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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT07073794
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cancer Therapeutic Procedure — DRUG
    Given standard of care cancer treatment in clinic
  • Cancer Therapeutic Procedure — DRUG
    Given standard of care cancer treatment in home
  • Health Care Delivery — OTHER
    Receive in home cancer treatment with CCBW
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Aug 27, 2025
Status verified
Mar 2026
Primary completion
Aug 27, 2028
Completion
Aug 27, 2028

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Patient rating of overall cancer care experience - CAHPS [ Time Frame: Up to 48 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Cancer Center Clinical Trials Team
507-293-6386
Roxana S. Dronca, MD (PRINCIPAL_INVESTIGATOR)

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