Home versus clinic cancer treatment for Black men with advanced or recurrent prostate cancer
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
This Phase II test tries whether giving cancer treatments at home instead of in the clinic is safer and more satisfying for Black men with locally advanced, biochemically recurrent, or metastatic prostate cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | Pembrolizumab, Denosumab, Chemotherapy, Immunotherapy, radiation |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT07073794 on ClinicalTrials.gov |
What this trial studies
This Phase II trial compares delivering standard-of-care intravenous or subcutaneous cancer therapies in the patient's home versus in the clinic for Black or African American men with locally advanced, biochemically recurrent, or metastatic prostate cancer. Home treatments are provided by trained home health providers with remote patient monitoring and Command Center support through the CARE Beyond Walls program, and the protocol tracks safety (grade 3+ adverse events), acute care utilization, and avoidable emergency or hospital visits. The study also collects patient-reported outcomes including satisfaction, function, symptoms, global health/quality of life, reasons for treatment location preference, overall survival, and cost-related measures. Enrollment is at Mayo Clinic in Florida and participants must be receiving an eligible standard-of-care regimen that can be delivered at home.
Who should consider this trial
Good fit: Black or African American men aged 18 or older with locally advanced, high-risk, biochemically recurrent, or metastatic prostate cancer who are starting or receiving an eligible standard-of-care IV or SQ regimen and can receive home health services.
Not a fit: Patients whose treatments cannot be safely administered at home, who have unstable medical conditions requiring frequent in-clinic monitoring, or who cannot accommodate home visits or remote monitoring are unlikely to benefit.
Why it matters
Potential benefit: If successful, home delivery could reduce time away from family, lower acute care visits, improve patient satisfaction and quality of life, and lessen treatment-related burdens.
How similar studies have performed: Home-based administration and remote monitoring models have shown feasibility and improved patient experience in other cancers, but this specific home-delivery program for Black men with advanced prostate cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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 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
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Roxana S. Dronca, MD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.