Prostate Cancer - Comparative Outcomes of New Conceptual Paradigms for Treatment

NCT ID: NCT04890314

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1953 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2024-04-30

Brief 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.

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).

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Active Surveillance (AS)

Doctor will monitor the patient without directly treating the cancer.

Patient-reported questionnaire

Intervention Type: OTHER

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.

Patient-reported questionnaire

Intervention Type: OTHER

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.

Patient-reported questionnaire

Intervention Type: OTHER

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.

Patient-reported questionnaire

Intervention Type: OTHER

Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.

Radical Prostatectomy (RP)

Prostate surgery that removes the whole prostate.

Patient-reported questionnaire

Intervention Type: OTHER

Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.

Interventions

Patient-reported questionnaire

Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.

Intervention Type: OTHER

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jim Hu, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

University of Southern California

Los Angeles, California, United States

University of Kansas

Kansas City, Kansas, United States

New York State Department of Health

Albany, New York, United States

Weill Cornell Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CER-2019C1-15682

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20-08022531

Identifier Type: OTHER

Identifier Source: secondary_id

20-08022531

Identifier Type: -

Identifier Source: org_study_id