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

March 18, 2024 updated by: M.D. Anderson Cancer Center
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..

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Christopher Logothetis, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

M D Anderson Cancer Center

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christopher Logothetis, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2023

Primary Completion (Estimated)

July 30, 2029

Study Completion (Estimated)

July 30, 2029

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

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

No

Studies a U.S. FDA-regulated device product

No

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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