Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorDendreon
About this trial
A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Sipuleucel-T Injection
DrugSingle Infusion
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Booster ArmExperimental treatment 1 intervention
Group B: No BoosterNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Assess humoral immune response to PAP and PA2024 after booster infusion
To assess the humoral response ((i.e. antibody titer) to PAP and PA2024 after booster infusion in subjects with metastatic castrate-resistant prostate cancer who have received a single booster dose of sipuleucel-T vs those subjects who have not
Time frame
Once all subjects have completed the study through the 5 year Overall Survival PeriodSecondary outcomes
1
Evaluate the incidence of adverse events including laboratory abnormalities after a single booster does of sipuleucel-T
For all subjects enrolled in the study. Evaluation will include descriptive statistics by treatment arm and in the aggregate of the incidence of adverse events (Number of participants with adverse events (AEs), and the incidence of clinically significant laboratory abnormalities (Number of participants experiencing clinically significant laboratory abnormalities) after initial treatment and booster (Week 28) within and between groups.
Time frame
Once all subjects have completed the study through the 5 year Overall Survival Period2
Evaluate Overall Survival
Overall survival after booster infusion of sipuleucel-T defined as the time from randomization to death due to any cause.
Time frame
Once all subjects have completed the study through the 5 year Overall Survival Period. To evaluate safety by determining the incidence of adverse events (AEs), assessing laboratory data for clinically significant laboratory abnormalities, and evaluatingOther outcomes
1
Assess biomarkers of response to treatment
Biomarkers, such as cytokines, will be assessed for response to booster treatment using appropriate descriptive statistics assessed over time and at Week 28. Nominal p-values will be provided without multiplicity adjustment .appropriate descriptive statistics assessed over time and at Week 28.
Time frame
Once all subjects have completed the study through the 5 year Overall Survival Period2
Assess Antigen Response
Comparison of (over time and at Week 38), the number of subjects per treatment arm with PAP and PA2024 antigen positive response using descriptive statistics.
Time frame
Once all subjects have completed the study through the 5 year Overall Survival PeriodSponsors and contacts
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Source ClinicalTrials.gov