Prostate Cancer - Comparative Outcomes of New Conceptual Paradigms for Treatment

Prostate Cancer Clinical Trial

— PC-CONCEPT  

Official title:

Prostate Cancer - Comparative Outcomes of New Conceptual Paradigms for Treatment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04890314
• Other study ID #: 20-08022531
• Secondary ID: CER-2019C1-15682
• Status: Enrolling by invitation
• Start date: May 15, 2021
• Est. completion date: May 30, 2026

Study information

• Verified date: June 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3657
• Est. completion date: May 30, 2026
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Patient-reported questionnaire
Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.

Locations

Country	Name	City	State
United States	New York State Department of Health	Albany	New York
United States	University of Kansas	Kansas City	Kansas
United States	University of Southern California	Los Angeles	California
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L		Baseline, 8 months, 12 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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