapyCancer-specific Quality of LifeBowel Problems - 3-months9.0 score on a scale
BrachytherapyCancer-specific Quality of LifeSexual Dysfunction - 12-months59.3 score on a scale
BrachytherapyCancer-specific Quality of LifeBowel Problems - 48-months7.4 score on a scale
BrachytherapyCancer-specific Quality of LifeBowel Problems - 12-months7.2 score on a scale
BrachytherapyCancer-specific Quality of LifeSexual Dysfunction - 3-months59.0 score on a scale
BrachytherapyCancer-specific Quality of LifeUrinary Obstruction & Irritation - 48-months22.2 score on a scale
BrachytherapyCancer-specific Quality of LifeUrinary Obstruction & Irritation - 36-months19.5 score on a scale
BrachytherapyCancer-specific Quality of LifeUrinary Incontinence - Baseline6.0 score on a scale
BrachytherapyCancer-specific Quality of LifeBowel Problems - 24-months6.1 score on a scale
BrachytherapyCancer-specific Quality of LifeUrinary Obstruction & Irritation - 24-months26.9 score on a scale
Primary

Overall Quality of Life

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

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.

ArmMeasureGroupValue (MEAN)
Active SurveillanceOverall Quality of LifePhysical Health - 3-months47.6 score on a scale
Active SurveillanceOverall Quality of LifePhysical Health - Baseline47.8 score on a scale
Active SurveillanceOverall Quality of LifePhysical Health - 24-months46.8 score on a scale
Active SurveillanceOverall Quality of LifePhysical Health - 36-months46.8 score on a scale
Active SurveillanceOverall Quality of LifeMental Health - 48-months54.9 score on a scale
Active SurveillanceOverall Quality of LifePhysical Health - 12-months48.2 score on a scale
Active SurveillanceOverall Quality of LifeMental Health - 12-months54.2 score on a scale
Active SurveillanceOverall Quality of LifeMental Health - 36-months55.3 score on a scale
Active SurveillanceOverall Quality of LifeMental Health - 24-months55.6 score on a scale
Active SurveillanceOverall Quality of LifeMental Health - 3-months55.0 score on a scale
Active SurveillanceOverall Quality of LifePhysical Health - 48-months46.1 score on a scale
Active SurveillanceOverall Quality of LifeMental Health - Baseline54.6 score on a scale
Stereotactic Body Radiation TherapyOverall Quality of LifeMental Health - Baseline53.2 score on a scale
Stereotactic Body Radiation TherapyOverall Quality of LifeMental Health - 3-months54.8 score on a scale
Stereotactic Body Radiation TherapyOverall Quality of LifeMental Health - 12-months55.2 score on a scale
Stereotactic Body Radiation TherapyOverall Quality of LifePhysical Health - Baseline52.1 score on a scale
Stereotactic Body Radiation TherapyOverall Quality of LifeMental Health - 48-months55.1 score on a scale
Stereotactic Body Radiation TherapyOverall Quality of LifePhysical Health - 3-months50.8 score on a scale
Stereotactic Body Radiation TherapyOverall Quality of LifePhysical Health - 48-months50.7 score on a scale
Stereotactic Body Radiation TherapyOverall Quality of LifePhysical Health - 12-months50.8 score on a scale
Stereotactic Body Radiation TherapyOverall Quality of LifePhysical Health - 24-months51.2 score on a scale
Stereotactic Body Radiation TherapyOverall Quality of LifeMental Health - 36-months54.5 score on a scale
Stereotactic Body Radiation TherapyOverall Quality of LifePhysical Health - 36-months50.8 score on a scale
Stereotactic Body Radiation TherapyOverall Quality of LifeMental Health - 24-months54.7 score on a scale
Radical ProstatectomyOverall Quality of LifePhysical Health - 24-months48.6 score on a scale
Radical ProstatectomyOverall Quality of LifeMental Health - Baseline52.0 score on a scale
Radical ProstatectomyOverall Quality of LifeMental Health - 12-months54.1 score on a scale
Radical ProstatectomyOverall Quality of LifePhysical Health - Baseline51.1 score on a scale
Radical ProstatectomyOverall Quality of LifePhysical Health - 36-months49.0 score on a scale
Radical ProstatectomyOverall Quality of LifeMental Health - 36-months53.9 score on a scale
Radical ProstatectomyOverall Quality of LifeMental Health - 24-months54.1 score on a scale
Radical ProstatectomyOverall Quality of LifePhysical Health - 48-months48.4 score on a scale
Radical ProstatectomyOverall Quality of LifeMental Health - 3-months52.6 score on a scale
Radical ProstatectomyOverall Quality of LifePhysical Health - 12-months49.8 score on a scale
Radical ProstatectomyOverall Quality of LifePhysical Health - 3-months49.4 score on a scale
Radical ProstatectomyOverall Quality of LifeMental Health - 48-months54.5 score on a scale
External Body Radiation TherapyOverall Quality of LifeMental Health - 24-months54.1 score on a scale
External Body Radiation TherapyOverall Quality of LifePhysical Health - Baseline47.6 score on a scale
External Body Radiation TherapyOverall Quality of LifePhysical Health - 3-months46.4 score on a scale
External Body Radiation TherapyOverall Quality of LifePhysical Health - 12-months46.9 score on a scale
External Body Radiation TherapyOverall Quality of LifePhysical Health - 24-months46.2 score on a scale
External Body Radiation TherapyOverall Quality of LifePhysical Health - 36-months46.6 score on a scale
External Body Radiation TherapyOverall Quality of LifePhysical Health - 48-months45.9 score on a scale
External Body Radiation TherapyOverall Quality of LifeMental Health - Baseline52.9 score on a scale
External Body Radiation TherapyOverall Quality of LifeMental Health - 3-months52.9 score on a scale
External Body Radiation TherapyOverall Quality of LifeMental Health - 36-months54.2 score on a scale
External Body Radiation TherapyOverall Quality of LifeMental Health - 12-months54.0 score on a scale
External Body Radiation TherapyOverall Quality of LifeMental Health - 48-months54.0 score on a scale
BrachytherapyOverall Quality of LifeMental Health - 12-months55.6 score on a scale
BrachytherapyOverall Quality of LifeMental Health - Baseline54.8 score on a scale
BrachytherapyOverall Quality of LifePhysical Health - 48-months45.8 score on a scale
BrachytherapyOverall Quality of LifePhysical Health - 36-months48.0 score on a scale
BrachytherapyOverall Quality of LifePhysical Health - 24-months47.3 score on a scale
BrachytherapyOverall Quality of LifeMental Health - 24-months55.8 score on a scale
BrachytherapyOverall Quality of LifePhysical Health - 12-months48.7 score on a scale
BrachytherapyOverall Quality of LifePhysical Health - 3-months49.0 score on a scale
BrachytherapyOverall Quality of LifePhysical Health - Baseline50.4 score on a scale
BrachytherapyOverall Quality of LifeMental Health - 3-months53.4 score on a scale
BrachytherapyOverall Quality of LifeMental Health - 36-months55.4 score on a scale
BrachytherapyOverall Quality of LifeMental Health - 48-months56.2 score on a scale
Primary

Prostate Cancer Recurrence

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.

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.

ArmMeasureValue (NUMBER)
Active SurveillanceProstate Cancer Recurrence6.7 percentage of participants
Stereotactic Body Radiation TherapyProstate Cancer Recurrence13.5 percentage of participants
Radical ProstatectomyProstate Cancer Recurrence3.6 percentage of participants
External Body Radiation TherapyProstate Cancer Recurrence7.2 percentage of participants
Secondary

5-year Mortality

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

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.

ArmMeasureValue (NUMBER)
Active Surveillance5-year Mortality9.5 percentage of participants
Stereotactic Body Radiation Therapy5-year Mortality2.9 percentage of participants
Radical Prostatectomy5-year Mortality3.3 percentage of participants
External Body Radiation Therapy5-year Mortality11.3 percentage of participants
Brachytherapy5-year Mortality4.8 percentage of participants
Secondary

Decisional Regret

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

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.

ArmMeasureGroupValue (NUMBER)
Active SurveillanceDecisional Regret12-months9.2 percentage of participants
Active SurveillanceDecisional Regret24-months6.5 percentage of participants
Active SurveillanceDecisional Regret36-months5.6 percentage of participants
Active SurveillanceDecisional Regret48-months5.9 percentage of participants
Stereotactic Body Radiation TherapyDecisional Regret12-months1.1 percentage of participants
Stereotactic Body Radiation TherapyDecisional Regret48-months7.5 percentage of participants
Stereotactic Body Radiation TherapyDecisional Regret24-months7.6 percentage of participants
Stereotactic Body Radiation TherapyDecisional Regret36-months9.5 percentage of participants
Radical ProstatectomyDecisional Regret48-months14.0 percentage of participants
Radical ProstatectomyDecisional Regret24-months18.8 percentage of participants
Radical ProstatectomyDecisional Regret36-months13.9 percentage of participants
Radical ProstatectomyDecisional Regret12-months15.0 percentage of participants
External Body Radiation TherapyDecisional Regret12-months8.3 percentage of participants
External Body Radiation TherapyDecisional Regret24-months8.6 percentage of participants
External Body Radiation TherapyDecisional Regret48-months12.5 percentage of participants
External Body Radiation TherapyDecisional Regret36-months10.1 percentage of participants
BrachytherapyDecisional Regret48-months12.1 percentage of participants
BrachytherapyDecisional Regret36-months9.5 percentage of participants
BrachytherapyDecisional Regret24-months6.5 percentage of participants
BrachytherapyDecisional Regret12-months9.7 percentage of participants
Secondary

Prostate Cancer Anxiety

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

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.

ArmMeasureGroupValue (MEAN)
Active SurveillanceProstate Cancer AnxietyPSA test anxiety - 12-months1.2 score on a scale
Active SurveillanceProstate Cancer AnxietyPSA test anxiety - 48-months1.2 score on a scale
Active SurveillanceProstate Cancer AnxietyProstate cancer anxiety - 24-months1.5 score on a scale
Active SurveillanceProstate Cancer AnxietyProstate cancer anxiety - 48-months1.5 score on a scale
Active SurveillanceProstate Cancer AnxietyPSA test anxiety - 36-months1.2 score on a scale
Active SurveillanceProstate Cancer AnxietyProstate cancer anxiety - 36-months1.4 score on a scale
Active SurveillanceProstate Cancer AnxietyProstate cancer anxiety - 12-months1.6 score on a scale
Active SurveillanceProstate Cancer AnxietyPSA test anxiety - 24-months1.2 score on a scale
Stereotactic Body Radiation TherapyProstate Cancer AnxietyProstate cancer anxiety - 12-months1.4 score on a scale
Stereotactic Body Radiation TherapyProstate Cancer AnxietyProstate cancer anxiety - 24-months1.3 score on a scale
Stereotactic Body Radiation TherapyProstate Cancer AnxietyPSA test anxiety - 24-months1.1 score on a scale
Stereotactic Body Radiation TherapyProstate Cancer AnxietyPSA test anxiety - 12-months1.1 score on a scale
Stereotactic Body Radiation TherapyProstate Cancer AnxietyProstate cancer anxiety - 48-months1.2 score on a scale
Stereotactic Body Radiation TherapyProstate Cancer AnxietyRecurrence anxiety - 12-months1.5 score on a scale
Stereotactic Body Radiation TherapyProstate Cancer AnxietyPSA test anxiety - 48-months1.1 score on a scale
Stereotactic Body Radiation TherapyProstate Cancer AnxietyRecurrence anxiety - 48-months1.5 score on a scale
Stereotactic Body Radiation TherapyProstate Cancer AnxietyRecurrence anxiety - 36-months1.5 score on a scale
Stereotactic Body Radiation TherapyProstate Cancer AnxietyRecurrence anxiety - 24-months1.6 score on a scale
Stereotactic Body Radiation TherapyProstate Cancer AnxietyProstate cancer anxiety - 36-months1.3 score on a scale
Stereotactic Body Radiation TherapyProstate Cancer AnxietyPSA test anxiety - 36-months1.1 score on a scale
Radical ProstatectomyProstate Cancer AnxietyRecurrence anxiety - 48-months1.7 score on a scale
Radical ProstatectomyProstate Cancer AnxietyProstate cancer anxiety - 12-months1.6 score on a scale
Radical ProstatectomyProstate Cancer AnxietyProstate cancer anxiety - 24-months1.5 score on a scale
Radical ProstatectomyProstate Cancer AnxietyProstate cancer anxiety - 36-months1.5 score on a scale
Radical ProstatectomyProstate Cancer AnxietyProstate cancer anxiety - 48-months1.5 score on a scale
Radical ProstatectomyProstate Cancer AnxietyRecurrence anxiety - 12-months1.7 score on a scale
Radical ProstatectomyProstate Cancer AnxietyRecurrence anxiety - 24-months1.7 score on a scale
Radical ProstatectomyProstate Cancer AnxietyRecurrence anxiety - 36-months1.7 score on a scale
Radical ProstatectomyProstate Cancer AnxietyPSA test anxiety - 12-months1.2 score on a scale
Radical ProstatectomyProstate Cancer AnxietyPSA test anxiety - 24-months1.2 score on a scale
Radical ProstatectomyProstate Cancer AnxietyPSA test anxiety - 36-months1.2 score on a scale
Radical ProstatectomyProstate Cancer AnxietyPSA test anxiety - 48-months1.2 score on a scale
External Body Radiation TherapyProstate Cancer AnxietyRecurrence anxiety - 36-months1.9 score on a scale
External Body Radiation TherapyProstate Cancer AnxietyRecurrence anxiety - 12-months1.9 score on a scale
External Body Radiation TherapyProstate Cancer AnxietyRecurrence anxiety - 48-months1.8 score on a scale
External Body Radiation TherapyProstate Cancer AnxietyProstate cancer anxiety - 48-months1.5 score on a scale
External Body Radiation TherapyProstate Cancer AnxietyPSA test anxiety - 12-months1.2 score on a scale
External Body Radiation TherapyProstate Cancer AnxietyProstate cancer anxiety - 36-months1.5 score on a scale
External Body Radiation TherapyProstate Cancer AnxietyPSA test anxiety - 24-months1.2 score on a scale
External Body Radiation TherapyProstate Cancer AnxietyProstate cancer anxiety - 24-months1.5 score on a scale
External Body Radiation TherapyProstate Cancer AnxietyPSA test anxiety - 48-months1.2 score on a scale
External Body Radiation TherapyProstate Cancer AnxietyPSA test anxiety - 36-months1.2 score on a scale
External Body Radiation TherapyProstate Cancer AnxietyRecurrence anxiety - 24-months1.8 score on a scale
External Body Radiation TherapyProstate Cancer AnxietyProstate cancer anxiety - 12-months1.6 score on a scale
BrachytherapyProstate Cancer AnxietyPSA test anxiety - 36-months1.1 score on a scale
BrachytherapyProstate Cancer AnxietyPSA test anxiety - 24-months1.1 score on a scale
BrachytherapyProstate Cancer AnxietyRecurrence anxiety - 36-months1.6 score on a scale
BrachytherapyProstate Cancer AnxietyRecurrence anxiety - 48-months1.6 score on a scale
BrachytherapyProstate Cancer AnxietyProstate cancer anxiety - 48-months1.3 score on a scale
BrachytherapyProstate Cancer AnxietyProstate cancer anxiety - 12-months1.5 score on a scale
BrachytherapyProstate Cancer AnxietyProstate cancer anxiety - 24-months1.4 score on a scale
BrachytherapyProstate Cancer AnxietyRecurrence anxiety - 24-months1.7 score on a scale
BrachytherapyProstate Cancer AnxietyPSA test anxiety - 12-months1.1 score on a scale
BrachytherapyProstate Cancer AnxietyProstate cancer anxiety - 36-months1.3 score on a scale
BrachytherapyProstate Cancer AnxietyRecurrence anxiety - 12-months1.8 score on a scale
BrachytherapyProstate Cancer AnxietyPSA test anxiety - 48-months1.0 score on a scale
Other Pre-specified

Number of Diagnostic Tests and Procedures During Follow-up

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

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.

ArmMeasureGroupValue (MEAN)Dispersion
Active SurveillanceNumber of Diagnostic Tests and Procedures During Follow-upPSA test4.6 tests or proceduresStandard Deviation 2.3
Active SurveillanceNumber of Diagnostic Tests and Procedures During Follow-upTotal tests and procedures6.0 tests or proceduresStandard Deviation 2.7
Active SurveillanceNumber of Diagnostic Tests and Procedures During Follow-upOther tests and procedures1.4 tests or proceduresStandard Deviation 1.3
Stereotactic Body Radiation TherapyNumber of Diagnostic Tests and Procedures During Follow-upOther tests and procedures0.4 tests or proceduresStandard Deviation 0.6
Stereotactic Body Radiation TherapyNumber of Diagnostic Tests and Procedures During Follow-upPSA test4.7 tests or proceduresStandard Deviation 2.8
Stereotactic Body Radiation TherapyNumber of Diagnostic Tests and Procedures During Follow-upTotal tests and procedures5.1 tests or proceduresStandard Deviation 2.9
Radical ProstatectomyNumber of Diagnostic Tests and Procedures During Follow-upOther tests and procedures0.2 tests or proceduresStandard Deviation 0.5
Radical ProstatectomyNumber of Diagnostic Tests and Procedures During Follow-upPSA test5.3 tests or proceduresStandard Deviation 3.2
Radical ProstatectomyNumber of Diagnostic Tests and Procedures During Follow-upTotal tests and procedures5.5 tests or proceduresStandard Deviation 3.3
External Body Radiation TherapyNumber of Diagnostic Tests and Procedures During Follow-upPSA test4.3 tests or proceduresStandard Deviation 2.4
External Body Radiation TherapyNumber of Diagnostic Tests and Procedures During Follow-upTotal tests and procedures4.7 tests or proceduresStandard Deviation 2.4
External Body Radiation TherapyNumber of Diagnostic Tests and Procedures During Follow-upOther tests and procedures0.4 tests or proceduresStandard Deviation 0.6
BrachytherapyNumber of Diagnostic Tests and Procedures During Follow-upOther tests and procedures0.7 tests or proceduresStandard Deviation 0.7
BrachytherapyNumber of Diagnostic Tests and Procedures During Follow-upPSA test4.1 tests or proceduresStandard Deviation 2.4
BrachytherapyNumber of Diagnostic Tests and Procedures During Follow-upTotal tests and procedures4.8 tests or proceduresStandard Deviation 2.5
Other Pre-specified

Number of Physician Visits During Follow-up

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

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.

ArmMeasureGroupValue (MEAN)Dispersion
Active SurveillanceNumber of Physician Visits During Follow-upUrology/Oncology visits5.1 visitsStandard Deviation 3.3
Active SurveillanceNumber of Physician Visits During Follow-upTotal prostate cancer visits6.1 visitsStandard Deviation 3.3
Active SurveillanceNumber of Physician Visits During Follow-upOther specialists visits0.1 visitsStandard Deviation 0.5
Active SurveillanceNumber of Physician Visits During Follow-upTotal physician visits7.6 visitsStandard Deviation 3.8
Active SurveillanceNumber of Physician Visits During Follow-upGeneral practitioner visits1.1 visitsStandard Deviation 1.4
Stereotactic Body Radiation TherapyNumber of Physician Visits During Follow-upUrology/Oncology visits4.1 visitsStandard Deviation 2.6
Stereotactic Body Radiation TherapyNumber of Physician Visits During Follow-upGeneral practitioner visits0.8 visitsStandard Deviation 1.6
Stereotactic Body Radiation TherapyNumber of Physician Visits During Follow-upTotal physician visits6.1 visitsStandard Deviation 3.7
Stereotactic Body Radiation TherapyNumber of Physician Visits During Follow-upOther specialists visits0.1 visitsStandard Deviation 0.6
Stereotactic Body Radiation TherapyNumber of Physician Visits During Follow-upTotal prostate cancer visits4.6 visitsStandard Deviation 3.2
Radical ProstatectomyNumber of Physician Visits During Follow-upGeneral practitioner visits0.6 visitsStandard Deviation 1.4
Radical ProstatectomyNumber of Physician Visits During Follow-upTotal prostate cancer visits4.4 visitsStandard Deviation 3.4
Radical ProstatectomyNumber of Physician Visits During Follow-upTotal physician visits5.6 visitsStandard Deviation 3.9
Radical ProstatectomyNumber of Physician Visits During Follow-upUrology/Oncology visits4.0 visitsStandard Deviation 2.9
Radical ProstatectomyNumber of Physician Visits During Follow-upOther specialists visits0.1 visitsStandard Deviation 0.7
External Body Radiation TherapyNumber of Physician Visits During Follow-upOther specialists visits0.1 visitsStandard Deviation 0.5
External Body Radiation TherapyNumber of Physician Visits During Follow-upTotal prostate cancer visits5.0 visitsStandard Deviation 3.1
External Body Radiation TherapyNumber of Physician Visits During Follow-upUrology/Oncology visits4.4 visitsStandard Deviation 2.5
External Body Radiation TherapyNumber of Physician Visits During Follow-upGeneral practitioner visits1.1 visitsStandard Deviation 1.7
External Body Radiation TherapyNumber of Physician Visits During Follow-upTotal physician visits6.8 visitsStandard Deviation 3.6
BrachytherapyNumber of Physician Visits During Follow-upGeneral practitioner visits0.9 visitsStandard Deviation 1.8
BrachytherapyNumber of Physician Visits During Follow-upUrology/Oncology visits3.6 visitsStandard Deviation 2.2
BrachytherapyNumber of Physician Visits During Follow-upTotal prostate cancer visits4.7 visitsStandard Deviation 2.7
BrachytherapyNumber of Physician Visits During Follow-upOther specialists visits0.0 visitsStandard Deviation 0
BrachytherapyNumber of Physician Visits During Follow-upTotal physician visits6.0 visitsStandard Deviation 3.3

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026