Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T
An Open -Label, Multicenter Study of Subjects With Metastatic Castrate-Resistant Prostate Cancer Treated With PROVENGE ® and Boosted With A Single Infusion of Sipuleucel-T to Measure Immune Response
About This Trial
- This study is testing whether giving an extra booster dose of the immunotherapy treatment PROVENGE can help strengthen the immune system's response against advanced prostate cancer.
- It is designed for men whose cancer has spread and is no longer responding to standard hormone therapy, but who currently have few or no symptoms.
- To join, you must have already completed the standard series of three PROVENGE infusions and have an expected survival time of at least one year.
- Before considering this trial, you should know that you cannot participate if you are taking medications that weaken the immune system, such as steroids, or if you have an active, serious infection.
More Information
- A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is testing whether giving an extra booster dose of the immunotherapy treatment PROVENGE can help strengthen the immune system's response against advanced prostate cancer.
Study Details
- Start Date: October 2, 2023
- Lead Sponsor: Dendreon
Full Eligibility Criteria
Inclusion Criteria
For a subject to be eligible for participation in this study, all of the following
criteria must be satisfied:
- Potential subjects 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
Exclusion Criteria
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 (G-CSF), any vaccinations, or experimental and investigational therapies (see Section 6.3.1)
- 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 well as any condition that would preclude a subject from completing PROVENGE® or sipuleucel-T treatment.
- On experimental or investigational therapy.
Treatments
- Drug: Sipuleucel-T Injection