Phase 3
Completed N=512
Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
Source: ClinicalTrials.gov NCT00065442 ↗Enrolled (actual)
512
Serious AEs
24.1%
Results posted
Sep 2010
Primary outcomePrimary: Overall Survival — 21.7; 25.8 Months — p=0.032
Summary
Provenge is an investigational product designed to activate a man's own antigen presenting cells, a type of immune cell, so that they can detect prostate cancer cells and initiate an immune response against them.
Having completed Phase 1 and Phase 2 clinical trials, Provenge is now at the Phase 3 level. One important Phase 3 trial of Provenge has been completed; the current trial is also a Phase 3 study.
If you decide to participate and are eligible, you will be enrolled in the study and randomly assigned to receive either active product or placebo. There are two chances in three that you will receive Provenge. After receiving treatment, you will be monitored at regular intervals until the study endpoints are met. At the end of the trial, men who received placebo will have the opportunity to be treated with active product in another study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
21.7; 25.8 | 0.032 sig |
| SECONDARY Time to Objective Disease Progression |
14.4; 14.6 | 0.628 |
Eligibility Criteria
To qualify for this trial, you must have ALL of the following:
- Histologically documented adenocarcinoma of the prostate
- Cancer that has progressed while on adequate hormone therapy. This state of the disease is androgen independent prostate cancer (AIPC).
- Cancer that has spread outside the prostate (metastatic) to lymph nodes or bone. Please note that if your cancer has spread to organs (e.g., liver, lung, brain), you are not eligible for the study.
- The absence of or minimal current cancer-related pain
Please note that there are additional eligibility criteria. The study center will determine if you meet all of the criteria.
Study personnel will explain the trial in detail and answer any questions you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, study personnel will explain the reasons.
Data sourced from ClinicalTrials.gov (NCT00065442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.