Real World Prostate Cancer Registry

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06355336
• Lead Sponsor: Cincinnati Cancer Advisors

Brief Summary

Prostate cancer is the most common cancer diagnosed in men in the USA with 268,490 cases diagnosed in 2022 constituting 27% of male cancers and 34,500 deaths (11%) occurred in same year.1 Prostate cancer is a very heterogeneous disease that has different presentations, molecular and pathological features, stages, and disease biology. The treatment options are dependent on the disease stage, its features, and the patient's condition and preferences. The disease outcome also varies significantly due to the previous heterogeneity of the features in addition to other social determinants of health.

Therefore, it is critical to obtain real-world data that reflects the actual patterns of prostate cancer presentation, work up, management, and outcome. Real World Prostate Cancer Registry (RWPCR) aims at compiling real world data from patients presented with prostate cancer in the tristate area. The data collection will be prospective and longitudinal including patients' demographics and disease characteristics, work up, management, and outcome.

Detailed Description

Real World Prostate Cancer Registry (RWPCR) aims at compiling real world data from patients presented with prostate cancer in the tristate area. The data collection will be prospective and longitudinal including patients' demographics and disease characteristics, work up, management, and outcome.

Primary Objectives: Describing the patterns of prostate cancer presentation, management, and outcome in the studied population Identify any impact of the compiled variables on treatment selection, work up and outcome.

Secondary Objectives: Identify any gaps and variations in the delivery of care, challenges and needs to optimize management of the disease and improve patient's outcome.

Improve awareness and facilitate enrollment into clinical trials and research studies.

Data will be collected directly from patients. This data will be collected over 10 years with three years of enrollment and seven years of follow-up. Patients provide e-consent and then get login credentials to complete the e-forms which can be edited and updated by the patient. 6 monthly reminders will be sent to the patients to complete 6 monthly follow-ups

Research staff may contact patients to offer opportunities to participate in clinical trials if eligible. A gift card will be provided to the patient for the initial survey submission. A gift card will also be provided to the patient for each 6 month follow up submission.

Study Timeline

• Study Start: 2024-03-18
• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-04-04
• Study First Posted: 2024-04-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-31
• Primary Completion: 2034-03-18
• Study Completion: 2034-03-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 1000

Inclusion Criteria

All patients with pathologically confirmed primary prostate cancer

Diagnosis since January 1st, 2023

Acceptance to sign the consent form

18 years old or older

Resident of Ohio, Kentucky or Indiana

Exclusion Criteria

Having diagnosis of other cancer except squamous cell cancer of the skin

Refusal to sign a consent form.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine practice patterns for prostate cancer in the region.	10 years	Descriptive analysis of the disease risk groups, disease stages, and type of treatments provided to the patients (radiation, surgery, hormonal therapy).

Secondary Outcome Measures

Name	Time	Method
Prevalence of long term complications of prostate cancer treatment.	10 years	Specifically urine incontinence and erectile dysfunction.
To determine progression free survival and overall survival of patients.	10 years	Percentage of patients participating in clinical trials.

Trial Locations

Locations (1)

Cincinnati Cancer Advisors; 🇺🇸 Cincinnati, Ohio, United States