Comprehensive Monitoring of Men With Prostate Cancer Cared for by "Active Surveillance

Launched by M.D. ANDERSON CANCER CENTER · Apr 24, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on men with prostate cancer who are being monitored through a method called "Active Surveillance." This means that instead of immediate treatment, doctors closely watch the cancer to see if it changes over time. The study aims to see how well electronic tools can help track symptoms and the disease itself, which could lead to better care for patients. Additionally, researchers will collect tissue and health data to better understand how different factors affect cancer outcomes.

To participate in this trial, men must have a confirmed diagnosis of prostate cancer within the last 24 months and meet certain criteria, such as having very low or low-risk cancer, or being at intermediate risk and wanting to opt for Active Surveillance. Eligible participants should be over 18 years old, fluent in English, and willing to share their medical information for research. Those who volunteer will follow a specific monitoring schedule and help researchers learn more about prostate cancer management. It's important to note that patients who have had certain treatments or do not wish to share their medical data are not eligible to join the study.

Gender

MALE

Eligibility criteria

• Inclusion criteria:
• • 1. Patients will have histologic diagnosis of adenocarcinoma of the prostate within 24 months of study entry.
• • 2. Patient must meet at least one of the following clinical indications for AS: National Comprehensive Cancer Network (NCCN) very low risk or low risk prostate cancer meeting consensus guidelines for AS; NCCN intermediate-risk prostate cancer requesting AS (per patient and clinician shared decision making); or have severe medical comorbidities (defined as CCI estimated 10-year survival \< 50% and agreed by treating clinician) with high- or very high-risk localized prostate cancer.
• • 3. Patients must agree to comply with the surveillance schedule.
• • 4. Patients must be over 18 years of age
• • 5. Written informed consent
• • 6. Patients must be fluent in the English language to participate in the patient report outcome and symptoms monitoring portion of the trial.
• Exclusion criteria:
• • 1. Patients are ineligible if they choose not to share their medical data for research purposes.
• • 2. Prior radiation therapy for treatment of the primary tumor.
• • 3. Planned concomitant hormonal therapy, chemotherapy, or radiation therapy while on protocol