Evaluating frailty and side effects in older men with metastatic prostate cancer receiving hormone therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to understand the factors contributing to frailty and serious side effects in men over 65 who are undergoing androgen deprivation therapy for metastatic prostate cancer. Participants will engage in five study visits over the first year, during which they will provide blood samples, complete surveys, and use a wearable device to monitor their health. Following these visits, there will be a four-year follow-up period where the research team will review participants' medical records and regular doctor visits to gather additional data. The goal is to identify risks associated with hormone therapy in older adults.

Why it matters

Who can join: the full rules

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.

Where it's running

• o University of Chicago Medicine Comprehensive Cancer Center
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Intake
• Email: cancerclinicaltrials@bsd.uchicago.edu
• Phone: 8557028222

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Epidemiology, diagnosis, and treatment patterns of prostate cancer in Algeria

  This project collects medical and treatment information to see how prostate cancer is diagnosed and managed in Algerian men with confirmed disease.

  Recruiting at 21 sites Société Algérienne de Formation et Recherche en Oncologie · Adrar, Algeria and 23 other locations · NCT07484971

• Treatment for advanced prostate cancer using Pluvicto

  This study is testing if a new treatment called Pluvicto can help men with advanced prostate cancer that has spread to their bones feel better and improve their quality of life.

  Recruiting Phase 2 Excel Diagnostics and Nuclear Oncology Center · Houston, Texas · NCT06972628

• 7-day water-only fasting for metastatic prostate cancer

  This study will test whether a 7-day water-only fast (with a ketogenic very low-calorie option) is safe and doable for people with metastatic prostate cancer.

  Recruiting Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, Maryland · NCT06826924

• Treatment for HER2-Positive Metastatic Castration-Resistant Prostate Cancer

  This study is testing a new drug called Enhertu to see if it can help people with a specific type of advanced prostate cancer who haven't had success with other treatments.

  Recruiting Phase 2 Washington D.C. Veterans Affairs Medical Center · Washington D.C., District of Columbia · NCT06610825

• Using a new type of PET scanner for imaging prostate cancer and related conditions

  This study is testing a new type of PET scanner to see if it can better detect early signs of prostate cancer and related conditions in patients.

  Recruiting Jagiellonian University · Krakow · NCT06242119

• Counseling tool for Black men with metastatic prostate cancer

  This study tests a new counseling tool to see if it helps Black men with metastatic prostate cancer understand genetic testing better and if they find it useful.

  Recruiting University of California, San Francisco · San Francisco, California · NCT06171139

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.