RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares cancer treatment at home with treatment in a clinic. It is for Black men with prostate cancer that is high-risk, has spread, or shows rising PSA blood test levels after treatment. The study looks at safety, side effects, and which setting patients prefer and feel more satisfied with.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be a Black or African American man age 18 or older with prostate cancer that meets the study rules.
  • Be receiving or planning to start an allowed standard treatment: leuprolide, degarelix, cabazitaxel, pembrolizumab, or zoledronic acid or denosumab with prostate cancer treatment. The treatment must follow accepted medical guidelines.
  • Have at least one treatment given by a home health nurse. Other allowed medicines may be taken with it, but pills alone do not qualify.
  • Expect to stay on treatment for at least 18 weeks after joining for chemotherapy or immunotherapy, or 24 weeks for other treatments.
  • Live in the home care provider’s service area.
  • Meet the study’s limits on help needed for daily activities: an ECOG activity score of 0–2, or 0–3 for hormone-lowering treatment called ADT, with or without certain other hormone medicines.
  • Sign a written consent form, be willing and able to follow study rules, and complete surveys alone or with help.
  • Agree to follow birth control rules if you can father a child.

Who can't join

  • Be receiving another experimental medicine to treat the prostate cancer.
  • Be staying in a hospital now, unless enrolled in the Advanced Care at Home program.
  • Have another serious illness that the study doctor thinks would make joining unsafe or make treatment safety hard to judge.
  • Have an uncontrolled illness, such as an active infection, heart failure with symptoms, unstable chest pain, an abnormal heartbeat, a heart attack within 6 months, or trouble healing wounds. Mental health or social problems that prevent following study rules also exclude you.
  • Have had a severe infection within 4 weeks before joining, including suspected or confirmed COVID-19.
  • Expect to need major surgery during study treatment. Radiation treatment is allowed.
  • Not pass the screening that checks whether your home and social situation support safe home treatment.
  • Have received home treatment in another CARE Beyond Walls study. You may still qualify if you left that study before home treatment began.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

FL