Comprehensive Monitoring of Men With Prostate Cancer Cared for by "Active Surveillance
Recruiting · NCT05840484 · Observational (researchers observe without assigning treatment) · Lead sponsor: M.D. Anderson Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
Active Surveillance
What this trial is about
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..
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed across 1 US state.
- M D Anderson Cancer Center - Houston, Texas, United States