Trial · NCT01133704
Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
NCT01133704, Phase 3, Completed, Dendreon; results first posted 2010-09-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer. Trials, record NCT01133704. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01133704
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
- NCT number
- NCT01133704
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 98 participants, actual
- Lead sponsor
- Dendreon
- Conditions
- Hormone-Refractory Prostate Cancer
- Interventions
- sipuleucel-T, APC-Placebo
- First posted
- 2010-05-31
- Last updated
- 2010-09-08
- Results first posted
- 2010-09-02
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Time to Disease Progression | from randomization to 36 months | Overall time to disease progression in subjects with asymptomatic metastatic hormone-refractory prostate cancer treated with sipuleucel-T (APC8015) compared to overall time to disease progression in subjects treated with placebo. |
| Secondary | Overall Survival | Time from randomization until 36 months | Subjects were followed for 3 years from the time of randomization or until death. |
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 Time to Disease Progression | from randomization to 36 months | Weeks | MEDIAN | |
| SECONDARY | Overall Survival | Time from randomization until 36 months | All randomized participants | Months | 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 Time to Disease Progression | Sipuleucel-T (APC8015) | 10.9 | 95% Confidence Interval 9.3 to 17.7 | Weeks | |
| Overall Time to Disease Progression | Placebo | 9.9 | 95% Confidence Interval 8.4 to 18.0 | Weeks | |
| Overall Survival | Sipuleucel-T (APC8015) | 19.0 | 95% Confidence Interval 13.6 to 31.9 | Months | |
| Overall Survival | Placebo | 15.7 | 95% Confidence Interval 12.8 to 25.4 | Months |
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 | Sipuleucel-T (APC8015) | 65 | |
| Overall Study | STARTED | Placebo | 33 | |
| Overall Study | COMPLETED | Sipuleucel-T (APC8015) | 16 | |
| Overall Study | COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Sipuleucel-T (APC8015) | 49 | |
| Overall Study | NOT COMPLETED | Placebo | 26 |
Source ClinicalTrials.gov
Adverse events178
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 | Sipuleucel-T (APC8015) | 13 | 65 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 31 | |
| other | Constipation | Gastrointestinal disorders | Sipuleucel-T (APC8015) | 5 | 65 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 4 | 31 | |
| other | Diarrhoea | Gastrointestinal disorders | Sipuleucel-T (APC8015) | 4 | 65 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 31 | |
| other | Dyspepsia | Gastrointestinal disorders | Sipuleucel-T (APC8015) | 1 | 65 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 2 | 31 | |
| other | Hypoaesthesia Oral | Gastrointestinal disorders | Sipuleucel-T (APC8015) | 4 | 65 | |
| other | Hypoaesthesia Oral | Gastrointestinal disorders | Placebo | 1 | 31 |
1 to 10 of 178Source ClinicalTrials.gov
See all 178 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sipuleucel-T (APC8015) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Sipuleucel-T (APC8015) | 63 | 65 |
| Total, other adverse events | Placebo | 29 | 31 |
| Total, serious adverse events | Sipuleucel-T (APC8015) | 13 | 65 |
| Total, serious adverse events | Placebo | 9 | 31 |
Source ClinicalTrials.gov
Papers2
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 (APC8015) vs 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/NCT01133704
GET https://conductscience.org/api/trials/v1/NCT01133704/events?page=2