Trial · NCT00065442
Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
NCT00065442, Phase 3, Completed, Dendreon; results first posted 2010-09-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy. Trials, record NCT00065442. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00065442
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
- NCT number
- NCT00065442
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 512 participants, actual
- Lead sponsor
- Dendreon
- Conditions
- Prostate Cancer
- Interventions
- Sipuleucel-T, APC-Placebo
- First posted
- 2003-07-24
- Last updated
- 2010-09-06
- Results first posted
- 2010-09-06
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Event-driven timeframe. Final analysis at 331 events. | Time from randomization until death due to any cause. |
| Secondary | Time to Objective Disease Progression | Analysis conducted at the time of overall survival analysis | Measured by imaging studies; confirmed by independent imaging review |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Event-driven timeframe. Final analysis at 331 events. | Months | MEDIAN | |
| SECONDARY | Time to Objective Disease Progression | Analysis conducted at the time of overall survival analysis | Weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | APC-Placebo | 21.7 | 95% Confidence Interval 17.7 to 23.8 | Months | |
| Overall Survival | Sipuleucel-T | 25.8 | 95% Confidence Interval 22.8 to 27.7 | Months | |
| Time to Objective Disease Progression | APC-Placebo | 14.4 | 95% Confidence Interval 11.7 to 15.0 | Weeks | |
| Time to Objective Disease Progression | Sipuleucel-T | 14.6 | 95% Confidence Interval 11.7 to 15.6 | Weeks |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | APC-Placebo | 171 | |
| Overall Study | STARTED | Sipuleucel-T | 341 | |
| Overall Study | COMPLETED | APC-Placebo | 46 | |
| Overall Study | COMPLETED | Sipuleucel-T | 121 | |
| Overall Study | NOT COMPLETED | APC-Placebo | 125 | |
| Overall Study | NOT COMPLETED | Sipuleucel-T | 220 |
Source ClinicalTrials.gov
Adverse events362
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | APC-Placebo | 21 | 168 | |
| other | Anaemia | Blood and lymphatic system disorders | Sipuleucel-T | 50 | 338 | |
| other | Constipation | Gastrointestinal disorders | APC-Placebo | 24 | 168 | |
| other | Constipation | Gastrointestinal disorders | Sipuleucel-T | 45 | 338 | |
| other | Diarrhoea | Gastrointestinal disorders | APC-Placebo | 17 | 168 | |
| other | Diarrhoea | Gastrointestinal disorders | Sipuleucel-T | 36 | 338 | |
| other | Nausea | Gastrointestinal disorders | APC-Placebo | 35 | 168 | |
| other | Nausea | Gastrointestinal disorders | Sipuleucel-T | 95 | 338 | |
| other | Vomiting | Gastrointestinal disorders | APC-Placebo | 20 | 168 | |
| other | Vomiting | Gastrointestinal disorders | Sipuleucel-T | 60 | 338 |
1 to 10 of 362Source ClinicalTrials.gov
See all 362 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | APC-Placebo | ||
| Total, all-cause mortality | Sipuleucel-T | ||
| Total, other adverse events | APC-Placebo | 162 | 168 |
| Total, other adverse events | Sipuleucel-T | 334 | 338 |
| Total, serious adverse events | APC-Placebo | 40 | 168 |
| Total, serious adverse events | Sipuleucel-T | 82 | 338 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sipuleucel-T vs APC-Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00065442
GET https://conductscience.org/api/trials/v1/NCT00065442/events?page=2