Phase
Condition
Prostate Cancer
Prostate Cancer, Early, Recurrent
Urologic Cancer
Treatment
Cancer Therapeutic Procedure
Questionnaire Administration
Health Care Delivery
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years
Participant must be receiving a standard-of-care treatment regimen listed in thisprotocol that is being used in accordance with standard medical practice.Specifically, it must be either a) FDA-approved for the participant's diseaseindication, 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 orplanning to start treatment with one or more of the eligible regimens. Patients maybe on any combination of these regimens, provided that at least one is administeredby a home health nurse [co-administration with second generation antiandrogens, polyadenosine diphosphate-ribose polymerase (PARP) inhibitors, oral gonadotrophinreleasing hormone (GnRh) antagonists, estrogens, or older antiandrogens are allowedbut combinations of oral regimens only are not permitted]
Androgen deprivation therapy (ADT):
Leuprolide intramuscular (IM) or subcutaneous (SQ), 4 or 12 weeks cyclelength
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 currentlyprescribed for at least 18 weeks following registration (if on chemotherapy orimmunotherapy) 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 forpatients on any qualifying treatment (tx) regimen; ECOG PS 0, 1, 2, or 3 forpatients 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
Exclusion Criteria:
Receiving any other investigational agent which would be considered as a treatmentfor the primary neoplasm
Current inpatient hospitalization (excluding admission to the Advanced Care at Homeprogram)
Co-morbid systemic illnesses or other severe concurrent disease which, in thejudgment of the investigator, would make the patient inappropriate for entry intothis study or interfere significantly with the proper assessment of safety andtoxicity 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 studyrequirements
Patients with any severe infection within 4 weeks prior to registration including,but not limited to, hospitalization for complications of infections should not beenrolled in the trial (in the current situation, this also applies to patients withsuspected 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 priorto initiating treatment in the home would still be eligible
Study Design
Study Description
Connect with a study center
Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
United StatesActive - Recruiting
Mayo Clinic in Florida
Jacksonville 4160021, Florida 4155751 32224-9980
United StatesSite Not Available

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