Prostate CancerNCT06215508
Geriatric Assessment and Technology Evaluation in Prostate Cancer
An observational study of Prostate Cancer and Prostate Cancer Metastatic, run by University of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 minutes and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Metastatic
- What is being tested?
- Questionnaires
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2026to Apr 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 minutes and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: participants with metastatic prostate cancer over the age of 65
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
o University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Clinical Trials Intake, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Russell Szmulewitz
About this study
Official title: Prostate Cancer Geriatric Assessment and Technology Evaluation (ProsGATE) Study
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.
Read the detailed description
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.
The purpose of this research is to gather information about the physical, mental, and social health of study participants to help the research team identify factors that put older men with prostate cancer at greater risk for developing serious side effects during hormone therapy. This study is for individuals who are over the age of 65 and plan to receive hormone therapy as part of standard treatment for their prostate cancer. Participants will receive androgen deprivation therapy as part of their standard care with their doctor outside of this study. No drugs or treatments will be given in this study. Participants will instead fill out questionnaires, provide blood samples, and wear a smartwatch paired to a mobile application downloaded to the their personal smartphone or a phone/tablet provided by the research team. This application will help the research team collect information about each study participants' levels of function, general health, physical activity, body composition, memory, mood and side effects during hormone therapy. By collecting this information, doctors leading the study ultimately hope to learn new ways to potentially improve treatment options for older men with prostate cancer while lowering their risks for serious side effects.
- Conditions
- Prostate Cancer, Prostate Cancer Metastatic
- Being tested
- Questionnaires
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Questionnaires participants fill out at different study visits
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 years
Secondary outcomes (1)
Serious Adverse Events
To evaluate the relationship between baseline CARG scores in predicting serious adverse events (SAEs) incidence over 12 months in older participants with metastatic hormone-sensitive prostate cancer (mHSPC) patients initiating ARSI therapy.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study startApr 2026 (estimated)
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215508
- Sponsor's protocol ID
- IRB23-1569
- Status last verified
- Jun 2025
- First submitted
- 10 Jan 2024
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Geriatric Assessment and Technology Evaluation (ProsGATE) Study
- ClinicalTrials.gov ID
- NCT06215508
- Acronym / sponsor ID
- IRB23-1569
- Conditions
- Prostate Cancer, Prostate Cancer Metastatic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The purpose of this research is to gather information about the physical, mental, and social health of study participants to help the research team identify factors that put older men with prostate cancer at greater risk for developing serious side effects during hormone therapy. This study is for individuals who are over the age of 65 and plan to receive hormone therapy as part of standard treatment for their prostate cancer. Participants will receive androgen deprivation therapy as part of their standard care with their doctor outside of this study. No drugs or treatments will be given in this study. Participants will instead fill out questionnaires, provide blood samples, and wear a smartwatch paired to a mobile application downloaded to the their personal smartphone or a phone/tablet provided by the research team. This application will help the research team collect information about each study participants' levels of function, general health, physical activity, body composition, memory, mood and side effects during hormone therapy. By collecting this information, doctors leading the study ultimately hope to learn new ways to potentially improve treatment options for older men with prostate cancer while lowering their risks for serious side effects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 minutes and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- participants with metastatic prostate cancer over the age of 65
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuestionnaires participants fill out at different study visits | Other | – |
Primary outcome
Cancer and Aging Research Group (CARG) scores
Time frame: 5 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).
1 secondary outcome
Serious Adverse Events
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Prostate Cancer Metastatic, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Intake (8557028222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer and Aging Research Group (CARG) scores (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.