Trial · NCT01420965
Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer
NCT01420965, Phase 2, Terminated, Augusta University; results first posted 2019-07-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer. Trials, record NCT01420965. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01420965
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer
- NCT number
- NCT01420965
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Augusta University
- Conditions
- Prostatic Neoplasms
- Interventions
- CT-011 (Anti-PD1 Antibody), Sipuleucel-T (Provenge), Cyclophosphamide
- First posted
- 2011-08-22
- Last updated
- 2019-07-10
- Results first posted
- 2019-07-10
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determine Feasibility of Provenge Plus Low-dose Cyclophosphamide as Well as the Immune Efficacy of Provenge Alone Versus Provenge Plus Low-dose Cyclophosphamide and Anti PD1 Monoclonal Antibodies (CT011) on the Change in Specific Immune Response. | 2 years | |
| Secondary | Determine Whether the Combination of Low Dose-Cyclophosphamide and Anti PD1 Monoclonal Antibodies (CT-011) With Provenge(tm) Lead to Improvement in Increase Progression Free Survival (PFS) and Overall Survival (OS) in Patients With Advanced, Min... | 2 years |
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 | Determine Feasibility of Provenge Plus Low-dose Cyclophosphamide as Well as the Immune Efficacy of Provenge Alone Versus Provenge Plus Low-dose Cyclophosphamide and Anti PD1 Monoclonal Antibodies (CT011) on the Change in Specific Immune Response. | 2 years | Study discontinued due to drug supply issues; no analysis performed or meaningful data derived. | ||
| SECONDARY | Determine Whether the Combination of Low Dose-Cyclophosphamide and Anti PD1 Monoclonal Antibodies (CT-011) With Provenge(tm) Lead to Improvement in Increase Progression Free Survival (PFS) and Overall Survival (OS) in Patients With Advanced, Min... | 2 years | Study discontinued due to drug supply issues; no analysis performed or meaningful data derived. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A | 2 | |
| Overall Study | STARTED | Arm B | 2 | |
| Overall Study | STARTED | Arm C | 3 | |
| Overall Study | COMPLETED | Arm A | 1 | |
| Overall Study | COMPLETED | Arm B | 1 | |
| Overall Study | COMPLETED | Arm C | 3 | |
| Overall Study | NOT COMPLETED | Arm A | 1 | |
| Overall Study | NOT COMPLETED | Arm B | 1 | |
| Overall Study | NOT COMPLETED | Arm C | 0 |
Source ClinicalTrials.gov
Adverse events3
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 |
|---|---|---|---|---|---|---|
| serious | Negative infusion reaction | Immune system disorders | Arm A | 0 | 2 | 0 |
| serious | Negative infusion reaction | Immune system disorders | Arm B | 1 | 2 | 1 |
| serious | Negative infusion reaction | Immune system disorders | Arm C | 0 | 3 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A | ||
| Total, all-cause mortality | Arm B | ||
| Total, all-cause mortality | Arm C | ||
| Total, other adverse events | Arm A | 0 | 2 |
| Total, other adverse events | Arm B | 0 | 2 |
| Total, other adverse events | Arm C | 0 | 3 |
| Total, serious adverse events | Arm A | 0 | 2 |
| Total, serious adverse events | Arm B | 1 | 2 |
| Total, serious adverse events | Arm C | 0 | 3 |
Source ClinicalTrials.gov
Papers3
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/NCT01420965
GET https://conductscience.org/api/trials/v1/NCT01420965/registered