Actively Recruiting
Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recurrent and Metastatic Prostate Cancer
Led by Mayo Clinic · Updated on 2026-03-25
38
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial evaluates the impact of cancer therapy in the patients' home compared to in the clinic on safety, side effects, patient preference, and satisfaction in Black men with prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has increasing prostate-specific antigen after treatment (biochemically recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Typically drug-related cancer care is conducted at a medical center which causes patients to have to spend considerable time away from family, friends, and familiar surroundings. This separation may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. Therapy administered to a patient in the patients' residence in the comfort of familiar surrounding using Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) may help reduce psychological and financial distress, increase access to care and improve treatment compliance. Giving cancer therapy in the home compared in the clinic may be safe, tolerable and improve patient satisfaction with overall cancer care in Black men with locally advanced, biochemically recurrent or metastatic prostate cancer.
CONDITIONS
Official Title
Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recurrent and Metastatic Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Black or African American male with locally advanced, high risk, biochemical recurrent, or metastatic prostate cancer
- Currently receiving or planning to start standard-of-care treatment regimen approved or recommended for their disease
- At least one treatment administered by a home health nurse; allowed combinations include androgen deprivation therapy, chemotherapy, immunotherapy, and bone modifying agents
- Expected to continue treatment for at least 18 weeks (chemotherapy or immunotherapy) or 24 weeks (other regimens) after registration
- Residing within the area served by the supplier
- Able and willing to provide written informed consent
- Able to comply with study protocol as judged by investigator
- ECOG performance status 0, 1, or 2 for qualifying treatments; 0 to 3 for androgen deprivation therapy with or without second generation antiandrogen
- Able to complete questionnaires with or without assistance
- Willing to follow birth control requirements if of reproductive potential
You will not qualify if you...
- Receiving any other investigational treatment for the primary cancer
- Currently hospitalized as an inpatient (except for Advanced Care at Home program)
- Severe co-morbid or concurrent illnesses that interfere with safety or assessment
- Uncontrolled illnesses including active infections, symptomatic heart failure, unstable angina, cardiac arrhythmia, recent myocardial infarction (within 6 months), wound healing disorders, or psychiatric/social issues limiting compliance
- Severe infection within 4 weeks prior to registration, including hospitalization for infections or suspected/confirmed COVID-19
- Anticipated need for major surgery during study (radiation therapy allowed)
- Not cleared for home treatment due to social stability
- Previously received home treatment through participation in another CCBW trial (except if withdrawn before home treatment began)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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