Trial · NCT00901342
Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer
NCT00901342, Phase 2, Completed, Dendreon; results first posted 2017-04-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer. Trials, record NCT00901342. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00901342
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer
- NCT number
- NCT00901342
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 104 participants, actual
- Lead sponsor
- Dendreon
- Conditions
- Prostate Cancer
- Interventions
- sipuleucel-T
- First posted
- 2009-05-13
- Last updated
- 2017-05-23
- Results first posted
- 2017-04-12
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC) | Day 0 (first infusion) and up to 3 infusions at 2-week intervals |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC) | Day 0 (first infusion) and up to 3 infusions at 2-week intervals | Participants who Received At least 1 Infusion | participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC) | Sipuleucel-T | 98 | participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sipuleucel-T | 104 | |
| Overall Study | Received at Least 1 Infusion | Sipuleucel-T | 98 | |
| Overall Study | COMPLETED | Sipuleucel-T | 89 | |
| Overall Study | NOT COMPLETED | Sipuleucel-T | 15 |
Source ClinicalTrials.gov
Adverse events38
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 | 6 | 98 | 14 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Sipuleucel-T | 8 | 98 | 8 |
| other | Dizziness | Nervous system disorders | Sipuleucel-T | 9 | 98 | 10 |
| other | Headache | Nervous system disorders | Sipuleucel-T | 8 | 98 | 11 |
| other | Anxiety | Psychiatric disorders | Sipuleucel-T | 7 | 98 | 7 |
| other | Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Sipuleucel-T | 6 | 98 | 7 |
| other | Asthenia | General disorders | Sipuleucel-T | 6 | 98 | 6 |
| other | Citrate toxicity | Injury, poisoning and procedural complications | Sipuleucel-T | 6 | 98 | 8 |
| other | Hypertension | Vascular disorders | Sipuleucel-T | 6 | 98 | 7 |
| other | Oedema peripheral | General disorders | Sipuleucel-T | 5 | 98 | 5 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sipuleucel-T | 4 | 98 |
| Total, other adverse events | Sipuleucel-T | 91 | 98 |
| Total, serious adverse events | Sipuleucel-T | 13 | 98 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00901342
GET https://conductscience.org/api/trials/v1/NCT00901342/events?page=2