Trial · NCT00918385
Genomic Guided Therapy With Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer
NCT00918385, Phase 2, Terminated, Duke University; results first posted 2014-10-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Genomic Guided Therapy With Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer. Trials, record NCT00918385. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00918385
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Genomic Guided Therapy With Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer
- NCT number
- NCT00918385
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 57 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Prostate Cancer
- Interventions
- Nilutamide, Dasatinib
- First posted
- 2009-06-11
- Last updated
- 2014-10-29
- Results first posted
- 2014-10-29
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | During monotherapy ( at least 12 weeks) | PFS is the interval from start of monotherapy until first disease progression or death, whichever occurred first. |
| Secondary | Overall Response Rate of Men With High AR Activity | During monotherapy (at least 12 weeks) | Tumor response was based on Response Criteria in Solid Tumors (RECIST). Complete response (CR) is defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. |
| Secondary | Overall Response Rate of Men With Low AR Activity | During dasatinib monotherapy ( at least 12 weeks) | Tumor response is based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | During monotherapy ( at least 12 weeks) | months | MEDIAN | |
| SECONDARY | Overall Response Rate of Men With High AR Activity | During monotherapy (at least 12 weeks) | 14 subjects began treatment; 13 with response documentation are included in the calculation; 1 subject was omitted because response documentation was not provided. | percentage of patients with CR,PR | NUMBER |
| SECONDARY | Overall Response Rate of Men With Low AR Activity | During dasatinib monotherapy ( at least 12 weeks) | Of the 17 subjects treated, 15 had response documentation and are included in the calculation. Two were omitted (1 because response documentation was not provided; 1 ended treatment after 2 weeks for toxicity prior to repeat scans). | percentage of patients with CR,PR | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Arm 1=High AR Nilutamide | 2.8 | 90% Confidence Interval 2.7 to 4.4 | months | |
| Progression Free Survival (PFS) | Arm 2= Low AR Dasatinib | 2.6 | 90% Confidence Interval 1.1 to 3.0 | months | |
| Overall Response Rate of Men With High AR Activity | Arm 1=High AR Nilutamide | 0 | 95% Confidence Interval 0 to 23 | percentage of patients with CR,PR | |
| Overall Response Rate of Men With Low AR Activity | Arm 2= Low AR Dasatinib | 0 | 95% Confidence Interval 0 to 21 | percentage of patients with CR,PR |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Monotherapy | STARTED | Arm 1=High AR Nilutamide | 14 | |
| Monotherapy | STARTED | Arm 2= Low AR Dasatinib | 17 | |
| Monotherapy | COMPLETED | Arm 1=High AR Nilutamide | 12 | |
| Monotherapy | COMPLETED | Arm 2= Low AR Dasatinib | 11 | |
| Monotherapy | NOT COMPLETED | Arm 1=High AR Nilutamide | 2 | |
| Monotherapy | NOT COMPLETED | Arm 2= Low AR Dasatinib | 6 | |
| Combination Nilutamide and Dasatinib | STARTED | Arm 1=High AR Nilutamide | 12 | |
| Combination Nilutamide and Dasatinib | STARTED | Arm 2= Low AR Dasatinib | 11 | |
| Combination Nilutamide and Dasatinib | COMPLETED | Arm 1=High AR Nilutamide | 6 | |
| Combination Nilutamide and Dasatinib | COMPLETED | Arm 2= Low AR Dasatinib | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events327
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 | Anemia | Blood and lymphatic system disorders | Arm 1=High AR Nilutamide | 1 | 14 | |
| other | Anemia | Blood and lymphatic system disorders | Arm 2= Low AR Dasatinib | 1 | 17 | |
| other | Anemia | Blood and lymphatic system disorders | Combination Nilutamide and Dasatinib | 0 | 23 | |
| other | Dizziness | Nervous system disorders | Arm 1=High AR Nilutamide | 1 | 14 | |
| other | Dizziness | Nervous system disorders | Arm 2= Low AR Dasatinib | 0 | 17 | |
| other | Dizziness | Nervous system disorders | Combination Nilutamide and Dasatinib | 0 | 23 | |
| other | Obstruction, GU:Ureter | Renal and urinary disorders | Arm 1=High AR Nilutamide | 1 | 14 | |
| other | Obstruction, GU:Ureter | Renal and urinary disorders | Arm 2= Low AR Dasatinib | 0 | 17 | |
| other | Obstruction, GU:Ureter | Renal and urinary disorders | Combination Nilutamide and Dasatinib | 0 | 23 | |
| other | Eye disorders - Other | Eye disorders | Arm 1=High AR Nilutamide | 0 | 14 |
1 to 10 of 327Source ClinicalTrials.gov
See all 327 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1=High AR Nilutamide | ||
| Total, all-cause mortality | Arm 2= Low AR Dasatinib | ||
| Total, all-cause mortality | Combination Nilutamide and Dasatinib | ||
| Total, other adverse events | Arm 1=High AR Nilutamide | 3 | 14 |
| Total, other adverse events | Arm 2= Low AR Dasatinib | 1 | 17 |
| Total, other adverse events | Combination Nilutamide and Dasatinib | 1 | 23 |
| Total, serious adverse events | Arm 1=High AR Nilutamide | 14 | 14 |
| Total, serious adverse events | Arm 2= Low AR Dasatinib | 16 | 17 |
| Total, serious adverse events | Combination Nilutamide and Dasatinib | 14 | 23 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19289629 | BACKGROUND |
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 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/NCT00918385
GET https://conductscience.org/api/trials/v1/NCT00918385/events?page=2