Real World Prostate Cancer Registry

Prostate Cancer Clinical Trial

— RWPCR  

Official title:

Patient Reported Data on Prostate Cancer Diagnosis, Management, and Outcome: Real World Prostate Cancer Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06355336
• Other study ID #: CCA/IRN-24-001
• Status: Recruiting
• Start date: March 18, 2024
• Est. completion date: March 18, 2034

Study information

• Verified date: April 2024
• Source: Cincinnati Cancer Advisors
• Contact: Abdul Jazieh, MD, MPH
• Phone: 5137312273
• Email: a.jazieh[@]cincinnaticanceradvisors.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 18, 2034
• Est. primary completion date: March 18, 2034
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All patients with pathologically confirmed primary prostate cancer

Diagnosis within 12 months of the study enrollment.

Acceptance to sign the consent form.

18 years old or older

Resident in Tristate area including Greater Cincinnati Area, Northern Kentucky, and Southeast Indiana

Exclusion Criteria:

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

Refusal to sign a consent form.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	Cincinnati Cancer Advisors	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Cincinnati Cancer Advisors

Country where clinical trial is conducted

United States, 

References & Publications (1)

Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine practice patterns for prostate cancer in the region.	Descriptive analysis of the disease risk groups, disease stages, and type of treatments provided to the patients (radiation, surgery, hormonal therapy).	10 years
Secondary	To determine progression free survival and overall survival of patients.	Percentage of patients participating in clinical trials.	10 years
Secondary	Prevalence of long term complications of prostate cancer treatment.	Specifically urine incontinence and erectile dysfunction.	10 years