Comprehensive Monitoring of Men With Prostate Cancer Cared for by "Active Surveillance
Overview
- Phase
- Not Applicable
- Intervention
- Active Surveillance
- Conditions
- Prostate Cancer
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- To estimate the 5-year disease progression rate of patients with low or very low-risk prostate cancer who choose to undergo active surveillance with remote monitoring
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
Brief 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..
Detailed Description
Primary objectives: 1\. Monitor cancer-specific outcomes of men who meet consensus criteria for active surveillance under one of three categories: 1) low or very low-risk prostate cancer, 2) intermediate risk with patient consent, or 3) severe medical comorbidities and high-risk localized prostate cancer or patient desire, despite recommendation Secondary objectives: 1. Screen for a relationship between cancer-specific and clinical outcomes related to selected comorbidities. 2. Determine the feasibility of electronically facilitated symptoms and disease monitoring to guide therapeutic intervention and prompt therapeutic course correction. 3. Develop a tissue and data resource to support discovery and hypothesis generation focused on germline alterations, somatic alterations, and/or the interaction between the two in determining cancer-specific and overall outcomes
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Cohort-1
Participants with localized very low- or low-risk prostate cancer meeting consensus criteria for active surveillance
Intervention: Active Surveillance
Cohort-2
Participants with NCCN intermediate-risk localized prostate cancer requesting active surveillance (per patient and clinician shared decision making);
Intervention: Active Surveillance
Cohort-3
Participants with severe medical comorbidities (defined as CCI estimated 10-year survival \< 50% and agreed by treating clinician) and high- or very high-risk group localized prostate cancer. Clinical trial investigators and staff will make every effort to integrate study visits with the subjects' clinic visits during participation.
Intervention: Active Surveillance
Outcomes
Primary Outcomes
To estimate the 5-year disease progression rate of patients with low or very low-risk prostate cancer who choose to undergo active surveillance with remote monitoring
Time Frame: through study completion; an average of 1 year.