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Evaluating In-Home vs. In-Clinic Cancer Therapy for Black Men with Prostate Cancer

This study is looking at whether receiving standard cancer treatment at home is as good as, or better than, getting it in a clinic for Black men with prostate cancer that has come back (biochemically recurrent), spread to nearby areas (locally advanced), or spread to other parts of the body (metastatic). The study will compare how satisfied patients are with their care, their preferences for where they receive treatment, and any serious side effects they experience. The goal is to understand if home-based care can reduce the burdens of clinic visits. This study plans to enroll 38 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 38 adult men. It compares standard cancer treatment given in a clinic to the same treatment given at home.
What's involved
Participants will receive standard cancer treatment, either in a clinic or at home, and complete questionnaires. Safety will be monitored for up to 30 days after the last dose of treatment.
Compensation
Not stated in the trial record.
Follow-up
Patient experience and preferences will be measured for up to 48 weeks. Safety will be monitored for up to 30 days after the last dose of study treatment.

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NCT07073794

Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recurrent and Metastatic Prostate Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Mayo Clinic
~38 participants
Updated 2026-03-25 on ClinicalTrials.gov
What's tested:Cancer Therapeutic ProcedureHealth Care DeliveryQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient rating of overall cancer care experience - CAHPS
Measured over Up to 48 weeks
+4 more outcomes measured

Conditions

Biochemically Recurrent Prostate Carcinoma
Locally Advanced Prostate Carcinoma
Metastatic Prostate Carcinoma
Stage III Prostate Cancer AJCC v8
Stage IV Prostate Cancer AJCC v8

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Roxana S. Dronca, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 18 years
Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) FDA-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g., NCCN, ASCO, ASH, etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines
Black or African American male patients with locally advanced, high risk, biochemical recurrent, or metastatic prostate cancer who are currently receiving or planning to start treatment with one or more of the eligible regimens. Patients may be on any combination of these regimens, provided that at least one is administered by a home health nurse \[co-administration with second generation antiandrogens, poly adenosine diphosphate-ribose polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, or older antiandrogens are allowed but combinations of oral regimens only are not permitted\]
Androgen deprivation therapy (ADT):
Leuprolide intramuscular (IM) or subcutaneous (SQ), 4 or 12 weeks cycle length
Degarelix SQ, 4 weeks cycle length
Chemotherapy: Cabazitaxel IV, 3 weeks cycle length
Immunotherapy: Pembrolizumab IV, 3 weeks cycle length
Bone modifying agent + any of the prostate cancer treatments:
Zoledronic acid IV, 4 or 12 weeks cycle length
Denosumab SQ, 4 or 12 weeks cycle length
Patients who are anticipated to continue the treatment regimen they are currently prescribed for at least 18 weeks following registration (if on chemotherapy or immunotherapy) or 24 weeks following registration (for all other treatment regimens)
Residing within the area serviced by supplier
Provide written informed consent
Willing and able to comply with the study protocol in the investigator's judgement
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 for patients on any qualifying treatment (tx) regimen; ECOG PS 0, 1, 2, or 3 for patients on ADT with or without second generation antiandrogen
Ability to complete questionnaire(s) by themselves or with assistance
Willingness to follow birth control requirements for males of reproductive potential

Exclusion

Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Uncontrolled intercurrent illness including, but not limited to:
Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Myocardial infarction ≤ 6 months
Wound healing disorder
Or psychiatric illness/social situations that would limit compliance with study requirements
Patients with any severe infection within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections should not be enrolled in the trial (in the current situation, this also applies to patients with suspected or confirmed COVID-19 infection)
Anticipation of the need for major surgery during the course of study treatment
Note: Concomitant radiation therapy during the study period is allowed
Not cleared for treatment in home via social stability screening
Patients who received at home treatment through involvement in another CCBW trial
Note: Patients who enrolled in another CCBW trial but had to be withdrawn prior to initiating treatment in the home would still be eligible

What this trial measures

  • Patient rating of overall cancer care experience - CAHPSUp to 48 weeks

    Patient rating of their overall cancer care experience after 12 weeks of at-home cancer treatment will be compared to the same rating after 6 or 12 weeks of in-clinic cancer treatment. Will be assessed using patient ratings from a single item from the Consumer Assessment of Healthcare Providers (CAHPS). Participants will rate "your overall cancer care experience" on a 0 to 10 scale where 0 is the worst experience possible and 10 is the best experience possible.

  • Patient preferences regarding the location of cancer treatment deliveryUp to 48 weeks

    Will be assessed by a single item asking patients to rate their preferred location for cancer treatment delivery on a 1 to 7 scale: 1=strongly prefer in clinic, 2=moderately prefer in clinic, 3=slightly prefer in clinic, 4=no preference, 5=slightly prefer at home, 6=moderately prefer at home, 7=strongly prefer at home.

  • Incidence of grade 3+ adverse events (AEs)Up to 30 days after last dose of study treatment

    Incidence, type, and severity of AEs experienced during the study period will be reported. The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. For individual adverse events and overall, the frequency and proportion of grade 3+ adverse events and grade 3+ adverse events at least possibly related to cancer treatment delivery will be reported for the entire study treatment period and by location of cancer treatment delivery (i.e., in clinic versus at home).

  • Acute care visits, emergency room visits, and hospitalizationsUp to 48 weeks

    The frequency and proportion of patients who experience an acute care visit, emergency room visit, or hospitalization will be reported for the entire study treatment period and by location of cancer treatment delivery (i.e., during in clinic cancer treatment versus at-home cancer treatment).

  • Avoidable acute care visits, emergency room visits and hospitalizationsUp to 48 weeks

    The frequency and proportion of patients who experience an avoidable acute care visit, emergency room visit, or hospitalization while receiving at-home cancer treatment will be reported. Whether an acute care visit, emergency room visit, or hospitalization could have been avoided from changing the location of cancer treatment delivery will be in the opinion of the treating physician.