RecruitingRecruiting
Comprehensive Monitoring of Men With Prostate Cancer Cared for by "Active Surveillance
NCT05840484 · M.D. Anderson Cancer Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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
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
Study design
Enrollment target: 100 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-03-29
Estimated completion: 2029-07-30
Last updated: 2026-02-19
Interventions
Other: Active Surveillance
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 (through study completion; an average of 1 year.)
Sponsor
M.D. Anderson Cancer Center · other
Contacts & investigators
ContactChristopher Logothetis, MD · contact · clogothe@mdanderson.org · 713-563-7210
InvestigatorChristopher Logothetis, MD · principal_investigator, M.D. Anderson Cancer Center
All locations (1)
M D Anderson Cancer CenterRecruiting
Houston, Texas, United States