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

NCT05840484 | Recruiting

• 2 other identifiers: 2022-0297NCI-2023-03146
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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..

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  through study completion; an average of 1 year.

Study Arms (3)

Cohort-1

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

Other: Active Surveillance

Cohort-2

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

Other: Active Surveillance

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.

Other: Active Surveillance

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.

Cohort-1; Cohort-2; Cohort-3

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

M D Anderson Cancer Center

You may qualify if:

• Patients will have histologic diagnosis of adenocarcinoma of the prostate within 24 months of study entry.
• 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.
• Patients must agree to comply with the surveillance schedule.
• Patients must be over 18 years of age
• Written informed consent
• Patients must be fluent in the English language to participate in the patient report outcome and symptoms monitoring portion of the trial.

You may not qualify if:

• Patients are ineligible if they choose not to share their medical data for research purposes.
• Prior radiation therapy for treatment of the primary tumor.
• Planned concomitant hormonal therapy, chemotherapy, or radiation therapy while on protocol

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Christopher Logothetis, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Logothetis, MD

CONTACT

713-563-7210; clogothe@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 3, 2023
• Study Start: March 29, 2023
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): July 30, 2029
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)