- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05840484
Comprehensive Monitoring of Men With Prostate Cancer Cared for by "Active Surveillance
Study Overview
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:
- Screen for a relationship between cancer-specific and clinical outcomes related to selected comorbidities.
- Determine the feasibility of electronically facilitated symptoms and disease monitoring to guide therapeutic intervention and prompt therapeutic course correction.
- 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
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Christopher Logothetis, MD
- Phone Number: 713-563-7210
- Email: clogothe@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Christopher Logothetis, MD
- Phone Number: 713-563-7210
- Email: clogothe@mdanderson.org
-
Principal Investigator:
- Christopher Logothetis, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cohort-1
Participants with localized very low- or low-risk prostate cancer meeting consensus criteria for active surveillance
|
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.
|
Cohort-2
Participants with NCCN intermediate-risk localized prostate cancer requesting active surveillance (per patient and clinician shared decision making);
|
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.
|
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
through study completion; an average of 1 year.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher Logothetis, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-0297
- NCI-2023-03146 (Other Identifier: NCI-CTRP Clinical Trials Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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