Trial · NCT01487863

Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Resistant Prostate Cancer

NCT01487863, Phase 2, Completed, Dendreon; results first posted 2017-06-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Resistant Prostate Cancer. Trials, record NCT01487863. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01487863

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Resistant Prostate Cancer
NCT number: NCT01487863
Status: Completed
Phases: Phase 2
Enrollment: 69 participants, actual
Lead sponsor: Dendreon
Conditions: Prostate Cancer Metastatic, Hormone Refractory Prostate Cancer, Castration-resistant Prostate Cancer
Interventions: sipuleucel-T, abiraterone acetate
First posted: 2011-12-08
Last updated: 2019-03-19
Results first posted: 2017-06-12

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Cumulative CD54 Upregulation Ratio Between the Cohorts.	Over the course of sipuleucel-T therapy (approximately 1 month)	An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.

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	Cumulative CD54 Upregulation Ratio Between the Cohorts.	Over the course of sipuleucel-T therapy (approximately 1 month)	The efficacy population is defined as all randomized subjects. All the subjects in the efficacy population were analyzed according to the treatment that they were randomized to receive.	Ratio ofCD54 molecules on BDS65:FP cells	MEAN

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
Cumulative CD54 Upregulation Ratio Between the Cohorts.	Concurrent Arm		36.72	Standard Error 2.32	Ratio ofCD54 molecules on BDS65:FP cells
Cumulative CD54 Upregulation Ratio Between the Cohorts.	Sequential Arm		41.61	Standard Error 2.30	Ratio ofCD54 molecules on BDS65:FP cells

Source ClinicalTrials.gov

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Concurrent Arm	35
Overall Study	STARTED	Sequential Arm	34
Overall Study	Subjects Randomized (Efficacy Analysis)	Concurrent Arm	35
Overall Study	Subjects Randomized (Efficacy Analysis)	Sequential Arm	34
Overall Study	Rcvd ≥1 Leukapheresis (Safety Analysis)	Concurrent Arm	35
Overall Study	Rcvd ≥1 Leukapheresis (Safety Analysis)	Sequential Arm	34
Overall Study	COMPLETED	Concurrent Arm	16
Overall Study	COMPLETED	Sequential Arm	15
Overall Study	NOT COMPLETED	Concurrent Arm	19
Overall Study	NOT COMPLETED	Sequential Arm	19

Source ClinicalTrials.gov

Adverse events202

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	Concurrent Arm	2	35	2
other	Anaemia	Blood and lymphatic system disorders	Sequential Arm	7	34	12
other	Vertigo	Ear and labyrinth disorders	Concurrent Arm	2	35	2
other	Vertigo	Ear and labyrinth disorders	Sequential Arm	1	34	1
other	Nausea	Gastrointestinal disorders	Concurrent Arm	8	35	9
other	Nausea	Gastrointestinal disorders	Sequential Arm	10	34	12
other	Paraesthesia Oral	Gastrointestinal disorders	Concurrent Arm	8	35	12
other	Paraesthesia Oral	Gastrointestinal disorders	Sequential Arm	7	34	14
other	Constipation	Gastrointestinal disorders	Concurrent Arm	4	35	4
other	Constipation	Gastrointestinal disorders	Sequential Arm	7	34	8

1 to 10 of 202Source ClinicalTrials.gov

See all 202 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Concurrent Arm	19	35
Total, all-cause mortality	Sequential Arm	19	34
Total, other adverse events	Concurrent Arm	35	35
Total, other adverse events	Sequential Arm	32	34
Total, serious adverse events	Concurrent Arm	7	35
Total, serious adverse events	Sequential Arm	14	34

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37058234	DERIVED

Source PubMed

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Concurrent Arm vs Sequential Arm: deaths from any cause	Trial comparisons
Concurrent Arm vs Sequential Arm: serious adverse events	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01487863

GET https://conductscience.org/api/trials/v1/NCT01487863/events?page=2

API reference For AI assistants