Recruiting

Observational Study

Sponsor:

University of Chicago

Code:

NCT06215508

Conditions

Prostate Cancer

Prostate Cancer Metastatic

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Questionnaires

Study Details

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

Study ID

NCT06215508

Start date

Apr, 2026

Status verified date

Jun, 2025

Completion date

Apr, 2031

Anticipated

Primary completion date

Apr, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Interventions

Questionnaires

Questionnaires participants fill out at different study visits

Primary outcome measure

  • Cancer and Aging Research Group (CARG) scores [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Intake

8557028222cancerclinicaltrials@bsd.uchicago.edu

Locations

o University of Chicago Medicine Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Clinical Trials Intake

855-702-8222cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator:

Russell Szmulewitz

More Information

Sponsor

University of Chicago

Last update posted

Jun 8, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-06-08.