Geriatric Assessment and Technology Evaluation in Prostate Cancer

This observational study aims to understand why some older men (over 65) with prostate cancer that has spread (metastatic) experience frailty (weakness and difficulty with daily activities) and serious side effects when receiving hormone therapy (androgen deprivation therapy). Researchers will gather information about participants' physical, mental, and social health to identify risk factors. You would not receive any new drugs or treatments in this study; you would continue your standard hormone therapy with your doctor. The study will last about 5 years, with 5 visits in the first year.

Study design: This is an observational study with a planned enrollment of 120 men. It is not testing a new drug, but rather gathering information.
What's involved: For the first year, you would have 5 study visits where you will give blood samples, answer survey questions, and use a wearable device. After these visits, there is a 4-year follow-up period where researchers will check your regular doctor visits and medical records.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for 4 years after the initial study visits, with primary outcomes measured at 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Geriatric Assessment and Technology Evaluation in Prostate Cancer

Recruiting

Not specifiedAges 18+Observational

University of Chicago

~120 participants

Updated 2025-06-08 on ClinicalTrials.gov

What's tested:Questionnaires

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Cancer and Aging Research Group (CARG) scores

Measured over 5 years

Conditions

Prostate Cancer

Prostate Cancer Metastatic

Where it's being run

1 sites across 1 states

Illinois1

Who to contact

Clinical Trials Intake

[email protected]

8557028222

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Cancer and Aging Research Group (CARG) scores5 years
To determine if Cancer and Aging Research Group (CARG) scores (≤5 or \>5) correlate with vulnerability as classified by comprehensive geriatric assessment (GA) International Society of Geriatric Oncology 2 (SIOG2) criteria, in older participants with metastatic hormone-sensitive prostate cancer (mHSPC) initiating treatment with androgen receptor signaling inhibitors (ARSI).

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