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

Launched by MAYO CLINIC · Jul 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how cancer treatment given at home compares to treatment given in a clinic for Black men with advanced prostate cancer. The types of prostate cancer included are those that have spread nearby, come back after earlier treatment (shown by rising PSA levels), or spread to other parts of the body. Usually, cancer treatments happen in medical centers, which can mean patients spend a lot of time away from their loved ones and familiar surroundings. This study wants to see if giving therapy at home is just as safe and effective, and if it might help reduce stress, improve how patients feel about their care, and make it easier to stick with treatment.

Men who are eligible are Black or African American, at least 18 years old, and have locally advanced, high-risk, recurrent, or metastatic prostate cancer. They must be currently receiving or planning to start certain cancer treatments that can be given by a home health nurse, such as hormone therapy, chemotherapy, or immunotherapy. Participants need to be able to continue their treatment for several months and live in the area served by the home treatment provider. During the study, patients will receive their cancer therapy either at home or in the clinic, and the researchers will check for safety, side effects, and how satisfied patients feel with their care. This trial hopes to show whether home treatment can make cancer care easier and more comfortable without compromising safety for Black men facing advanced prostate cancer.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • 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 Criteria:
• • 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