Prostate Cancer Clinical Trial

Prostate Cancer – Comparative Outcomes of New Conceptual Paradigms for Treatment

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.

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Full 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).

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Eligibility Criteria

Inclusion Criteria:

Pathologically-confirmed clinically localized prostate adenocarcinoma with National Comprehensive Cancer Network (NCCN) low (T1-T2a, Gleason 6, Grade Group 1, PSA <10 ngmL) or intermediate risk (T2b-T2c or, Gleason 7, Grade Group 2 3 PSA 10-20mL)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 is for people with:

Prostate Cancer

Estimated Enrollment:

3657

Study ID:

NCT04890314

Recruitment Status:

Enrolling by invitation

Sponsor:

Weill Medical College of Cornell University

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There are 4 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

3657

Study ID:

NCT04890314

Recruitment Status:

Enrolling by invitation

Sponsor:


Weill Medical College of Cornell University

How clear is this clinincal trial information?

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