At a glance
ClinicalIndex Comparison Record- ✓Metastatic disease (soft tissue and/or bony metastases)
- ✓PSA ≥5 ng/mL with stable or rising trend
- ✓Tumor progression after hormonal therapy
- ✓Prior hormonal therapy (castration by orchiectomy or LHRH agonist) with documented castration testosterone levels <50 ng/dL
- ✕Visceral organ metastases (liver, lung, brain) or cytologically positive effusions
- ✕Metastatic disease expected to require radiation therapy within 4 months
- ✕Concurrent therapy with experimental agents
- ✕Systemic corticosteroids >40 mg hydrocortisone daily within previous 6 months (without prior approval)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge) for Asymptomatic Metastatic Hormome-Refractory Prostate Cancer
In Brief
A Phase 3 clinical trial evaluating sipuleucel-T and Placebo for Prostate Cancer. Completed, enrolled 127 participants across 34 sites.
Detailed Summary
Rationale: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known if vaccine therapy is effective for prostate cancer. Purpose: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Study Details
Timeline
Interventions
Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
Approximately one-third of the autologous quiescent antigen presenting cells (APCs) prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.