To hear about similar clinical trials, please enter your email below
Trial Title:
Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T
NCT ID:
NCT06134232
Condition:
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Single Dose
Sipuleucel-T
Immune Response Rate
Safety
Adenocarcinoma of the Prostate
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sipuleucel-T Injection
Description:
Single Infusion
Arm group label:
Booster Arm
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.
Criteria for 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.
-
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 27, 2023
Completion date:
June 30, 2032
Lead sponsor:
Agency:
Dendreon
Agency class:
Industry
Source:
Dendreon
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06134232
