Comprehensive monitoring for men on active surveillance for prostate cancer

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

This project will test whether electronic symptom and disease tracking plus a linked tissue and data resource can help guide care for men on active surveillance for prostate cancer.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05840484 on ClinicalTrials.gov

What this trial studies

This observational study will follow men with prostate adenocarcinoma who meet consensus criteria for active surveillance, including very low/low-risk, some intermediate-risk who choose surveillance, or patients with severe comorbidities who opt for surveillance. Participants will use electronically facilitated symptom and disease monitoring to prompt clinical review and possible therapeutic changes as needed. The protocol also builds a tissue and data biorepository to support discovery research on germline and somatic alterations and their relationship to cancer-specific and overall outcomes. Data will be collected at M.D. Anderson Cancer Center with patient-reported outcomes captured electronically.

Who should consider this trial

Good fit: Men over 18 with histologically confirmed prostate adenocarcinoma within 24 months who meet NCCN very low/low-risk criteria for active surveillance, or who choose surveillance despite intermediate risk, or who have severe comorbidities and opt for surveillance, and who consent and are fluent in English.

Not a fit: Patients who need immediate definitive treatment, who decline data sharing, who cannot comply with the surveillance schedule, or who are not fluent in English for the electronic patient-reported portion are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the approach could detect progression earlier and support more personalized decisions about when to move from surveillance to treatment.

How similar studies have performed: Prior research has established the safety and utility of active surveillance and some pilot work has used remote symptom monitoring, but combining electronic monitoring with a linked tissue/genomic resource is relatively novel.

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

Where this trial is running

Houston, Texas

• M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Christopher Logothetis, MD — M.D. Anderson Cancer Center
• Study coordinator: Christopher Logothetis, MD

Conditions Prostate Cancer