Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT07073794
Eligibility Criteria:
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. 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07073794
Study Brief:
Protocol Section:
NCT07073794