Trial · NCT00570700
Trial of Dasatinib (Sprycel®) in Subjects With Hormone-refractory Prostate Cancer
NCT00570700, Phase 2, Completed, University of California, Irvine; results first posted 2018-05-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Dasatinib (Sprycel®) in Subjects With Hormone-refractory Prostate Cancer. Trials, record NCT00570700. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00570700
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Dasatinib (Sprycel®) in Subjects With Hormone-refractory Prostate Cancer
- NCT number
- NCT00570700
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- University of California, Irvine
- Conditions
- Hormone-refractory Prostate Cancer, Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Prostate Cancer, Recurrent Prostate Cancer
- Interventions
- Dasatinib
- First posted
- 2007-12-11
- Last updated
- 2019-02-26
- Results first posted
- 2018-05-25
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Disease Control (DC) (Based on PSA, Bone Scan, FACT-P, RECIST) | From day 56 (8 weeks) and every 8 weeks thereafter until the date of first documented progression or date of death from any cause, whichever came first, assessed until death, the patient withdraws consent, or the study ends, up to 2 years | A "positive effect" will be defined as a complete response, partial response, or stable disease. "Lack of positive effect" will be defined as progressive disease. Subjects with a mixed response should be continued on therapy until they either fulfill the criteria for positive effect or lack of positive effect, with evaluation every 56 days. The disease control (DC) rate was evaluated as a composite endpoint of the treatment effect on four parameters: 1) Prostate-specific antigen (PSA), 2) measurable disease (if present) by RECIST criteria, 3) bone scan, and 4) quality-of-life as measured by the FACT-P questionnaire. |
| Secondary | Time to Prostate-specific Antigen (PSA) Progression | From initial date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | Time to PSA progression, defined as the interval from the first day of dasatinib treatment until either (1) there has been a 50% increase in PSA above the treatment nadir, with a minimum of 5ng/mL, or (2) a 25% increase in PSA level above pretreatment levels, with a minimum of 5ng/mL. All PSA-based assessments require a confirmatory level no more than 1 month later. |
| Secondary | Number of Subjects With Dasatinib Toxicity Using Common Terminology Criteria (CTC) (v. 3.0) | From initial date of treatment through study completion, up to 2 years | Due to relatively poor drug tolerance and relatively rapid PSA increases in most patients it was not feasible to continue patients on treatment until there was radiographic evidence of disease progression. |
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 | Number of Subjects With Disease Control (DC) (Based on PSA, Bone Scan, FACT-P, RECIST) | From day 56 (8 weeks) and every 8 weeks thereafter until the date of first documented progression or date of death from any cause, whichever came first, assessed until death, the patient withdraws consent, or the study ends, up to 2 years | 27 subjects were evaluable for response. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Prostate-specific Antigen (PSA) Progression | From initial date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | Data not collected due to relatively poor drug tolerance and relatively rapid PSA increases in most patients as it was not feasible to continue patients on treatment. | ||
| SECONDARY | Number of Subjects With Dasatinib Toxicity Using Common Terminology Criteria (CTC) (v. 3.0) | From initial date of treatment through study completion, up to 2 years | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Number of Subjects With Disease Control (DC) (Based on PSA, Bone Scan, FACT-P, RECIST) | Dasatinib | 5 | Participants | ||
| Number of Subjects With Dasatinib Toxicity Using Common Terminology Criteria (CTC) (v. 3.0) | Dasatinib | 12 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib | 38 | |
| Overall Study | COMPLETED | Dasatinib | 27 | |
| Overall Study | NOT COMPLETED | Dasatinib | 11 |
Source ClinicalTrials.gov
Adverse events22
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 | Anorexia | Psychiatric disorders | Dasatinib | 2 | 38 | |
| other | Decreased Appetite | Psychiatric disorders | Dasatinib | 3 | 38 | |
| other | Elevated Alkaline Phosphatase Levels | Blood and lymphatic system disorders | Dasatinib | 3 | 38 | |
| other | Elevated Amylase | Blood and lymphatic system disorders | Dasatinib | 4 | 38 | |
| other | Elevated Aspartate Aminotransferase Levels | Blood and lymphatic system disorders | Dasatinib | 3 | 38 | |
| other | Elevated lipase levels | Blood and lymphatic system disorders | Dasatinib | 2 | 38 | |
| other | Erythema | Skin and subcutaneous tissue disorders | Dasatinib | 3 | 38 | |
| other | Fatigue | General disorders | Dasatinib | 6 | 38 | |
| other | Diarrhea | Gastrointestinal disorders | Dasatinib | 3 | 38 | |
| other | Nausea | General disorders | Dasatinib | 2 | 38 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib | 8 | 38 |
| Total, other adverse events | Dasatinib | 11 | 38 |
| Total, serious adverse events | Dasatinib | 17 | 38 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23652277 | RESULT |
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/NCT00570700
GET https://conductscience.org/api/trials/v1/NCT00570700/events?page=2