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Trial Title:
Comprehensive Monitoring of Men With Prostate Cancer Cared for by "Active Surveillance
NCT ID:
NCT05840484
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Active Surveillance
Description:
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.
Arm group label:
Cohort-1
Arm group label:
Cohort-2
Arm group label:
Cohort-3
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
Criteria for eligibility:
Study pop:
M D Anderson Cancer Center
Sampling method:
Non-Probability Sample
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Start date:
March 29, 2023
Completion date:
July 30, 2029
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05840484
http://www.mdanderson.org
