Clinical trial NCT06355336: Real World Prostate Cancer Registry
Official title: Patient Reported Data on Prostate Cancer Diagnosis, Management, and Outcome: Real World Prostate Cancer Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Lead sponsor: Cincinnati Cancer Advisors
Sponsor class: NETWORK
First posted: 2024-04-09
Enrollment: 1000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of Ohio, Kentucky or Indiana

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To determine practice patterns for prostate cancer in the region.
timeFrame: 10 years
Secondary outcomes:
measure: To determine progression free survival and overall survival of patients.
timeFrame: 10 years
measure: Prevalence of long term complications of prostate cancer treatment.
timeFrame: 10 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Cancer Advisors
state: Ohio
Study officials:
References:
citation: 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.