Geriatric Assessment and Technology Evaluation in Prostate Cancer

NCT06215508 | Recruiting

• 1 other identifier: IRB23-1569
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

By doing this study, doctors hope to learn more about factors that contribute to frailty (a condition where older adults feel weak, get tired easily, and struggle more with everyday activities) and serious side effects among men over the age of 65 who will receive androgen deprivation therapy (also called "hormone therapy") for prostate cancer that has spread to other parts of their body. Participation in this research will last about 5 years. For the first year, participants will have 5 study visits where they have give blood samples, answer survey questions, and use a wearable device. After study visits are complete, there is a 4-year follow-up period. Research team will check regular doctor visits and look at participants' medical records.

Conditions

Prostate Cancer; Prostate Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Cancer and Aging Research Group (CARG) scores

  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).

  5 years

Secondary Outcomes (1)

• Serious Adverse Events

  5 years

Interventions

Questionnaires OTHER

Questionnaires participants fill out at different study visits

Eligibility Criteria

• Age: 18 Minutes+
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

participants with metastatic prostate cancer over the age of 65

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

o University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Clinical Trials Intake

CONTACT

8557028222; cancerclinicaltrials@bsd.uchicago.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)