Trial · NCT01981122

A Study of Sipuleucel-T With Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer

NCT01981122, Phase 2, Completed, Dendreon; results first posted 2018-09-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Sipuleucel-T With Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer. Trials, record NCT01981122. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01981122

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Trial

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

Title: A Study of Sipuleucel-T With Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer
NCT number: NCT01981122
Status: Completed
Phases: Phase 2
Enrollment: 52 participants, actual
Lead sponsor: Dendreon
Conditions: Metastatic Prostate Cancer
Interventions: sipuleucel-T, enzalutamide
First posted: 2013-11-11
Last updated: 2018-10-24
Results first posted: 2018-09-25

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	To Evaluate Peripheral PA2024-specific T Cell Proliferation Response to Sipuleucel-T Over Time Via a T Cell Stimulation Index (SI).	Each patient was followed for up to 52 weeks after the first dose of sipuleucel-T. Immune sample draws during the treatment period (Week 0 through Week 4) were to be performed at the patient's pre-leukapheresis visits (Pre-Leuk 2 and Pre-Leuk 3).	PA2024-specific T cell proliferation responses over time will be compared between the concurrent arm and sequential arm using a repeated measurement mixed model analysis. The unit of analysis for the T cell proliferation data is the stimulation index, defined as the median 3H uptake of 3 wells exposed to antigen divided by the median 3H thymidine uptake of 3 wells exposed to media. The stimulation index will be log-transformed prior to analysis.

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	To Evaluate Peripheral PA2024-specific T Cell Proliferation Response to Sipuleucel-T Over Time Via a T Cell Stimulation Index (SI).	Each patient was followed for up to 52 weeks after the first dose of sipuleucel-T. Immune sample draws during the treatment period (Week 0 through Week 4) were to be performed at the patient's pre-leukapheresis visits (Pre-Leuk 2 and Pre-Leuk 3).	Summary of Cellular Proliferation Data Through Week 52. All patients with reported data at a specified time-point were analyzed. Number of patients at each time-point differed across the time-points resulting in patient numbers at each time-point that are not equal to the total number of patients analyzed.	10^3 cells/mL	MEAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
To Evaluate Peripheral PA2024-specific T Cell Proliferation Response to Sipuleucel-T Over Time Via a T Cell Stimulation Index (SI).	Concurrent Arm	PA2024 Baseline	2.48	Standard Deviation 4.76	10^3 cells/mL
To Evaluate Peripheral PA2024-specific T Cell Proliferation Response to Sipuleucel-T Over Time Via a T Cell Stimulation Index (SI).	Sequential Arm	PA2024 Baseline	1.48	Standard Deviation .92	10^3 cells/mL
To Evaluate Peripheral PA2024-specific T Cell Proliferation Response to Sipuleucel-T Over Time Via a T Cell Stimulation Index (SI).	Concurrent Arm	PA2024 Pre-leuk 2	8.76	Standard Deviation 13.40	10^3 cells/mL
To Evaluate Peripheral PA2024-specific T Cell Proliferation Response to Sipuleucel-T Over Time Via a T Cell Stimulation Index (SI).	Sequential Arm	PA2024 Pre-leuk 2	5.08	Standard Deviation 7.07	10^3 cells/mL
To Evaluate Peripheral PA2024-specific T Cell Proliferation Response to Sipuleucel-T Over Time Via a T Cell Stimulation Index (SI).	Concurrent Arm	PA2024 Pre-leuk 3	23.33	Standard Deviation 16.98	10^3 cells/mL
To Evaluate Peripheral PA2024-specific T Cell Proliferation Response to Sipuleucel-T Over Time Via a T Cell Stimulation Index (SI).	Sequential Arm	PA2024 Pre-leuk 3	13.96	Standard Deviation 11.90	10^3 cells/mL
To Evaluate Peripheral PA2024-specific T Cell Proliferation Response to Sipuleucel-T Over Time Via a T Cell Stimulation Index (SI).	Concurrent Arm	PA2024 Week 6	17.36	Standard Deviation 14.39	10^3 cells/mL
To Evaluate Peripheral PA2024-specific T Cell Proliferation Response to Sipuleucel-T Over Time Via a T Cell Stimulation Index (SI).	Sequential Arm	PA2024 Week 6	12.72	Standard Deviation 11.83	10^3 cells/mL
To Evaluate Peripheral PA2024-specific T Cell Proliferation Response to Sipuleucel-T Over Time Via a T Cell Stimulation Index (SI).	Concurrent Arm	PA2024 Week 10	15.48	Standard Deviation 9.53	10^3 cells/mL
To Evaluate Peripheral PA2024-specific T Cell Proliferation Response to Sipuleucel-T Over Time Via a T Cell Stimulation Index (SI).	Sequential Arm	PA2024 Week 10	10.90	Standard Deviation 9.07	10^3 cells/mL

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Concurrent Arm	25
Overall Study	STARTED	Sequential Arm	27
Overall Study	COMPLETED	Concurrent Arm	11
Overall Study	COMPLETED	Sequential Arm	7
Overall Study	NOT COMPLETED	Concurrent Arm	14
Overall Study	NOT COMPLETED	Sequential Arm	20

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	Concurrent Arm	3	25	4
other	Anaemia	Blood and lymphatic system disorders	Sequential Arm	2	27	2
other	Iron Deficiency Anaemia	Blood and lymphatic system disorders	Concurrent Arm	0	25	0
other	Iron Deficiency Anaemia	Blood and lymphatic system disorders	Sequential Arm	1	27	1
other	Angina Pectoris	Cardiac disorders	Concurrent Arm	0	25	0
other	Angina Pectoris	Cardiac disorders	Sequential Arm	1	27	1
other	Aortic Valve Incompetence	Cardiac disorders	Concurrent Arm	0	25	0
other	Aortic Valve Incompetence	Cardiac disorders	Sequential Arm	1	27	1
other	Atrial Fibrillation	Cardiac disorders	Concurrent Arm	1	25	1
other	Atrial Fibrillation	Cardiac disorders	Sequential Arm	1	27	1

1 to 10 of 362Source ClinicalTrials.gov

See all 362 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Concurrent Arm	14	25
Total, all-cause mortality	Sequential Arm	15	27
Total, other adverse events	Concurrent Arm	23	25
Total, other adverse events	Sequential Arm	27	27
Total, serious adverse events	Concurrent Arm	2	25
Total, serious adverse events	Sequential Arm	9	27

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/NCT01981122

GET https://conductscience.org/api/trials/v1/NCT01981122/events?page=2

API reference For AI assistants