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New treatment option for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Official title Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T
ClinicalTrials.gov ID: NCT06134232
What this study is testing
What is Sipuleucel-T Injection?
Sipuleucel-T Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic castration-resistant prostate cancer (mcrpc).
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
- A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- For a subject to be eligible for participation in this study, all of the following criteria must be satisfied:
- Potential people are men aged ≥18 years who are clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic...
- Have qualified for on-label PROVENGE® infusion
- Have received all 3 infusions of PROVENGE® prior to randomization
- Written informed consent provided prior to the initiation of study procedures
You likely can't join if
- A subject will not be eligible for participation in this study if any of the following criteria apply.
- Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant [hormone...
- Need for systemic chronic immunosuppressive therapy, including antitumor necrosis factor alpha monoclonal antibodies, glucocorticoids, systemic...
- Uncontrolled, concurrent illness, including, but not limited to the following: ongoing or active infection (bacterial, viral, or fungal), or...
- On experimental or investigational therapy.
See the full eligibility criteria
- For a subject to be eligible for participation in this study, all of the following criteria must be satisfied:
- Potential people are men aged ≥18 years who are clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant [hormone refractory] prostate cancer).
- Have qualified for on-label PROVENGE® infusion
- Have received all 3 infusions of PROVENGE® prior to randomization
- Written informed consent provided prior to the initiation of study procedures
- Estimated life expectancy ≥12 months
- A subject will not be eligible for participation in this study if any of the following criteria apply.
- Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant [hormone refractory] prostate cancer).
- Need for systemic chronic immunosuppressive therapy, including antitumor necrosis factor alpha monoclonal antibodies, glucocorticoids, systemic steroids, blood products, GM-CSF or granulocyte colony-stimulating factor...
- Uncontrolled, concurrent illness, including, but not limited to the following: ongoing or active infection (bacterial, viral, or fungal), or psychiatric illness that would limit compliance with study requirements, as...
- On experimental or investigational therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Tuscon, Arizona, United States
- Duarte, California, United States
- Fresno, California, United States
- San Diego, California, United States
- Lakewood, Colorado, United States
- Daytona Beach, Florida, United States
- Largo, Florida, United States
- Ocala, Florida, United States
- Riverview, Florida, United States
- Chicago Ridge, Illinois, United States
- Glenview, Illinois, United States
- New Lenox, Illinois, United States
- Carmel, Indiana, United States
- Jeffersonville, Indiana, United States
- Merrillville, Indiana, United States
- Towson, Maryland, United States
- Troy, Michigan, United States
- St Louis, Missouri, United States
- North Hills, New York, United States
- Syracuse, New York, United States
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 Tuscon, Arizona, United States; Duarte, California, United States; Fresno, California, United States; San Diego, California, United States; Lakewood, Colorado, United States; Daytona Beach, Florida, United States and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.