Trial · NCT00779402

PROvenge Treatment and Early Cancer Treatment

NCT00779402, Phase 3, Completed, Dendreon; results first posted 2018-01-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. PROvenge Treatment and Early Cancer Treatment. Trials, record NCT00779402. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00779402

On this page

Trial

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

Title: PROvenge Treatment and Early Cancer Treatment
NCT number: NCT00779402
Status: Completed
Phases: Phase 3
Enrollment: 176 participants, actual
Lead sponsor: Dendreon
Conditions: Prostate Cancer
Interventions: Control, Sipuleucel-T
First posted: 2008-10-24
Last updated: 2018-01-29
Results first posted: 2018-01-29

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Time to Biochemical Failure Cumulative Incidence Percentile	Every 3 months post-infusion	Time to Biochemical Failure (TTBF) was the pre-specified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL
Primary	Number of Subjects That Met Biochemical Failure Status	Every 3 months post-infusion	time to biochemical Failure (TTBF) was the pre-scpecified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL.

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	Time to Biochemical Failure Cumulative Incidence Percentile	Every 3 months post-infusion	Number of subjects that met biochemical failure criteria.	Months	MEDIAN
PRIMARY	Number of Subjects That Met Biochemical Failure Status	Every 3 months post-infusion		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Category	Value	Spread	Units
Time to Biochemical Failure Cumulative Incidence Percentile	Sipuleucel-T	25th Cumulative Incidence Percentile	7.6	95% Confidence Interval 6.2 to 9.2	Months
Time to Biochemical Failure Cumulative Incidence Percentile	Control	25th Cumulative Incidence Percentile	6.8	95% Confidence Interval 6.1 to 9.5	Months
Time to Biochemical Failure Cumulative Incidence Percentile	Sipuleucel-T	50th Cumulative Incidence Percentile	14.9	95% Confidence Interval 9.8 to 16.1	Months
Time to Biochemical Failure Cumulative Incidence Percentile	Control	50th Cumulative Incidence Percentile	12.4	95% Confidence Interval 9.1 to 18.0	Months
Time to Biochemical Failure Cumulative Incidence Percentile	Sipuleucel-T	75th Cumulative Incidence Percentile	22.9	95% Confidence Interval 18.3 to 28.8	Months
Time to Biochemical Failure Cumulative Incidence Percentile	Control	75th Cumulative Incidence Percentile	24.6	95% Confidence Interval 17.9 to 54.0	Months
Number of Subjects That Met Biochemical Failure Status	Sipuleucel-T		85		Participants
Number of Subjects That Met Biochemical Failure Status	Control		45		Participants

Source ClinicalTrials.gov

Participant flow24

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

Period	Milestone	Group	Participants
Treatment Phase 1	STARTED	Sipuleucel-T	117
Treatment Phase 1	STARTED	Control	59
Treatment Phase 1	Received ≥1 Leukapherisis (Safety Set)	Sipuleucel-T	116
Treatment Phase 1	Received ≥1 Leukapherisis (Safety Set)	Control	59
Treatment Phase 1	Received ≥1 Study Product (Exposure Set)	Sipuleucel-T	113
Treatment Phase 1	Received ≥1 Study Product (Exposure Set)	Control	59
Treatment Phase 1	Received Booster Infusion	Sipuleucel-T	50
Treatment Phase 1	Received Booster Infusion	Control	30
Treatment Phase 1	COMPLETED	Sipuleucel-T	84
Treatment Phase 1	COMPLETED	Control	44

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events272

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	Sipuleucel-T	5	116	5
other	ANAEMIA	Blood and lymphatic system disorders	Control	5	59	6
other	LYMPHADENOPATHY	Blood and lymphatic system disorders	Sipuleucel-T	3	116	5
other	LYMPHADENOPATHY	Blood and lymphatic system disorders	Control	3	59	7
other	DIARRHOEA	Gastrointestinal disorders	Sipuleucel-T	14	116	19
other	DIARRHOEA	Gastrointestinal disorders	Control	13	59	15
other	CONSTIPATION	Gastrointestinal disorders	Sipuleucel-T	16	116	18
other	CONSTIPATION	Gastrointestinal disorders	Control	5	59	6
other	NAUSEA	Gastrointestinal disorders	Sipuleucel-T	15	116	17
other	NAUSEA	Gastrointestinal disorders	Control	5	59	6

1 to 10 of 272Source ClinicalTrials.gov

See all 272 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sipuleucel-T	20	116
Total, all-cause mortality	Control	9	59
Total, other adverse events	Sipuleucel-T	114	116
Total, other adverse events	Control	57	59
Total, serious adverse events	Sipuleucel-T	31	116
Total, serious adverse events	Control	19	59

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23896100	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 comparisons3

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

Comparison	Source
Sipuleucel-T vs Control: Number of Subjects That Met Biochemical Failure Status	Trial comparisons
Sipuleucel-T vs Control: deaths from any cause	Trial comparisons
Sipuleucel-T vs Control: 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/NCT00779402

GET https://conductscience.org/api/trials/v1/NCT00779402/flow?page=2

API reference For AI assistants