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

NCT07073794 | Recruiting Phase 2 DMC

• 4 other identifiers: MC240507NCI-2025-0466224-010825W81XWH-24-1-1106
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Patient rating of overall cancer care experience - CAHPS

  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.

  Up to 48 weeks

• Patient preferences regarding the location of cancer treatment delivery

  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.

  Up to 48 weeks

• Incidence of grade 3+ adverse events (AEs)

  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).

  Up to 30 days after last dose of study treatment

• Acute care visits, emergency room visits, and hospitalizations

  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).

  Up to 48 weeks

• Avoidable acute care visits, emergency room visits and hospitalizations

  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.

  Up to 48 weeks

Secondary Outcomes (5)

• Patient-reported function and global health status/quality of life

  Up to 48 weeks

• Patient-reported symptoms as measured by Patient Reported Outcomes (PRO)-CTCAE

  Up to 48 weeks

• Patient-reported symptoms as measured by Functional Assessment of Cancer Therapy General Population 5 (FACT GP5)

  Up to 48 weeks.

• Patient Satisfaction and Feedback Questionnaire

  Up to 48 weeks

• Patient satisfaction - Was It Worth It Questionnaire

  Up to 48 weeks

Study Arms (1)

Treatment (in clinic treatment, in home treatment)

EXPERIMENTAL

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.

Drug: Cancer Therapeutic Procedure; Other: Health Care Delivery; Other: Questionnaire Administration

Interventions

Questionnaire Administration OTHER

Ancillary studies

Treatment (in clinic treatment, in home treatment)

Cancer Therapeutic Procedure DRUG

Given standard of care cancer treatment in clinic

Also known as: anticancer therapy, Cancer Therapy, Cancer Treatment, Malignant Neoplasm Therapy, Malignant Neoplasm Treatment

Treatment (in clinic treatment, in home treatment)

Health Care Delivery OTHER

Receive in home cancer treatment with CCBW

Also known as: Care Delivery, Health Services Delivery, Other, Healthcare Delivery

Treatment (in clinic treatment, in home treatment)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Antineoplastic Protocols; Delivery of Health Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Protocols; Therapeutics; Drug Therapy; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Patient Care Management; Health Services Administration

Study Officials

• Roxana S. Dronca, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: August 27, 2025
• Primary Completion (Estimated): August 27, 2028
• Study Completion (Estimated): August 27, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)