Recruiting
Phase 2

Cancer Therapy

Sponsor:

Mayo Clinic

Code:

NCT07073794

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+

Healthy Volunteers: Not accepted

Interventions

Cancer Therapeutic Procedure

Cancer Therapeutic Procedure

Health Care Delivery

Questionnaire Administration

Study Details

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

Study ID

NCT07073794

Start date

Aug 27, 2025

Status verified date

Mar, 2026

Completion date

Aug 27, 2028

Anticipated

Primary completion date

Aug 27, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

38 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Cancer Therapeutic Procedure

Given standard of care cancer treatment in clinic

Cancer Therapeutic Procedure

Given standard of care cancer treatment in home

Health Care Delivery

Receive in home cancer treatment with CCBW

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Patient rating of overall cancer care experience - CAHPS [ Time Frame: Up to 48 weeks ]
  • Patient preferences regarding the location of cancer treatment delivery [ Time Frame: Up to 48 weeks ]
  • Incidence of grade 3+ adverse events (AEs) [ Time Frame: Up to 30 days after last dose of study treatment ]
  • Acute care visits, emergency room visits, and hospitalizations [ Time Frame: Up to 48 weeks ]
  • Avoidable acute care visits, emergency room visits and hospitalizations [ Time Frame: Up to 48 weeks ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Cancer Center Clinical Trials Team

507-293-6386

Principal Investigator:

Roxana S. Dronca, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-25.