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Compares treatment options for Biochemically Recurrent Prostate Carcinoma
Official title Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recurrent and Metastatic Prostate Cancer
ClinicalTrials.gov ID: NCT07073794
What this study is testing
What is Cancer Therapeutic Procedure?
Cancer Therapeutic Procedure is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for biochemically recurrent prostate carcinoma.
Also referred to as anticancer therapy, Cancer Therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- Black or African American male patients with locally advanced, high risk, biochemical recurrent, or metastatic prostate cancer who are currently...
- Androgen deprivation therapy (ADT):
- Leuprolide intramuscular (IM) or subcutaneous (SQ), 4 or 12 weeks cycle length
You likely can't join if
- 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...
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure
See the full eligibility 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...
- 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...
- 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...
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.