Trial · NCT00676650
Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy
NCT00676650, Phase 3, Terminated, Pfizer; results first posted 2013-03-08
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy. Trials, record NCT00676650. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00676650
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy
- NCT number
- NCT00676650
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 873 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Prostatic Neoplasms
- Interventions
- Prednisone, sunitinib, Placebo, Prednisone
- First posted
- 2008-05-13
- Last updated
- 2013-03-08
- Results first posted
- 2013-03-08
- Limitations and caveats
- A complete analysis was not performed due to the sponsors early termination of the clinical trial.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Baseline up to 32 months | OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus \[-\] date of randomization plus \[+\] 1) divided (/) 30.4. |
| Secondary | Progression-Free Survival (PFS) | Baseline, every 8 weeks up to 123 weeks | PFS is the period from randomization until disease progression or death on study. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. PFS (weeks) calculated as (first event date - randomization date + 1)/7.02 |
| Secondary | Percent of Participants With Objective Response (OR) | Baseline, every 8 weeks up to 123 weeks | OR defined as the percent (%) of participants with confirmed Complete Response (CR) (disappearance of all target lesions) or Partial Response (PR) (\>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to the full analysis population. Confirmed responses were those that persist on repeat imagining study \>= 4 weeks after initial documentation of response. |
| Secondary | Duration of Response (DR) | Baseline, every 8 weeks up to 123 weeks | Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause - the date of the first CR or PR that was subsequently confirmed plus 1 divided by 7.02. DR calculated for the subgroup of participants with a confirmed objective tumor response |
| Secondary | Change From Baseline in Pain Severity | Day 1 through Day 7 every 28 days (every cycle) up to 29 months | Pain severity recorded on a numerical scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicated greater level of pain. The pain score for each cycle averaged for the 7 days. |
| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) | Baseline, every 4 weeks up to 123 weeks | FACT-P is a validated, self-administered instrument used to assess health-related quality of life and prostate cancer-specific symptoms. Scores ranged from 0 (not at all) to 4 (very much). It is 27-item FACT-General and 12 items for the prostate cancer specific concerns. The 27 items in FACT-G are grouped into 4 domains: physical well-being, social/family well-being, emotional well-being and functional well-being. The 12 prostate cancer symptoms items focus on pain (3 items), urination problems (3 items), sexual functions (2 items), weight loss, appetite, overall comfort, and bowel movement. |
| Secondary | Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score | Baseline, every 4 weeks up to 123 weeks | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Overall scores range from 0 to 1, with lower scores representing a higher level of dysfunction. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Baseline up to 32 months | Full analysis (FA) population: all participants who were randomized, with study drug assignment designated according to initial randomization, regaradless of whether participant received study drug according to the randomization schedule. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | Baseline, every 8 weeks up to 123 weeks | FA Population | weeks | MEDIAN |
| SECONDARY | Percent of Participants With Objective Response (OR) | Baseline, every 8 weeks up to 123 weeks | FA Population | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DR) | Baseline, every 8 weeks up to 123 weeks | Data not summarized, study terminated early | ||
| SECONDARY | Change From Baseline in Pain Severity | Day 1 through Day 7 every 28 days (every cycle) up to 29 months | Data not summarized, study terminated early | ||
| SECONDARY | Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) | Baseline, every 4 weeks up to 123 weeks | Data not summarized, study terminated early | ||
| SECONDARY | Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score | Baseline, every 4 weeks up to 123 weeks | Data not summarized, study terminated early |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Sunitinib and Prednisone | 13.1 | 95% Confidence Interval 12.0 to 14.1 | months | |
| Overall Survival (OS) | Placebo and Prednisone | 11.8 | 95% Confidence Interval 10.8 to 14.2 | months | |
| Progression-Free Survival (PFS) | Sunitinib and Prednisone | 24.1 | 95% Confidence Interval 23.4 to 28.1 | weeks | |
| Progression-Free Survival (PFS) | Placebo and Prednisone | 17.9 | 95% Confidence Interval 15.8 to 24.1 | weeks | |
| Percent of Participants With Objective Response (OR) | Sunitinib and Prednisone | 6.1 | 95% Confidence Interval 3.8 to 9.3 | percentage of participants | |
| Percent of Participants With Objective Response (OR) | Placebo and Prednisone | 1.8 | 95% Confidence Interval 0.4 to 5.2 | 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 | Sunitinib and Prednisone | 584 | |
| Overall Study | STARTED | Placebo and Prednisone | 289 | |
| Overall Study | Treated | Sunitinib and Prednisone | 581 | |
| Overall Study | Treated | Placebo and Prednisone | 285 | |
| Overall Study | COMPLETED | Sunitinib and Prednisone | 0 | |
| Overall Study | COMPLETED | Placebo and Prednisone | 0 | |
| Overall Study | NOT COMPLETED | Sunitinib and Prednisone | 584 | |
| Overall Study | NOT COMPLETED | Placebo and Prednisone | 289 |
Source ClinicalTrials.gov
Adverse events594
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 | Sunitinib and Prednisone | 140 | 581 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo and Prednisone | 53 | 285 | |
| other | Leukopenia | Blood and lymphatic system disorders | Sunitinib and Prednisone | 60 | 581 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo and Prednisone | 2 | 285 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sunitinib and Prednisone | 84 | 581 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo and Prednisone | 1 | 285 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sunitinib and Prednisone | 72 | 581 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo and Prednisone | 8 | 285 | |
| other | Abdominal pain | Gastrointestinal disorders | Sunitinib and Prednisone | 41 | 581 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo and Prednisone | 13 | 285 |
1 to 10 of 594Source ClinicalTrials.gov
See all 594 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sunitinib and Prednisone | ||
| Total, all-cause mortality | Placebo and Prednisone | ||
| Total, other adverse events | Sunitinib and Prednisone | 573 | 581 |
| Total, other adverse events | Placebo and Prednisone | 256 | 285 |
| Total, serious adverse events | Sunitinib and Prednisone | 275 | 581 |
| Total, serious adverse events | Placebo and Prednisone | 86 | 285 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24323035 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sunitinib and Prednisone vs Placebo and Prednisone: 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/NCT00676650
GET https://conductscience.org/api/trials/v1/NCT00676650/events?page=2