Comprehensive Monitoring of Men With Prostate Cancer Cared for by "Active Surveillance
M.D. Anderson Cancer Center
100 participants
Mar 29, 2023
OBSERVATIONAL
Conditions
Summary
Prostate cancer is the most commonly diagnosed cancer in men. However, there is a wide range in prognosis determined by a host of factors. This study will evaluate the feasibility of guiding therapeutic intervention electronically facilitated symptom and disease monitoring in patients being followed on Active Surveillance. Additionally, we will develop a tissue and data resource to support discovery and hypothesis generation to evaluate germline and/or somatic alterations in relation to cancer-specific and overall outcomes..
Eligibility
Inclusion Criteria6
- Patients will have histologic diagnosis of adenocarcinoma of the prostate within 24 months of study entry.
- 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.
- Patients must agree to comply with the surveillance schedule.
- Patients must be over 18 years of age
- Written informed consent
- Patients must be fluent in the English language to participate in the patient report outcome and symptoms monitoring portion of the trial.
Exclusion Criteria3
- Patients are ineligible if they choose not to share their medical data for research purposes.
- Prior radiation therapy for treatment of the primary tumor.
- Planned concomitant hormonal therapy, chemotherapy, or radiation therapy while on protocol
Interventions
Participants will be asked to complete questionnaires, have physical and rectal examinations, have prostate biopsies, and have imaging scans (such as MRIs). These visits will be done between every 6 months and every 2-3 years, depending on the test/procedure.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05840484