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

NCT ID: NCT07073794

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-27
• Study Completion Date: 2028-08-27

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To establish patient-centeredness by comparing patient ratings of their overall cancer care experience in the clinic versus in the home.

II. To establish patient-centeredness by evaluating patient preferences regarding the location of cancer treatment delivery.

SAFETY OBJECTIVES:

I. To assess the safety of home administered intravenous (IV)/subcutaneous (SQ) drug treatment by a home health provider with remote patient monitoring and Command Center support as measured by the incidence of grade 3+ adverse events at least possibly related to cancer treatment delivery.

II. To describe the incidence of acute care visits, emergency room visits, and hospitalizations during the entire study treatment period and by location of cancer treatment delivery (i.e., during in-clinic cancer treatment versus at-home cancer treatment).

III. To describe the incidence of avoidable (in the opinion of the treating physician) acute care visits, emergency room visits, and hospitalizations during at-home cancer treatment.

SECONDARY OBJECTIVE:

I. To evaluate the impact of home cancer treatment delivery on patient-reported function and global health/quality of life, patient-reported symptoms, satisfaction, and clinical outcomes.

EXPLORATORY OBJECTIVES:

I. To summarize patient perceptions and reasons for patient preferences regarding the location of cancer treatment delivery.

II. To describe overall survival. III. To assess the cost outcomes related to patient treatment in the clinic or in the home.

OUTLINE:

Patients receive standard of care treatment in the clinic for 6-12 weeks then receive treatment in the home with CCBW for 12-24 weeks in the absence of disease progression or unacceptable toxicity. Patients receive any remaining treatment in the clinic.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (in clinic treatment, in home treatment)

Patients receive standard of care treatment in the clinic for 6-12 weeks then receive treatment in the home with CCBW for 12-24 weeks in the absence of disease progression or unacceptable toxicity. Patients receive any remaining treatment in the clinic.

Group Type: EXPERIMENTAL

Cancer Therapeutic Procedure

Intervention Type: DRUG

Given standard of care cancer treatment in clinic

Cancer Therapeutic Procedure

Intervention Type: DRUG

Given standard of care cancer treatment in home

Health Care Delivery

Intervention Type: OTHER

Receive in home cancer treatment with CCBW

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Cancer Therapeutic Procedure

Given standard of care cancer treatment in clinic

Intervention Type: DRUG

Cancer Therapeutic Procedure

Given standard of care cancer treatment in home

Intervention Type: DRUG

Health Care Delivery

Receive in home cancer treatment with CCBW

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

anticancer therapy; Cancer Therapy; Cancer Treatment; Malignant Neoplasm Therapy; Malignant Neoplasm Treatment; anticancer therapy; Cancer Therapy; Cancer Treatment; Malignant Neoplasm Therapy; Malignant Neoplasm Treatment; Care Delivery; Health Services Delivery, Other; Healthcare Delivery

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Congressionally Directed Medical Research Programs

FED

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roxana S. Dronca, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Trials Referral Office

Role: CONTACT

mayocliniccancerstudies@mayo.edu

855-776-0015

Facility Contacts

Clinical Trials Referral Office

Role: primary

mayocliniccancerstudies@mayo.edu

855-776-0015

Cancer Center Clinical Trials Team

Role: backup

507-293-6386

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2025-04662

Identifier Type: REGISTRY

Identifier Source: secondary_id

24-010825

Identifier Type: OTHER

Identifier Source: secondary_id

MC240507

Identifier Type: OTHER

Identifier Source: secondary_id

W81XWH-24-1-1106

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MC240507

Identifier Type: -

Identifier Source: org_study_id