Geriatric Assessment and Technology Evaluation in Prostate Cancer

Launched by UNIVERSITY OF CHICAGO · Jan 10, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to understand how certain factors contribute to frailty and serious side effects in older men (65 years and older) who have prostate cancer that has spread to other parts of their body. The study will involve men who have a confirmed diagnosis of prostate cancer and are about to start hormone therapy, which is a common treatment for this condition. To participate, individuals must meet specific criteria, such as having a certain type of prostate cancer and being able to provide informed consent.

If eligible and enrolled in the study, participants can expect to be involved for about 5 years. During the first year, they will attend five study visits where they will provide blood samples, complete surveys, and wear a device that tracks their health. After this initial year, researchers will keep track of their health through regular doctor visits and medical records for the following four years. This study aims to gather important information that could help improve care for older men facing prostate cancer.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Patients must have histologically or cytologically confirmed adenocarcinoma of prostatic origin without neuroendocrine differentiation or signet ring or small-cell histologic features.
• • Patients must be metastatic by having at least one metastatic lesion seen at the time of diagnosis or upon initiation of treatment on bone scan or computed tomography (CT) or magnetic resonance imaging (MRI), or by next-generation molecular imaging (FDG, F-18 sodium fluoride (NaF), C-11 choline, F-18 Fluciclovine, Ga-68 Prostate-specific membrane antigen (PSMA-11) positron emission tomography/computed tomography or magnetic resonance imaging.
• • Age ≥ 65years. positron emission tomography the aforementioned GA tools are only validated in those aged 65 and older.
• • Planned initiation of intensified hormone deprivation (ADT and ARSI)
• • Ability to understand and the willingness to sign a written informed consent document.
• Exclusion Criteria:
• • Participants with previous exposure to ADT/ARSI within 12 months of diagnosis, except those who initiated ADT/ARSI within 12 weeks of enrollment.
• • Participants who had surgical orchiectomy outside of 12 weeks before their metastatic diagnosis.
• • Participants who have had previous chemotherapy for metastatic prostate cancer.
• • Uncontrolled intercurrent illness. "Uncontrolled intercurrent illness" refers to a concurrent medical condition that is not adequately managed or stable at the time of enrollment. This could be any illness, disorder, or medical issue occurring alongside the primary disease being treated or studied, and its lack of control poses additional risk to the patient or complicates the management of the primary condition. For example, in the context of enrolling patients in a clinical trial for a cancer treatment, a patient with uncontrolled diabetes mellitus or hypertension would be considered to have an uncontrolled intercurrent illness as diabetes and hypertension - if poorly managed - can lead complications that could interfere with the patient's ability to safely participate in the trial, potentially confounding the study results or posing additional health risks to the patient.
• • Participants with small-cell carcinoma of the prostate or brain metastasis.
• • Participants who are not fluent in reading/writing English or Spanish.
• • Biologic and Pregnant women are excluded from this study because prostate cancer is a disease of biological males.
• • Participants with implantable cardiac devices.
• • Participants with limb defects precluding smart-watch wear.