Actively Recruiting
A Phase 2 Pragmatic Clinical Trial to Evaluate Administration of Cancer Therapy in the Patients' Homes Versus in Clinic in Black Men With Advanced or Metastatic Prostate Cancer
Led by Mayo Clinic · Updated on 2026-03-25
38
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating cancer treatment given at home versus in a clinic for Black men with locally advanced, biochemically recurrent, or metastatic prostate cancer. This phase II trial aims to compare safety, side effects, patient preference, and satisfaction between these two care settings. The study recognizes that receiving treatment in a familiar home environment may reduce physical, emotional, social, and financial burdens for patients and their families. Participants initially receive standard cancer treatments in a clinic for 6 to 12 weeks. If there is no disease progression or unacceptable toxicity, treatment continues at home for 12 to 24 weeks using the Cancer Connected Access and Remote Expertise Beyond Walls (CCBW) system, which includes home health providers and remote monitoring support. Any remaining treatments are then completed in the clinic. Treatments include intravenous or subcutaneous drugs such as hormone therapies, chemotherapy, immunotherapy, and bone modifying agents. During the study, participants will complete questionnaires about their care experience and preferences. Researchers will monitor safety by tracking serious side effects, emergency visits, hospitalizations, and avoidable acute care events. They will also assess patient-reported symptoms, quality of life, and satisfaction. The study lasts up to 48 weeks, with ongoing evaluations to understand treatment impact and costs in both home and clinic settings.
CONDITIONS
Brief 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, biochemically recurrent, or metastatic prostate cancer
- Currently receiving or planning to start standard-of-care treatment regimen approved or recommended for prostate cancer
- At least one treatment administered by a home health nurse
- Anticipated to continue treatment for at least 18 weeks (chemotherapy or immunotherapy) or 24 weeks (other regimens) following registration
- Residing within the area serviced by the home supplier
- Able and willing to provide written informed consent
- Willing and able to comply with study protocol
- Eastern Cooperative Oncology Group performance status 0, 1, or 2 for qualifying treatments; 0, 1, 2, or 3 for androgen deprivation therapy
- Able to complete questionnaires independently or with 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 (excluding Advanced Care at Home program)
- Severe concurrent illness or co-morbid conditions interfering with safety or assessment
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, recent heart attack (within 6 months), cardiac arrhythmia, wound healing issues, or psychiatric/social issues limiting compliance
- Severe infection within 4 weeks prior to registration, including suspected or confirmed COVID-19
- Anticipation of major surgery during study treatment (radiation allowed)
- Not cleared for home treatment based on social stability screening
- Prior home treatment in another CCBW trial (except withdrawn before home treatment)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 12 weeks in clinic, then 12 to 24 weeks at home
Participants receive standard of care cancer treatment first in the clinic and then at home with support from a home health provider and remote monitoring.
Regular visits for treatment in clinic followed by home treatment visits
Duration - Duration varies based on treatment needs
Participants receive any remaining standard of care cancer treatment in the clinic if needed after home treatment.
Visits in clinic as required to complete treatment
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
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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