A Phase 2 Pragmatic Clinical Trial to Evaluate Administration of Cancer Therapy in the Patients' Homes Versus in Clinic in Black Men With Advanced or Metastatic Prostate Cancer
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.
• 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. 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