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

NCT ID: NCT05840484

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-29
• Study Completion Date: 2029-07-30

Brief 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

Conditions

Prostate Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort-1

Participants with localized very low- or low-risk prostate cancer meeting consensus criteria for active surveillance

Active Surveillance

Intervention Type: 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.

Cohort-2

Participants with NCCN intermediate-risk localized prostate cancer requesting active surveillance (per patient and clinician shared decision making);

Active Surveillance

Intervention Type: 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.

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.

Active Surveillance

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Logothetis, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christopher Logothetis, MD

Role: CONTACT

clogothe@mdanderson.org

713-563-7210

Facility Contacts

Christopher Logothetis, MD

Role: primary

clogothe@mdanderson.org

713-563-7210

Related Links

http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

NCI-2023-03146

Identifier Type: OTHER

Identifier Source: secondary_id

2022-0297

Identifier Type: -

Identifier Source: org_study_id