Trial · NCT03686683
Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer
NCT03686683, Phase 3, Completed, Dendreon; results first posted 2024-10-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer. Trials, record NCT03686683. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03686683
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer
- NCT number
- NCT03686683
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 532 participants, actual
- Lead sponsor
- Dendreon
- Conditions
- Adenocarcinoma of the Prostate
- Interventions
- sipuleucel-T
- First posted
- 2018-09-27
- Last updated
- 2024-10-08
- Results first posted
- 2024-10-08
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Sipuleucel-T Measured as the Percentage of Subjects Without Histological Reclassification (Gleason Group Upgrade). | Once all participants have completed at least 3 years following randomization | Percentage of participants without histological reclassification (Gleason group upgrade) within 36 months of randomization as determined by Blinded Independent Central Review (BICR) o Upgrade is defined as participants at randomization with either International Society of Urological Pathology (ISUP) Grade Group 1 (Gleason 3+3) upgraded to Grade Group 2 (Gleason 3+4) or higher or participants at randomization with Grade Group 2 upgraded to Grade Group 3 (Gleason 4+3) or higher. |
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 | Efficacy of Sipuleucel-T Measured as the Percentage of Subjects Without Histological Reclassification (Gleason Group Upgrade). | Once all participants have completed at least 3 years following randomization | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Efficacy of Sipuleucel-T Measured as the Percentage of Subjects Without Histological Reclassification (Gleason Group Upgrade). | Treatment Group: Sipuleucel-T | 108 | Participants | ||
| Efficacy of Sipuleucel-T Measured as the Percentage of Subjects Without Histological Reclassification (Gleason Group Upgrade). | Control Arm: Active Surveillance | 48 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Group: Sipuleucel-T | 356 | |
| Overall Study | STARTED | Control Arm: Active Surveillance | 176 | |
| Overall Study | COMPLETED | Treatment Group: Sipuleucel-T | 262 | |
| Overall Study | COMPLETED | Control Arm: Active Surveillance | 118 | |
| Overall Study | NOT COMPLETED | Treatment Group: Sipuleucel-T | 94 | |
| Overall Study | NOT COMPLETED | Control Arm: Active Surveillance | 58 |
Source ClinicalTrials.gov
Adverse events250
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 | Chills | General disorders | Treatment Group: Sipuleucel-T | 70 | 345 | |
| other | Chills | General disorders | Control Arm: Active Surveillance | 2 | 176 | |
| other | Fatigue | General disorders | Treatment Group: Sipuleucel-T | 61 | 345 | |
| other | Fatigue | General disorders | Control Arm: Active Surveillance | 6 | 176 | |
| other | Erectile dysfunction | Reproductive system and breast disorders | Treatment Group: Sipuleucel-T | 39 | 345 | |
| other | Erectile dysfunction | Reproductive system and breast disorders | Control Arm: Active Surveillance | 19 | 176 | |
| other | Headache | Nervous system disorders | Treatment Group: Sipuleucel-T | 38 | 345 | |
| other | Headache | Nervous system disorders | Control Arm: Active Surveillance | 3 | 176 | |
| other | Paraesthesia | Nervous system disorders | Treatment Group: Sipuleucel-T | 38 | 345 | |
| other | Paraesthesia | Nervous system disorders | Control Arm: Active Surveillance | 0 | 176 |
1 to 10 of 250Source ClinicalTrials.gov
See all 250 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Group: Sipuleucel-T | 10 | 356 |
| Total, all-cause mortality | Control Arm: Active Surveillance | 5 | 176 |
| Total, other adverse events | Treatment Group: Sipuleucel-T | 321 | 345 |
| Total, other adverse events | Control Arm: Active Surveillance | 133 | 176 |
| Total, serious adverse events | Treatment Group: Sipuleucel-T | 74 | 345 |
| Total, serious adverse events | Control Arm: Active Surveillance | 22 | 176 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment Group: Sipuleucel-T vs Control Arm: Active Surveillance: Efficacy of Sipuleucel-T Measured as the Percentage of Subjects Without Histological Reclassification (Gleason Group Upgrade). | Trial comparisons |
| Treatment Group: Sipuleucel-T vs Control Arm: Active Surveillance: deaths from any cause | Trial comparisons |
| Treatment Group: Sipuleucel-T vs Control Arm: Active Surveillance: 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.
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/NCT03686683
GET https://conductscience.org/api/trials/v1/NCT03686683/events?page=2