RECRUITING

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

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Conditions

Prostate Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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..

Official Title

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

Quick Facts

Study Start:2023-03-29
Study Completion:2029-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05840484

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients will have histologic diagnosis of adenocarcinoma of the prostate within 24 months of study entry.
  2. 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. 3. Patients must agree to comply with the surveillance schedule.
  4. 4. Patients must be over 18 years of age
  5. 5. Written informed consent
  6. 6. Patients must be fluent in the English language to participate in the patient report outcome and symptoms monitoring portion of the trial.
  1. 1. Patients are ineligible if they choose not to share their medical data for research purposes.
  2. 2. Prior radiation therapy for treatment of the primary tumor.
  3. 3. Planned concomitant hormonal therapy, chemotherapy, or radiation therapy while on protocol

Contacts and Locations

Study Contact

Christopher Logothetis, MD
CONTACT
713-563-7210
clogothe@mdanderson.org

Principal Investigator

Christopher Logothetis, MD
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Christopher Logothetis, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

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 Registration Dates

Study Start Date2023-03-29
Study Completion Date2029-07-30

Study Record Updates

Study Start Date2023-03-29
Study Completion Date2029-07-30

Terms related to this study

Additional Relevant MeSH Terms

  • Prostate Cancer