Trial · NCT01306890
A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer
NCT01306890, Completed, Dendreon; results first posted 2019-06-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer. Trials, record NCT01306890. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01306890
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer
- NCT number
- NCT01306890
- Status
- Completed
- Enrollment
- 1,976 participants, actual
- Lead sponsor
- Dendreon
- Conditions
- Advanced Prostate Cancer, Prostatic Neoplasms
- Interventions
- sipuleucel-T
- First posted
- 2011-03-02
- Last updated
- 2019-06-07
- Results first posted
- 2019-06-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects | Every 3 months for a minimum of 3 years | The incidence rate of CVEs (cardiovascular events) was estimated as the number of new events per 100 patient years of follow-up in the overall sample of men with advanced-stage or metastatic prostate cancer and in men with or without castration. |
| Secondary | Survival | Every 3 months for a minimum of 3 years | To quantify survival by estimating the median time of survival in all subjects using the Kaplan-Meier method. |
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 | To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects | Every 3 months for a minimum of 3 years | events per 100 patient years | NUMBER | |
| SECONDARY | Survival | Every 3 months for a minimum of 3 years | months | MEDIAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects | Sipuleucel-T | 1.2 | events per 100 patient years | ||
| Survival | Sipuleucel-T | 30.7 | 95% Confidence Interval 28.6 to 32.2 | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sipuleucel-T | 1,976 | |
| Overall Study | COMPLETED | Sipuleucel-T | 457 | |
| Overall Study | NOT COMPLETED | Sipuleucel-T | 1,519 |
Source ClinicalTrials.gov
Adverse events185
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 | Subdural haematoma | Injury, poisoning and procedural complications | Sipuleucel-T | 2 | 1,902 | 2 |
| other | Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sipuleucel-T | 1 | 1,902 | 1 |
| other | Aphasia | Nervous system disorders | Sipuleucel-T | 1 | 1,902 | 1 |
| other | Cerebral haemorrhage | Nervous system disorders | Sipuleucel-T | 1 | 1,902 | 1 |
| other | Cerebral infarction | Nervous system disorders | Sipuleucel-T | 1 | 1,902 | 1 |
| other | Cerebrovascular accident | Nervous system disorders | Sipuleucel-T | 2 | 1,902 | 3 |
| other | Ischaemic stroke | Nervous system disorders | Sipuleucel-T | 1 | 1,902 | 1 |
| other | Seizure | Nervous system disorders | Sipuleucel-T | 1 | 1,902 | 1 |
| other | Transient ischaemic attack | Nervous system disorders | Sipuleucel-T | 2 | 1,902 | 2 |
| serious | Anaemia | Blood and lymphatic system disorders | Sipuleucel-T | 7 | 1,902 | 14 |
1 to 10 of 185Source ClinicalTrials.gov
See all 185 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sipuleucel-T | 1,223 | 1,976 |
| Total, other adverse events | Sipuleucel-T | 12 | 1,902 |
| Total, serious adverse events | Sipuleucel-T | 260 | 1,902 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01306890
GET https://conductscience.org/api/trials/v1/NCT01306890/events?page=2