Cancer of ProstateNCT02564120

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

An observational study of Cancer of Prostate and Cancer of the Prostate, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 35 to 80 years, men only
Conditions the study is for: Cancer of Prostate, Cancer of the Prostate, Prostate Cancer
How many people: 1,556 participants
Where: 1 siteUnited States
Study dates: Jan 2011to 31 Dec 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 80 years
Men only
No healthy volunteers
Adult, Older adult

Study population: Newly-diagnosed, early stage (localized, non-metastatic) prostate cancer patients

Who may be able to join

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.

Who cannot join

Initiation of treatment for prostate cancer prior to completion of baseline interview.
Cognitive impairment.
Hearing problems.
Inability to speak or understand English.

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

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.

Read the 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.

Conditions: Cancer of Prostate, Cancer of the Prostate, Prostate Cancer, Prostatic Cancer
Medical subject headings: Prostatic Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

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."
Measured: 4 years
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.
Measured: 4 years
Prostate Cancer Recurrence
Percentage of patients who had a recurrence of prostate cancer during 5 years of follow-up.
Measured: 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.

Secondary outcomes (3)

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.
Measured: 4 years
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.
Measured: 4 years
5-year Mortality
Percentage of patients who died within 5 years of follow-up.
Measured: From date of diagnosis until date of death or end of follow-up up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201131 Dec 2018

First posted30 Sep 2015 (estimated)
Study startJan 2011
Primary completion31 Dec 2018
Study completion31 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cancer of ProstateStudies of the same condition, open and under way.
More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,556 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02564120
Sponsor's protocol ID: UNC-10-1483
Status last verified: Apr 2020
First submitted: 26 Aug 2015
Last updated: 28 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS)
ClinicalTrials.gov ID: NCT02564120
Acronym / sponsor ID: UNC-10-1483
Conditions: Cancer of Prostate, Cancer of the Prostate, Prostate Cancer, Prostatic Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 1,556 participants (actual)
Lead sponsor: UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute
Study start: Jan 2011
Primary completion: 31 Dec 2018 (actual)
Study completion: 31 Dec 2018 (actual)
First posted: 30 Sep 2015 (estimated)
Results: Posted 7 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 35 to 80 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Newly-diagnosed, early stage (localized, non-metastatic) prostate cancer patients

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (4 listed)

Initiation of treatment for prostate cancer prior to completion of baseline interview.
Cognitive impairment.
Hearing problems.
Inability to speak or understand English.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Cancer-specific Quality of Life
Time frame: 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."
Overall Quality of Life
Time frame: 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.
Prostate Cancer Recurrence
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.
Percentage of patients who had a recurrence of prostate cancer during 5 years of follow-up.

3 secondary outcomes

Prostate Cancer Anxiety
Time frame: 4 years
Decisional Regret
Time frame: 4 years
5-year Mortality
Time frame: From date of diagnosis until date of death or end of follow-up up to 5 years

Results and safety

Results posted to the registry on 7 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NC ProCESS Cohort	1,556	1,110

Primary outcome: Cancer-specific Quality of Life

Time frame: 4 years. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Active Surveillance n = 390	Stereotactic Body Radiation Therapy n = 104	Radical Prostatectomy n = 547	External Body Radiation Therapy n = 247	Brachytherapy n = 125
Sexual Dysfunction - Baseline	44.7 (40.9 to 48.5)	42.0 (34.7 to 49.3)	35.9 (32.8 to 39.0)	52.1 (47.2 to 57.0)	44.9 (38.0 to 51.8)
Sexual Dysfunction - 3-months	44.4 (40.0 to 48.8)	42.1 (34.7 to 49.5)	78.0 (75.5 to 80.5)	65.2 (60.3 to 70.1)	59.0 (52.3 to 65.7)
Sexual Dysfunction - 12-months	48.2 (43.8 to 52.6)	48.2 (40.7 to 55.7)	70.8 (67.9 to 73.7)	62.8 (57.8 to 67.8)	59.3 (52.3 to 66.3)
Sexual Dysfunction - 24-months	55.2 (50.4 to 60.0)	48.8 (40.8 to 56.8)	68.2 (65.0 to 71.4)	64.9 (59.7 to 70.1)	62.3 (54.7 to 69.9)
Sexual Dysfunction - 36-months	50.9 (45.8 to 56.0)	52.3 (43.7 to 60.9)	68.6 (65.1 to 72.1)	64.2 (58.5 to 69.9)	63.7 (55.9 to 71.5)
Sexual Dysfunction - 48-months	56.5 (51.1 to 61.9)	53.9 (44.0 to 63.8)	69.7 (66.0 to 73.4)	66.1 (60.4 to 71.8)	64.0 (55.7 to 72.3)
Urinary Obstruction & Irritation - Baseline	23.4 (22.0 to 24.8)	22.9 (20.4 to 25.4)	23.3 (22.1 to 24.5)	24.2 (22.2 to 26.2)	17.5 (15.7 to 19.3)
Urinary Obstruction & Irritation - 3-months	23.2 (21.7 to 24.7)	24.3 (21.7 to 26.9)	27.0 (25.5 to 28.5)	35.6 (33.0 to 38.2)	40.3 (36.3 to 44.3)

Population analysed: 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.

Primary outcome: Overall Quality of Life

Time frame: 4 years. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Active Surveillance n = 390	Stereotactic Body Radiation Therapy n = 104	Radical Prostatectomy n = 547	External Body Radiation Therapy n = 247	Brachytherapy n = 125
Physical Health - Baseline	47.8 (46.7 to 48.9)	52.1 (50.5 to 53.7)	51.1 (50.3 to 51.9)	47.6 (46.2 to 49.0)	50.4 (48.8 to 52.0)
Physical Health - 3-months	47.6 (46.4 to 48.8)	50.8 (49.0 to 52.6)	49.4 (48.5 to 50.3)	46.4 (45.0 to 47.8)	49.0 (47.4 to 50.6)
Physical Health - 12-months	48.2 (47.1 to 49.3)	50.8 (49.2 to 52.4)	49.8 (48.9 to 50.7)	46.9 (45.5 to 48.3)	48.7 (46.8 to 50.6)
Physical Health - 24-months	46.8 (45.5 to 48.1)	51.2 (49.3 to 53.1)	48.6 (47.6 to 49.6)	46.2 (44.7 to 47.7)	47.3 (45.1 to 49.5)
Physical Health - 36-months	46.8 (45.4 to 48.2)	50.8 (48.8 to 52.8)	49.0 (48.0 to 50.0)	46.6 (44.8 to 48.4)	48.0 (45.7 to 50.3)
Physical Health - 48-months	46.1 (44.7 to 47.5)	50.7 (48.5 to 52.9)	48.4 (47.3 to 49.5)	45.9 (44.2 to 47.6)	45.8 (43.3 to 48.3)
Mental Health - Baseline	54.6 (53.8 to 55.4)	53.2 (51.7 to 54.7)	52.0 (51.2 to 52.8)	52.9 (51.7 to 54.1)	54.8 (53.3 to 56.3)
Mental Health - 3-months	55.0 (54.1 to 55.9)	54.8 (53.4 to 56.2)	52.6 (51.7 to 53.5)	52.9 (51.7 to 54.1)	53.4 (51.8 to 55.0)

Primary outcome: Prostate Cancer Recurrence

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.. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Stereotactic Body Radiation Therapy n = 104	Radical Prostatectomy n = 547	External Body Radiation Therapy n = 247	Brachytherapy n = 125
Value	6.7 (3.3 to 13.2)	13.5 (10.8 to 16.7)	3.6 (1.7 to 6.8)	7.2 (2.7 to 13.4)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NC ProCESS Cohort	0 of 0	0 of 0	58 of 1,110

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer of Prostate and Cancer of the Prostate, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cancer-specific Quality of Life (time frame: 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02564120.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.