NCT05840484 Comprehensive Monitoring of Men With Prostate Cancer Cared for by "Active Surveillance
| NCT ID | NCT05840484 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-03-29 |
| Primary Completion | 2029-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-03-29 with a primary completion date of 2029-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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..
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
Contact & Investigator
Christopher Logothetis, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT05840484 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05840484 currently recruiting?
Yes, NCT05840484 is actively recruiting participants. Contact the research team at clogothe@mdanderson.org for enrollment information.
Where is the NCT05840484 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05840484 clinical trial?
NCT05840484 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Christopher Logothetis, MD at M.D. Anderson Cancer Center. The trial plans to enroll 100 participants.
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