Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05840484

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Active Surveillance

Study Details

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

Study ID

NCT05840484

Start date

Mar 29, 2023

Status verified date

Aug, 2026

Completion date

Jul 30, 2029

Anticipated

Primary completion date

Jul 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort-1

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

Cohort-2

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

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.

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.

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 and Locations

Central contacts

Christopher Logothetis, MD

713-563-7210clogothe@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Christopher Logothetis, MD

713-563-7210clogothe@mdanderson.org

Principal Investigator:

Christopher Logothetis, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-10.