Trial · NCT01431391
Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
NCT01431391, Phase 2, Completed, Dendreon; results first posted 2017-05-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer. Trials, record NCT01431391. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01431391
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
- NCT number
- NCT01431391
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 68 participants, actual
- Lead sponsor
- Dendreon
- Conditions
- Prostatic Neoplasm, Prostate Cancer, Prostatic Adenocarcinoma
- Interventions
- sipuleucel-T, leuprolide acetate
- First posted
- 2011-09-09
- Last updated
- 2017-05-30
- Results first posted
- 2017-05-30
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024 | PA2024 ELISPOT counts at Month 24 | Immune response at month 24 as evaluated by IFN-γ ELISPOT specific for PA2024 following sipuleucel-T/ADT treatment regimens to determine if order of administration impacted immune response. |
| Secondary | Percentage of Participants With Immune Response As Evaluated by IFN-γ ELISPOT Specific for PA2024 | Month 24 | A participant was considered to have an immune response it the post-baseline PA2024-specific IFN-g ELISPOT count was \>18 |
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 | Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024 | PA2024 ELISPOT counts at Month 24 | The immune response population was defined as all randomized subjects who received 3 infusions of sipuleucel-T. | IFN-γ ELISPOT (per 300,000 PBMC) | MEAN |
| SECONDARY | Percentage of Participants With Immune Response As Evaluated by IFN-γ ELISPOT Specific for PA2024 | Month 24 | The immune response population was defined as all randomized subjects who received 3 infusions of sipuleucel-T. | percentage of participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024 | Arm 1: Sipuleucel-T Followed by ADT | 81.0 | Standard Error 28.0 | IFN-γ ELISPOT (per 300,000 PBMC) | |
| Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024 | Arm 2: ADT Followed by Sipuleucel-T | 61.1 | Standard Error 23.7 | IFN-γ ELISPOT (per 300,000 PBMC) | |
| Percentage of Participants With Immune Response As Evaluated by IFN-γ ELISPOT Specific for PA2024 | Arm 1:Sipuleucel-T Followed by ADT | 88 | percentage of participants | ||
| Percentage of Participants With Immune Response As Evaluated by IFN-γ ELISPOT Specific for PA2024 | Arm 2: ADT Followed by Sipuleucel-T | 85 | percentage of participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1:Sipuleucel-T Followed by ADT | 34 | |
| Overall Study | STARTED | Arm 2: ADT Followed by Sipuleucel-T | 34 | |
| Overall Study | Received ≥1 Leaukapheresis | Arm 1:Sipuleucel-T Followed by ADT | 34 | |
| Overall Study | Received ≥1 Leaukapheresis | Arm 2: ADT Followed by Sipuleucel-T | 34 | |
| Overall Study | COMPLETED | Arm 1:Sipuleucel-T Followed by ADT | 26 | |
| Overall Study | COMPLETED | Arm 2: ADT Followed by Sipuleucel-T | 30 | |
| Overall Study | NOT COMPLETED | Arm 1:Sipuleucel-T Followed by ADT | 8 | |
| Overall Study | NOT COMPLETED | Arm 2: ADT Followed by Sipuleucel-T | 4 |
Source ClinicalTrials.gov
Adverse events146
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 | Hot flush | Vascular disorders | Arm 1: Sipuleucel-T Followed by ADT | 19 | 34 | 20 |
| other | Hot flush | Vascular disorders | Arm 2: ADT Followed by Sipuleucel-T | 23 | 34 | 23 |
| other | Fatigue | General disorders | Arm 1: Sipuleucel-T Followed by ADT | 13 | 34 | 19 |
| other | Fatigue | General disorders | Arm 2: ADT Followed by Sipuleucel-T | 21 | 34 | 26 |
| other | Headache | Nervous system disorders | Arm 1: Sipuleucel-T Followed by ADT | 9 | 34 | 10 |
| other | Headache | Nervous system disorders | Arm 2: ADT Followed by Sipuleucel-T | 7 | 34 | 7 |
| other | Chills | General disorders | Arm 1: Sipuleucel-T Followed by ADT | 9 | 34 | 19 |
| other | Chills | General disorders | Arm 2: ADT Followed by Sipuleucel-T | 6 | 34 | 8 |
| other | Citrate toxicity | Injury, poisoning and procedural complications | Arm 1: Sipuleucel-T Followed by ADT | 6 | 34 | 12 |
| other | Citrate toxicity | Injury, poisoning and procedural complications | Arm 2: ADT Followed by Sipuleucel-T | 6 | 34 | 13 |
1 to 10 of 146Source ClinicalTrials.gov
See all 146 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: Sipuleucel-T Followed by ADT | ||
| Total, all-cause mortality | Arm 2: ADT Followed by Sipuleucel-T | ||
| Total, other adverse events | Arm 1: Sipuleucel-T Followed by ADT | 33 | 34 |
| Total, other adverse events | Arm 2: ADT Followed by Sipuleucel-T | 34 | 34 |
| Total, serious adverse events | Arm 1: Sipuleucel-T Followed by ADT | 1 | 34 |
| Total, serious adverse events | Arm 2: ADT Followed by Sipuleucel-T | 5 | 34 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm 1: Sipuleucel-T Followed by ADT vs Arm 2: ADT Followed by Sipuleucel-T: 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/NCT01431391
GET https://conductscience.org/api/trials/v1/NCT01431391/events?page=2