Trial · NCT01254864
Maximal Androgen Depletion Followed by Randomization of Maximal Androgen Ablation With Molecular Targeted Therapies
NCT01254864, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2025-01-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Maximal Androgen Depletion Followed by Randomization of Maximal Androgen Ablation With Molecular Targeted Therapies. Trials, record NCT01254864. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01254864
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Maximal Androgen Depletion Followed by Randomization of Maximal Androgen Ablation With Molecular Targeted Therapies
- NCT number
- NCT01254864
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 190 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Prostate Cancer
- Interventions
- Abiraterone Acetate, Prednisone, Sunitinib, Dasatinib
- First posted
- 2010-12-07
- Last updated
- 2025-01-27
- Results first posted
- 2025-01-27
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Treatment Failure (TTF) | Up to 11 months | Time to treatment failure (TTF), defined as time from randomization (AP+S or AP+D) to progression per PCWG2 criteria or death. |
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 | Time to Treatment Failure (TTF) | Up to 11 months | The first group/arm was not reported as the outcome measure of time to treatment failure is defined as the time from randomization (subjects were randomized after being in the first group/arm) to progression. | Months | MEDIAN |
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 |
|---|---|---|---|---|---|
| Time to Treatment Failure (TTF) | AP + Sunitinib | 5.5 | 95% Confidence Interval 4.6 to 6.8 | Months | |
| Time to Treatment Failure (TTF) | AP + Dasatinib | 5.7 | 95% Confidence Interval 3.8 to 7.4 | Months |
Source ClinicalTrials.gov
Participant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Abiraterone Acetate+Prednisone(AP) Phase | STARTED | Abiraterone Acetate + Prednisone (AP) | 179 | |
| Abiraterone Acetate+Prednisone(AP) Phase | STARTED | AP + Sunitinib | 0 | |
| Abiraterone Acetate+Prednisone(AP) Phase | STARTED | AP + Dasatinib | 0 | |
| Abiraterone Acetate+Prednisone(AP) Phase | Randomized to AP + Sunitinib | Abiraterone Acetate + Prednisone (AP) | 64 | |
| Abiraterone Acetate+Prednisone(AP) Phase | Randomized to AP + Sunitinib | AP + Sunitinib | 0 | |
| Abiraterone Acetate+Prednisone(AP) Phase | Randomized to AP + Sunitinib | AP + Dasatinib | 0 | |
| Abiraterone Acetate+Prednisone(AP) Phase | Randomized to AP + Dasatinib | Abiraterone Acetate + Prednisone (AP) | 68 | |
| Abiraterone Acetate+Prednisone(AP) Phase | Randomized to AP + Dasatinib | AP + Sunitinib | 0 | |
| Abiraterone Acetate+Prednisone(AP) Phase | Randomized to AP + Dasatinib | AP + Dasatinib | 0 | |
| Abiraterone Acetate+Prednisone(AP) Phase | Crossover to AP + Sunitinib | Abiraterone Acetate + Prednisone (AP) | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events580
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 | Abdominal Pain | Gastrointestinal disorders | Abiraterone Acetate + Prednisone (AP) | 0 | 179 | |
| other | Abdominal Pain | Gastrointestinal disorders | AP + Sunitinib | 3 | 64 | |
| other | Abdominal Pain | Gastrointestinal disorders | AP + Sunitinib → AP + Dasatanib | 0 | 39 | |
| other | Abdominal Pain | Gastrointestinal disorders | AP + Dasatinib | 4 | 68 | |
| other | Abdominal Pain | Gastrointestinal disorders | AP + Dasatanib → AP + Sunitinib | 2 | 32 | |
| other | Activated Partial Thromboplastin Time Prolonged | Investigations | Abiraterone Acetate + Prednisone (AP) | 0 | 179 | |
| other | Activated Partial Thromboplastin Time Prolonged | Investigations | AP + Sunitinib | 0 | 64 | |
| other | Activated Partial Thromboplastin Time Prolonged | Investigations | AP + Sunitinib → AP + Dasatanib | 2 | 39 | |
| other | Activated Partial Thromboplastin Time Prolonged | Investigations | AP + Dasatinib | 0 | 68 | |
| other | Activated Partial Thromboplastin Time Prolonged | Investigations | AP + Dasatanib → AP + Sunitinib | 0 | 32 |
1 to 10 of 580Source ClinicalTrials.gov
See all 580 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abiraterone Acetate + Prednisone (AP) | 0 | 179 |
| Total, all-cause mortality | AP + Sunitinib | 1 | 64 |
| Total, all-cause mortality | AP + Sunitinib → AP + Dasatanib | 0 | 39 |
| Total, all-cause mortality | AP + Dasatinib | 0 | 68 |
| Total, all-cause mortality | AP + Dasatanib → AP + Sunitinib | 0 | 32 |
| Total, other adverse events | Abiraterone Acetate + Prednisone (AP) | 46 | 179 |
| Total, other adverse events | AP + Sunitinib | 33 | 64 |
| Total, other adverse events | AP + Sunitinib → AP + Dasatanib | 31 | 39 |
| Total, other adverse events | AP + Dasatinib | 43 | 68 |
| Total, other adverse events | AP + Dasatanib → AP + Sunitinib | 24 | 32 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT01254864
GET https://conductscience.org/api/trials/v1/NCT01254864/flow?page=2