Prostate AdenocarcinomaNCT06470750
Feasibility of Patient-Centered Home Care (PCHC) to Reduce Disparities in High-Risk Black Men (BM) With Prostate Cancer (CaP)
An observational study of Prostate Adenocarcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This study evaluates the possibility of patient-centered home care as a new model of cancer care to reduce disparities and improve health related quality of life and patient-reported outcomes in Black patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2024to 29 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals identifying as Black and male who are familiar with the landscape of medical care and cancer, as well as individuals identifying as an African American/Black man with prostate adenocarcinoma requiring prostate cancer therapy and individuals identifying as an African American/Black man with prostate adenocarcinoma requiring active standard hormone-based therapies, antibone resorptive agents, oral anticancer treatments, or intravenous chemotherapy and receiving part of supportive care/symptom management and/or anti-cancer therapy in the home as part of the Advanced Care at Home Program
Who may be able to join
- GROUP 1 FOCUS GROUPS:
- Individuals identifying as Black and male who are familiar with the landscape of medical care and cancer
- GROUP 1 SURVEYS:
- Are 18 years of age or older
- Have histologic evidence of prostate adenocarcinoma
- Are requiring, have required, or will require prostate cancer treatment
Show all 19Show fewer
- Have an understanding of the protocol and its requirements
- Are willing to fill in a questionnaire and participate in a focused interview
- Are able and willing to sign an informed consent
- GROUP 1 INTERVIEWS:
- Enrollment in the survey phase of the protocol
- GROUP 2:
- Are 18 years of age or older
- Are Black men or other discounted patients (older adults, individuals residing in rural or remote areas, and those facing transportation challenges)
- Have histologic evidence of prostate adenocarcinoma
- Are requiring active standard hormone-based therapies (degarelix or leuprolide), antibone resorptive agents (zoledronic acid or denosumab), oral anticancer treatments (abiraterone or second-generation androgen receptor blockers) or intravenous chemotherapy (docetaxel)
- Are receiving part of supportive care/symptom management and/or anti-cancer therapy in the home as part of Cancer Care Beyond Walls (CCBW)
- Have an understanding of the protocol and its requirements
- Are able and willing to sign informed consent
Who cannot join
- GROUP 1 FOCUS GROUPS:
- Individuals who do not identify as Black or male or who have had no extensive interaction with the healthcare system
- GROUP 1 SURVEYS:
- Do not identify as Black men
- Have not been diagnosed with prostate cancer
- GROUP 1 INTERVIEWS:
Show all 11Show fewer
- Not enrolled in the survey phase of the protocol
- GROUP 2:
- Do not identify as Black men or other discounted patients (older adults, individuals residing in rural or remote areas, and those facing transportation challenges)
- Have not been diagnosed with histologic evidence of prostate adenocarcinoma
- Are not requiring active standard anti-cancer therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
About this study
Official title: Feasibility of Patient-Centered Home Care (PCHC) to Reduce Disparities in High-Risk Black Men (BM) With Advanced Prostate Cancer (CaP)
This study evaluates the possibility of patient-centered home care as a new model of cancer care to reduce disparities and improve health related quality of life and patient-reported outcomes in Black patients with prostate cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate a highly innovative project evaluating the feasibility of patient-centered home care PCHC as a new model of cancer care to reduce disparities and improve health related QoL (HRQoL) and patient reported-outcomes (PROs) in Black patients with advanced prostate cancer (CaP). (Phase I) II. Establish patient-centeredness by exploring patients' choice relative to the place of CaP treatment for certain aspects of therapy as well as end-of-life care.
III. Establish the acceptance and impact of PCHC on PROs and HRQoL in BM with advanced CaP.
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.
GROUP 1: Participants take part in a focus group or complete questionnaires and may take part in an interview on study.
GROUP 2: Participants complete questionnaires throughout the study.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Non-Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational group 1 | Participants take part in a focus group or complete questionnaires and may take part in an interview on study. Receives: Other: Non-Interventional Study | |
| Observational group 2 | Participants complete questionnaires throughout the study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Patient-centered Home Care (PCHC)
Participants will be asked to fill in a brief questionnaire regarding: patient preference for location of therapy (at the infusion center or in the home); perceived difficulties (isolation, less contact with hospital staff and other patients, feeling less secure with less back-up outside the hospital setting, the possibility of equipment malfunctions and complications in the home setting); and advantages (less travelling to specialized medical facilities, reduced risk of hospital acquired infections or blood clots, the ability to receive treatment in the comfort and security of the home, less disruption to family life, increased feeling of control over treatment and illness). Feasibility will be assessed based on responses to the questionnaire.
Measured: Up to 6 months
Secondary outcomes (2)
Time to emergency room visit
Time to first emergency room visit will be recorded.
Measured: Up to 6 months
Time to hospital visit
The time to first hospitalization will be recorded.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start25 Jul 2024
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Roxana S. Dronca, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470750
- Sponsor's protocol ID
- CaP PCHC
- Other IDs
- W81XWH2210969, W81XWH2210968, NCI-2024-04792, 22-004375, CaP PCHC
- Status last verified
- Sep 2026
- First submitted
- 18 Jun 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Patient-Centered Home Care (PCHC) to Reduce Disparities in High-Risk Black Men (BM) With Advanced Prostate Cancer (CaP)
- ClinicalTrials.gov ID
- NCT06470750
- Acronym / sponsor ID
- CaP PCHC
- Conditions
- Prostate Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 24 Jun 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.
This study evaluates the possibility of patient-centered home care as a new model of cancer care to reduce disparities and improve health related quality of life and patient-reported outcomes in Black patients with prostate cancer.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate a highly innovative project evaluating the feasibility of patient-centered home care PCHC as a new model of cancer care to reduce disparities and improve health related QoL (HRQoL) and patient reported-outcomes (PROs) in Black patients with advanced prostate cancer (CaP). (Phase I) II. Establish patient-centeredness by exploring patients' choice relative to the place of CaP treatment for certain aspects of therapy as well as end-of-life care.
III. Establish the acceptance and impact of PCHC on PROs and HRQoL in BM with advanced CaP.
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.
GROUP 1: Participants take part in a focus group or complete questionnaires and may take part in an interview on study.
GROUP 2: Participants complete questionnaires throughout the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational group 1 | – | Other: Non-Interventional StudyParticipants take part in a focus group or complete questionnaires and may take part in an interview on study. |
| Observational group 2 | – | Other: Non-Interventional StudyParticipants complete questionnaires throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals identifying as Black and male who are familiar with the landscape of medical care and cancer, as well as individuals identifying as an African American/Black man with prostate adenocarcinoma requiring prostate cancer therapy and individuals identifying as an African American/Black man with prostate adenocarcinoma requiring active standard hormone-based therapies, antibone resorptive agents, oral anticancer treatments, or intravenous chemotherapy and receiving part of supportive care/symptom management and/or anti-cancer therapy in the home as part of the Advanced Care at Home Program
Key inclusion criteria (19 listed)
- GROUP 1 FOCUS GROUPS:
- GROUP 1 SURVEYS:
- GROUP 1 INTERVIEWS:
- GROUP 2:
Key exclusion criteria (11 listed)
- GROUP 1 FOCUS GROUPS:
- GROUP 1 SURVEYS:
- GROUP 1 INTERVIEWS:
- GROUP 2:
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 |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational group 1, Observational group 2 |
Primary outcome
Feasibility of Patient-centered Home Care (PCHC)
Time frame: Up to 6 months
Participants will be asked to fill in a brief questionnaire regarding: patient preference for location of therapy (at the infusion center or in the home); perceived difficulties (isolation, less contact with hospital staff and other patients, feeling less secure with less back-up outside the hospital setting, the possibility of equipment malfunctions and complications in the home setting); and advantages (less travelling to specialized medical facilities, reduced risk of hospital acquired infections or blood clots, the ability to receive treatment in the comfort and security of the home, less disruption to family life, increased feeling of control over treatment and illness). Feasibility will be assessed based on responses to the questionnaire.
2 secondary outcomes
Time to emergency room visit
Time frame: Up to 6 months
Time to hospital visit
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Prostate Adenocarcinoma
RecruitingPhase 2
Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance
Adenocarcinoma, Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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. This study is not recruiting at the moment.
Roxana S. Dronca, MD principal investigator
Mayo Clinic
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 Adenocarcinoma, run by Mayo Clinic 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 19 inclusion and 11 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: finished, as of the sponsor's last update on 3 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Patient-centered Home Care (PCHC) (time frame: Up to 6 months). 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 3 Sep 2026.