Clinical trial NCT06134232: Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Keywords: Single Dose
Sipuleucel-T
Immune Response Rate
Safety
Adenocarcinoma of the Prostate
Lead sponsor: Dendreon
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

Brief summary: A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).

Detailed description: Those enrolled in the Booster Study will have had their course of treatment with PROVENGE® immunotherapy and then randomized to the Booster Study to be treated with a single booster dose of sipuleucel-T.

Eligibility criteria: Inclusion Criteria:

For a subject to be eligible for participation in this study, all of the following criteria must be satisfied:

1. 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).
2. Have qualified for on-label PROVENGE® infusion
3. Have received all 3 infusions of PROVENGE® prior to randomization
4. Written informed consent provided prior to the initiation of study procedures
5. 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.

1. Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \[hormone refractory\] prostate cancer).
2. Need for systemic chronic immunosuppressive therapy (eg, antitumor necrosis factor alpha monoclonal antibodies, glucocorticoids).
3. 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.
4. On experimental or investigational therapy.

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Primary outcomes:
measure: Assess humoral immune response to PAP and PA2024 after booster infusion
timeFrame: Once all subjects have completed the study through the 5 year Overall Survival Period
measure: Geometric Mean Ration of the difference in Humor Response
timeFrame: Once all subjects have completed the study through the 5 year Overall Survival Period
Secondary outcomes:
measure: Evaluate the incidence of adverse events including laboratory abnormalities after a single booster does of sipuleucel-T
timeFrame: Once all subjects have completed the study through the 5 year Overall Survival Period
Other outcomes:
measure: Assess biomarkers of response to treatment
timeFrame: Once all subjects have completed the study through the 5 year Overall Survival Period
measure: Assess Antigen Response
timeFrame: Once all subjects have completed the study through the 5 year Overall Survival Period
Locations:
Study officials:
affiliation: Dendreon Pharmaceuticals, LLC
name: Nadeem Sheikh, PhD
role: STUDY_DIRECTOR
affiliation: Chesapeake Urology
name: Benjamin Lowentritt, MD
role: STUDY_CHAIR
References: