Trial · NCT00519285

Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer

NCT00519285, Phase 3, Completed, Sanofi; results first posted 2013-10-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer. Trials, record NCT00519285. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00519285

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Trial

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

Title: Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer
NCT number: NCT00519285
Status: Completed
Phases: Phase 3
Enrollment: 1,224 participants, actual
Lead sponsor: Sanofi
Conditions: Prostatic Neoplasms, Neoplasm Metastasis
Interventions: Aflibercept, Placebo (for aflibercept), Docetaxel, Prednisone or Prednisolone
First posted: 2007-08-22
Last updated: 2016-07-22
Other registries' IDs: eudract:2006-004756-20
Results first posted: 2013-10-10
Limitations and caveats: Pain response initially defined as a key secondary endpoint together with PSA response, time to occurence of SRE and PFS was finally considered as an exploratory endpoint in final statistical analysis plan.

Source ClinicalTrials.gov

Registered outcomes11

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

List	Outcome	Time frame	Description
Primary	Overall Survival Time	From randomization up to the cut-off date (median follow-up of 35.4 months)	Overall survival (OS) time was measured as the time from date of randomization to the date of death due to any cause. The median OS time and its 95.6% confidence interval were estimated using the Kaplan-Meier method. In the absence of confirmation of death, the participant was censored at the last date he/she was known to be alive or the study cut-off date (when 873 deaths have occurred), whichever was earlier.
Secondary	Prostate Specific Antigen Response Rate	Before randomization (baseline) then every 3 weeks up to PSA progression (≥25% increase) or the cut-off date, whichever occurred first	Prostate specific antigen (PSA) response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed at least 3 weeks later. Increases of any magnitude during the first 12 weeks were ignored in determining PSA response.
Secondary	Time to Skeletal Related Events	From randomization up to the cut-off date (median follow-up of 35.4 months)	Skeletal Related Events (SRE) included pathological fractures and/or spinal cord compression, need for bone irradiation, including radioisotopes or bone surgery, change in antineoplastic therapy to treat bone pain. Time to SRE was defined as the time from the date of randomization to the date of occurence of the first event defining a SRE or death due to any cause, whichever occurred first. The median time to SRE and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of SRE, the participant was censored at the last date he/she was known to be alive or the study cut-off date, whichever was earlier.
Secondary	Progression Free Survival Time	From randomization up to the cut-off date (median follow-up of 35.4 months)	Disease progression was defined as a composite of: Radiological tumor progression (≥20% increase in target lesions, or appearance of at least 2 new bone lesions); PSA progression (≥25% increase in PSA level confirmed 3 weeks later); Pain progression (increase in pain intensity or in analgesic consumption for cancer related pain confirmed 3 weeks later); Radiotherapy for cancer related symptoms; Occurence of Skeletal related events (SRE). Progression Free survival (PFS) time was measured as the time from the date of randomization up to the date of occurrence of the first event defining a disease progression or death due to any cause, whichever occurred first. The median PFS time and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of disease progression, the participant was censored at the the date of last assessment without evidence of progression or the study cut-off date, whichever was earlier.
Secondary	Tumor Response Rate in Participants With Measurable Disease	Before randomization (baseline) then every 3 months up to tumor progression (≥25% increase) or the cut-off date, whichever occurred first	Tumor response was defined as either a Complete Response (disappearance of all target lesions) or a Partial Response (≥30% decrease from baseline in target lesions) as assessed by Response Evaluation Criteria In Solid Tumors (RECIST)version 1.0.
Secondary	Prostate Specific Antigen Progression-free Survival Time	From randomization up to the cut-off date (median follow-up of 35.4 months)	Prostate specific antigen (PSA) progression was defined as ≥25% increase in PSA level confirmed 3 weeks later, above the nadir in participants who had achieved a PSA response, or above the baseline in participants who hadn't achieved a PSA response. PSA progression-free survival (PFS) time was defined as the time from the date of randomization up to the date of the first documented PSA progression or death due to any cause, whichever occurred first. The median PSA-PFS time and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of PSA progression or death, the participant was censored at the the date of last assessment without evidence of progression or the study cut-off date, whichever was earlier.
Secondary	Pain Progression-free Survival Time	From randomization up to the cut-off date (median follow-up of 35.4 months)	Pain progression was defined as either ≥1-point increase in Present Pain Intensity (PPI) score or ≥25% increase in Analgesics Score (AS) confirmed at least 3 weeks later, or requirement for palliative radiotherapy. PPI scale is a self-report 0-5 scale to assess pain intensity - a score 0 reflects no pain, a score 5 reflects excruciating pain. AS is a scoring method to assess analgesics consumption. Each analgesic is scored 1 or 4 depending on the analgesic type and dose. AS is the sum of the analgesic scores. Pain progression-free survival (PFS) time was measured as the time from the date of randomization up to the date of first pain progression or death due to any cause, whichever occurred first. The median pain-PFS and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of event, the participant was censored at the the date of last assessment without evidence of pain progression or the study cut-off date, whichever was earlier.
Secondary	Pain Response Rate	Before randomization (baseline) then every 3 weeks up to pain progression or the cut-off date, whichever occurred first	Pain response was defined as either a ≥2-point decrease from baseline in Present Pain Intensity (PPI) score without increase in Analgesics Score (AS), or a ≥50% decrease from baseline in AS without increase in the PPI score confirmed at least 3 weeks later. Increases in PPI or AS during the first 12 weeks were ignored in determining pain response.
Secondary	Change From Baseline in Functional Assessment of Cancer Therapy-Prostate Total Score as a Measure of Health Related Quality of Life	Before randomization (baseline) then every 3 weeks until disease progression or administration of further antitumor therapy, whichever came first	Functional Assessment of Cancer Therapy-Prostate (FACT-P) is a 39-item participant questionnaire that measures the concerns of patients with prostate cancer. It consists of 5 subscales assessing physical well-being, social/family well-being, emotional well-being, functional well-being, and prostate-specific concerns. FACT-P total score is the sum of the 5 subscores. It ranges from 0 to 156 with higher score indicating better quality of life.
Secondary	Number of Participants With Adverse Events as a Measure of Safety	From first dose of study treatment (aflibercept/placebo or docetaxel whichever came first) to last dose of study treatment (aflibercept/placebo or docetaxel whichever came last) + 30 days	Adverse Events (AE) are any unfavorable and unintended sign, symptom, syndrome or illness observed by the investigator or reported by the participant during the study. AE were collected at regular intervals throughout the study then graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v.3.0).

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival Time	From randomization up to the cut-off date (median follow-up of 35.4 months)	The analysis was performed on the Intent-to-treat (ITT) population (i.e all randomized participants according to the treatment assigned regardless of the drug actually received).~At the cut-off date, 873 deaths had occurred, 445 in the Placebo group and 428 in the Aflibercept group.	months	MEDIAN
SECONDARY	Prostate Specific Antigen Response Rate	Before randomization (baseline) then every 3 weeks up to PSA progression (≥25% increase) or the cut-off date, whichever occurred first	The analysis was performed on the ITT population evaluable for PSA response (i.e. with a baseline PSA ≥10 ng/mL).	percentage of participants	NUMBER
SECONDARY	Time to Skeletal Related Events	From randomization up to the cut-off date (median follow-up of 35.4 months)	The analysis was performed on the ITT population.~At the cut-off date, SRE or death had occurred in 1013 participants, 516 in the Placebo group and 497 in the Aflibercept group.	months	MEDIAN
SECONDARY	Progression Free Survival Time	From randomization up to the cut-off date (median follow-up of 35.4 months)	The analysis was performed on the ITT population.~At the cut-off date, disease progression or death had occurred in 1184 participants, 592 in each treatment group.	months	MEDIAN
SECONDARY	Tumor Response Rate in Participants With Measurable Disease	Before randomization (baseline) then every 3 months up to tumor progression (≥25% increase) or the cut-off date, whichever occurred first	The analysis was performed on the ITT population evaluable for tumor response (i.e. received at least one dose of study drugs (aflibercept/placebo or docetaxel), had no important deviations to protocol and was evaluable for response as per RECIST version 1.0).	percentage of participants	NUMBER
SECONDARY	Prostate Specific Antigen Progression-free Survival Time	From randomization up to the cut-off date (median follow-up of 35.4 months)	The analysis was performed in the ITT population evaluable for PSA progression (i.e. with an evaluable baseline PSA).~At the cut-off date, PSA progression or death had occurred in 1138 participants, 571 in the Placebo group and 567 in the Aflibercept group.	months	MEDIAN
SECONDARY	Pain Progression-free Survival Time	From randomization up to the cut-off date (median follow-up of 35.4 months)	The analysis was performed on the ITT population evaluable for pain progression (i.e. with no pain or with stable pain at baseline).~At the cut-off date, pain progression or death had occurred in 507 participants, 263 in the Placebo group and 244 in the Aflibercept group.	months	MEDIAN
SECONDARY	Pain Response Rate	Before randomization (baseline) then every 3 weeks up to pain progression or the cut-off date, whichever occurred first	The analysis was performed in the ITT population evaluable for pain response (i.e. stable analgesia at baseline and, baseline PPI ≥2 and/or baseline AS ≥10 points).	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Functional Assessment of Cancer Therapy-Prostate Total Score as a Measure of Health Related Quality of Life	Before randomization (baseline) then every 3 weeks until disease progression or administration of further antitumor therapy, whichever came first	The analysis was performed on the ITT population evaluable for Health related quality of life (i.e. with baseline and at least one post-baseline evaluable FACT-P questionnaire).	units on a scale	MEAN
SECONDARY	Number of Participants With Adverse Events as a Measure of Safety	From first dose of study treatment (aflibercept/placebo or docetaxel whichever came first) to last dose of study treatment (aflibercept/placebo or docetaxel whichever came last) + 30 days	The analysis was performed on the safety population (i.e. all randomized and treated participants according to the treatment actually received). Six participants in the Placebo group who received at least one dose of aflibercept in error were considered in the Aflibercept group.	participants	NUMBER

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group48

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

Outcome	Group	Value	Spread	Units
Overall Survival Time	Placebo	21.22	95% Confidence Interval 19.614 to 23.754	months
Overall Survival Time	Aflibercept	22.14	95% Confidence Interval 20.304 to 24.082	months
Prostate Specific Antigen Response Rate	Placebo	63.5	95% Confidence Interval 59.5 to 67.5	percentage of participants
Prostate Specific Antigen Response Rate	Aflibercept	68.6	95% Confidence Interval 64.7 to 72.4	percentage of participants
Time to Skeletal Related Events	Placebo	14.98	95% Confidence Interval 13.733 to 16.427	months
Time to Skeletal Related Events	Aflibercept	15.31	95% Confidence Interval 14.127 to 16.657	months
Progression Free Survival Time	Placebo	6.24	95% Confidence Interval 5.585 to 6.899	months
Progression Free Survival Time	Aflibercept	6.90	95% Confidence Interval 6.209 to 7.359	months
Tumor Response Rate in Participants With Measurable Disease	Placebo	28.1	95% Confidence Interval 23.2 to 33.1	percentage of participants
Tumor Response Rate in Participants With Measurable Disease	Aflibercept	38.7	95% Confidence Interval 33.4 to 44.0	percentage of participants

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow10

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	612
Overall Study	STARTED	Aflibercept	612
Overall Study	TREATED	Placebo	604
Overall Study	TREATED	Aflibercept	605
Overall Study	Still Treated at Cut-off Date	Placebo	1
Overall Study	Still Treated at Cut-off Date	Aflibercept	2
Overall Study	COMPLETED	Placebo	0
Overall Study	COMPLETED	Aflibercept	0
Overall Study	NOT COMPLETED	Placebo	612
Overall Study	NOT COMPLETED	Aflibercept	612

Source ClinicalTrials.gov

Adverse events638

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
other	Urinary tract infection	Infections and infestations	Placebo	38	598
other	Urinary tract infection	Infections and infestations	Aflibercept	39	611
other	Nasopharyngitis	Infections and infestations	Placebo	36	598
other	Nasopharyngitis	Infections and infestations	Aflibercept	23	611
other	Decreased appetite	Metabolism and nutrition disorders	Placebo	110	598
other	Decreased appetite	Metabolism and nutrition disorders	Aflibercept	190	611
other	Insomnia	Psychiatric disorders	Placebo	44	598
other	Insomnia	Psychiatric disorders	Aflibercept	45	611
other	Dysgeusia	Nervous system disorders	Placebo	107	598
other	Dysgeusia	Nervous system disorders	Aflibercept	108	611

1 to 10 of 638Source ClinicalTrials.gov

See all 638 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Aflibercept
Total, other adverse events	Placebo	551	598
Total, other adverse events	Aflibercept	573	611
Total, serious adverse events	Placebo	184	598
Total, serious adverse events	Aflibercept	331	611

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23742877	RESULT	PubMed
24722180	DERIVED	PubMed
25515657	DERIVED	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 comparisons1

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

Comparison
Aflibercept vs Placebo: 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.

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.

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