Prostate Cancer - Comparative Outcomes of New Conceptual Paradigms for Treatment (PC-CONCEPT)

This study will use a population-based cohort design to study men with newly diagnosed low- and intermediate-risk prostate cancer at high-volume centers in Southern California (SCa) and New York State (NYS). Complications of contemporary treatments for prostate cancer and quality of life outcomes, such as general health, urinary, sexual, and bowel function, cancer anxiety, and treatment regret will be compared and tracked over the course of this study.

Study Overview

• Status: Enrolling by invitation
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Patient-reported questionnaire

Detailed Description

Prostate cancer remains the most commonly diagnosed, solid organ tumor and the second most common cause of cancer death in U.S. men. Technological advances have enabled new treatment options, such as stereotactic body radiation therapy (SBRT) and partial gland ablation (PGA). Although heavily marketed as more convenient with fewer side effects, there is an absence of high-level, comparative effective research (CER) to discern relative outcomes to traditional therapies such as active surveillance (AS), radical prostatectomy (RP) and intensity modulated radiation therapy (IMRT).

Investigators hypothesize that PGA will be associated with less reduction of urinary and sexual function compared to before treatment than both RP and IMRT. SBRT is hypothesized to be associated with less reduction of urinary and sexual function before treatment compared to RP and IMRT. SBRT is hypothesized to be associated with less reduction in bowel function compared to IMRT. PGA hypothesized to be associated with better overall quality of life at 12 months compared to AS. Investigators hypothesize PGA and SBRT will be associated with fewer adverse events compared to RP and IMRT.

The investigators will conduct a pragmatic, population-based cohort study of men with newly diagnosed low and intermediate risk prostate cancer in Southern California (SCa) and New York State (NYS) Surveillance Epidemiology and End Results (SEER) regions to bridge the evidence gap concerning adverse events and patient reported outcomes. This study will inform multiple stakeholders, who contributed to the study design. Stakeholders include prostate cancer survivors, payers, medical device manufacturers, professional organizations, community and academic prostate cancer experts and the Food and Drug Administration (FDA).

• Study Type: Observational
• Enrollment (Estimated): 3657

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas
  • New York
    • Albany, New York, United States, 11204
      • New York State Department of Health
    • New York, New York, United States, 10065
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects with a diagnosis of prostate cancer who meet the inclusion and exclusion criteria will be eligible for participation in this study.

Description

Inclusion Criteria:

• Pathologically-confirmed clinically localized prostate adenocarcinoma with National Comprehensive Cancer Network (NCCN) low (T1-T2a, Gleason 6, Grade Group 1, PSA <10 ng/mL) or intermediate risk (T2b-T2c or, Gleason 7, Grade Group 2 or 3 or PSA 10-20 ng/mL)72 at one of the selected hospitals in SCa and NYS
• Diagnosis date during the 18 month recruitment window
• Able to read/speak English or Spanish
• Agree to participate by completing the baseline questionnaire

Exclusion Criteria:

• Clinically metastatic disease or high-risk PCa (T3a-T4, Gleason Grade Group 4 or 5 or PSA >20 ng/mL
• Unable to read/speak English or Spanish
• Unwilling or unable to give informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Active Surveillance (AS); Doctor will monitor the patient without directly treating the cancer.	Other: Patient-reported questionnaire; Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.
Stereotactic Body Radiation Therapy (SBRT); Radiation treatment of prostate cancer requiring less than 2 weeks of treatment.	Other: Patient-reported questionnaire; Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.
Intensity-Modulated Radiation Therapy (IMRT); Radiation treatment of prostate cancer requiring more than 2 weeks of treatment.	Other: Patient-reported questionnaire; Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.
Partial Gland Ablation (PGA); Prostate cancer treatment that involves only treating part of the prostate that has cancer. Examples include, but are not limited to, high intensity focused ultrasound (HIFU) and cryotherapy.	Other: Patient-reported questionnaire; Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.
Radical Prostatectomy (RP); Prostate surgery that removes the whole prostate.	Other: Patient-reported questionnaire; Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Adverse Events following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0	All adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade refers to the severity of the adverse event. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each adverse event based on the general guideline: Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living. Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related to adverse event.	8 months
Assessment of Adverse Events following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0	All adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade refers to the severity of the adverse event. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each adverse event based on the general guideline: Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living. Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related to adverse event.	12 months
Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L		Baseline, 8 months, 12 months
Change in Patient-Reported Urinary, Sexual, Bowel, and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26)	The Expanded Prostate Cancer Index Composite (EPIC-26) is a 26-item questionnaire, dichotomized by severity, assessing four domains: urinary, sexual, bowel, and hormonal function. Each domain is scored 0-100, with higher scores indicating greater dysfunction.	Baseline, 8 months, 12 months
Change in Ejaculatory Function as Measured on Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD)	The Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD) is a 4-item questionnaire measuring severity of ejaculatory dysfunction. Degrees of bother, ejaculatory force, ejaculatory volume, and frequency of ejaculation are measured on a scale of 0-5, with higher scores indicating greater dysfunction.	Baseline, 8 months, 12 months
Change in Patient-Reported Anxiety as Measured on Memorial Anxiety Scale for Prostate Cancer (MAX-PC)	The Memorial Anxiety Scale for Prostate Cancer (MAX-PC) is an 18-item questionnaire measuring treatment anxiety. It includes 11 items regarding prostate cancer anxiety, scored 0-33; 3 items regarding PSA testing and anxiety, scored 0-9; and 4 items regarding fear of recurrence, scored 0-12. Scores are combined, with a score of 27 or greater indicating significant anxiety.	Baseline, 8 months, 12 months
Assessment of Cancer Recurrence following Treatment as Measured by Prostate Specific Antigen Levels	Patient PSA levels (ng/mL) will be obtained through medical record review of laboratory (blood) results.	8 months
Assessment of Cancer Recurrence following Treatment as Measured by Prostate Specific Antigen Levels	Patient PSA levels (ng/mL) will be obtained through medical record review of laboratory (blood) results.	12 months
Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry	Clark's Prostate Cancer Health Worry is a 5-item questionnaire measuring treatment regret. All items are scored 0-100, with higher scores indicating greater treatment regret.	8 months
Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry	Clark's Prostate Cancer Health Worry is a 5-item questionnaire measuring treatment regret. All items are scored 0-100, with higher scores indicating greater treatment regret.	12 months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Jim Hu, MD MPH, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 20-08022531 (Other Identifier: Weill Cornell Medicine Institutional Review Board); CER-2019C1-15682 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No