Evaluating frailty and side effects in older men with metastatic prostate cancer receiving hormone therapy
Prostate Cancer Geriatric Assessment and Technology Evaluation (ProsGATE) Study
This study is trying to find out what makes older men with advanced prostate cancer feel weaker and have side effects while they are on hormone therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Minutes and up |
| Sex | Male |
| Sponsor | University of Chicago Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06215508 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 65 and older with confirmed metastatic prostate cancer who are planning to receive hormone therapy.
Not a fit: Patients who are younger than 65 or those without metastatic prostate cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and care strategies for older men with prostate cancer, potentially reducing frailty and serious side effects during treatment.
How similar studies have performed: While there have been studies focusing on frailty in older cancer patients, this specific approach to evaluating frailty in the context of hormone therapy for metastatic prostate cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chicago, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.