Comprehensive Monitoring of Men With Prostate Cancer Cared for by "Active Surveillance

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05840484
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Active Surveillance — OTHER
    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.

Study Details

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..

Key Dates

Start date
Mar 29, 2023
Status verified
Feb 2026
Primary completion
Jul 30, 2029
Completion
Jul 30, 2029

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Cohort-1
    Participants with localized very low- or low-risk prostate cancer meeting consensus criteria for active surveillance
  • Arm: Cohort-2
    Participants with NCCN intermediate-risk localized prostate cancer requesting active surveillance (per patient and clinician shared decision making);
  • Arm: 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.

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Christopher Logothetis, MD
[email protected]
713-563-7210
Christopher Logothetis, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
M D Anderson Cancer Center· Houston, TX

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