Prostate Cancer
Conditions
Keywords
prostate cancer, prostate, AIPC, androgen-independent, androgen independent, hormone insensitive, hormone-insensitive, PSA, prostatic adenocarcinoma, hormone-refractory, hormone refractory, HRPC, LHRH, immune therapy, immunotherapy, vaccine, dendritic cells, antigen-presenting cells, antigen presenting cells, cancer vaccine, therapeutic vaccine, therapeutic cancer vaccine, recombinant, biological, biopharmaceutical, biotechnology, biotech
Brief 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.
Detailed description
The trial is being conducted at multiple study centers throughout the United States. The trial is a double-blind, placebo-controlled trial. Participants must meet specific eligibility criteria. Study personnel will determine your eligibility in a telephone interview and through routine medical tests (physical exam, blood tests, imaging scans) done at a study center. If you qualify for and decide to participate in the trial, you will have three product administrations over the course of one month.
Interventions
BIOLOGICALSipuleucel-T
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with a PAP-GM-CSF. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
BIOLOGICALAPC-Placebo
Each dose of APC-Placebo contains approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
Sponsors
Dendreon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Event-driven timeframe. Final analysis at 331 events. | Time from randomization until death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Objective Disease Progression | Analysis conducted at the time of overall survival analysis | Measured by imaging studies; confirmed by independent imaging review |
Countries
Canada, United States
Participant flow
Recruitment details
Participants were randomized between August 2003 and November 2007 across 75 clinical trial sites.
Pre-assignment details
Participants were screened for evaluation of subject eligibility and performance of baseline tests/procedures.
Participants by arm
| Arm | Count |
|---|---|
| APC-Placebo All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals. | 171 |
| Sipuleucel-T All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart. | 341 |
| Total | 512 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 121 | 210 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 9 |
Baseline characteristics
| Characteristic | APC-Placebo | Sipuleucel-T | Total |
|---|---|---|---|
| Age Continuous | 70.1 years STANDARD_DEVIATION 9 | 71.1 years STANDARD_DEVIATION 8.9 | 70.8 years STANDARD_DEVIATION 8.9 |
| Age, Customized | 70 years | 72 years | 71 years |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 171 Participants | 341 Participants | 512 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 162 / 168 | 334 / 338 |
| serious Total, serious adverse events | 40 / 168 | 82 / 338 |
Outcome results
Primary
Overall Survival
Time from randomization until death due to any cause.
Time frame: Event-driven timeframe. Final analysis at 331 events.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| APC-Placebo | Overall Survival | 21.7 Months |
| Sipuleucel-T | Overall Survival | 25.8 Months |
p-value: 0.03295% CI: [0.614, 0.979]Regression, Cox
p-value: 0.02395% CI: [0.608, 0.965]Log Rank
Secondary
Time to Objective Disease Progression
Measured by imaging studies; confirmed by independent imaging review
Time frame: Analysis conducted at the time of overall survival analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| APC-Placebo | Time to Objective Disease Progression | 14.4 Weeks |
| Sipuleucel-T | Time to Objective Disease Progression | 14.6 Weeks |
p-value: 0.62895% CI: [0.773, 1.169]Log Rank