A Study Of Cancer Therapy In The Patients’ Homes Versus In Clinic In Black Men With Advanced Or Metastatic Prostate Cancer

Overview

About this study

In this pragmatic trial, we propose to test a care delivery model where black patients with advanced or metastatic prostate cancer will be offered to receive a part of their treatment within their home environment.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥18 years.

  • 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 listed below. 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 anti-androgens, PARP inhibitors, oral GnRh antagonists, estrogens, or older antiandrogens are allowed but combinations of oral regimens only are not permitted).

  • 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.

  • ECOG Performance Status (PS) 0, 1, or 2 for patients on any qualifying tx regimen; ECOG PS 0, 1, 2, or 3 for patients on ADT with or without second generation antiandrogen (Appendix 1: ECOG Performance Status).

  • Ability to complete questionnaire(s) by themselves or with assistance.

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. 

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/06/2025. Questions regarding updates should be directed to the study team contact.


Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Roxana Dronca, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20586380

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