Trial · NCT00488982
Intermittent Chemotherapy With or Without Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) for Metastatic Hormone Refractory Prostate Cancer (HRPC)
NCT00488982, Phase 2, Completed, University of California, San Francisco; results first posted 2019-11-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intermittent Chemotherapy With or Without Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) for Metastatic Hormone Refractory Prostate Cancer (HRPC). Trials, record NCT00488982. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00488982
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intermittent Chemotherapy With or Without Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) for Metastatic Hormone Refractory Prostate Cancer (HRPC)
- NCT number
- NCT00488982
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 125 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Prostate Cancer
- Interventions
- Docetaxel, Docetaxel and GM-CSF
- First posted
- 2007-06-20
- Last updated
- 2019-11-20
- Results first posted
- 2019-11-20
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Progression | Up to 7 years | The Kaplan-Meier product limit method with 95% confidence intervals will be used to estimate the median time to disease progression during initial course of randomized treatment |
| Secondary | Overall Survival | Up to 7 years | The Kaplan-Meier product limit method will be used to estimate the median overall survival |
| Secondary | Number of Participants With PSA Response to Successive Series of Chemotherapy | Up to 6 years | PSA partial response is defined by at least a 50% decline from PSA value from the baseline measurement to 12 weeks of protocol therapy. The decline must be confirmed by a second PSA value obtained 4 or more weeks later For those patients whose PSA have decreased but has not reached response criteria defined above, progressive disease is defined as 25% increase over the nadir PSA value provided that the increase is at least 5ng/mL and is confirmed. |
| Secondary | Cumulative Duration of Time on and Off Docetaxel-based Therapy | Up to 7 years | Median percentage of time will be calculated to summarize the total duration of chemotherapy and amount of docetaxel/prednisone administered while the patient is on study. The same results will be tabulated for each. For the on-chemotherapy period: will be estimated from the date of starting protocol therapy; if a patient received docetaxel on day 2 of a cycle, he will be considered to have received a full 21 days on therapy. For the off-chemotherapy period: will be calculated from the date of starting the observation or GM-CSF period to the date of resuming chemotherapy |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Progression | Up to 7 years | months | MEDIAN | |
| SECONDARY | Overall Survival | Up to 7 years | months | MEDIAN | |
| SECONDARY | Number of Participants With PSA Response to Successive Series of Chemotherapy | Up to 6 years | Twenty-six participants total resumed a second course of the Docetaxel, and five participants went on to resume a third course of treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cumulative Duration of Time on and Off Docetaxel-based Therapy | Up to 7 years | months | MEDIAN |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Progression | Docetaxel and Observation | 1.5 | 95% Confidence Interval 1.5 to 2.4 | months | |
| Time to Progression | Docetaxel and GM-CSF | 3.3 | 95% Confidence Interval 2.4 to 3.5 | months | |
| Overall Survival | Docetaxel and Observation | 14 | 95% Confidence Interval 10.5 to 27.6 | months | |
| Overall Survival | Docetaxel and GM-CSF | 28.4 | 95% Confidence Interval 19.2 to 34.1 | months | |
| Overall Survival | Overall Survival | 15.6 | 95% Confidence Interval 13.1 to 18.8 | months | |
| Number of Participants With PSA Response to Successive Series of Chemotherapy | Docetaxel and Observation | PSA response to Course 2 chemotherapy | 4 | Participants | |
| Number of Participants With PSA Response to Successive Series of Chemotherapy | Docetaxel and GM-CSF | PSA response to Course 2 chemotherapy | 8 | Participants | |
| Number of Participants With PSA Response to Successive Series of Chemotherapy | Docetaxel and Observation | PSA response to Course 3 chemotherapy | 1 | Participants | |
| Number of Participants With PSA Response to Successive Series of Chemotherapy | Docetaxel and GM-CSF | PSA response to Course 3 chemotherapy | 0 | Participants | |
| Cumulative Duration of Time on and Off Docetaxel-based Therapy | Docetaxel and Observation OFF Chemotherapy | 24.7 | 95% Confidence Interval 0.8 to 50.8 | months |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow51
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Chemotherapy | STARTED | Pre-Randomization | 125 | |
| Induction Chemotherapy | STARTED | Docetaxel and Observation | 0 | |
| Induction Chemotherapy | STARTED | Docetaxel and GM-CSF | 0 | |
| Induction Chemotherapy | 6 Cycles Completed | Pre-Randomization | 94 | |
| Induction Chemotherapy | 6 Cycles Completed | Docetaxel and Observation | 0 | |
| Induction Chemotherapy | 6 Cycles Completed | Docetaxel and GM-CSF | 0 | |
| Induction Chemotherapy | ≥ 50% Prostate-specific Antigen Decline | Pre-Randomization | 52 | |
| Induction Chemotherapy | ≥ 50% Prostate-specific Antigen Decline | Docetaxel and Observation | 0 | |
| Induction Chemotherapy | ≥ 50% Prostate-specific Antigen Decline | Docetaxel and GM-CSF | 0 | |
| Induction Chemotherapy | COMPLETED | Pre-Randomization | 52 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 participant flowAdverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Febrile neutropenia | Infections and infestations | All Accrued Patients | 8 | 125 | 9 |
| serious | Neutropenia | Infections and infestations | All Accrued Patients | 12 | 125 | 14 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Accrued Patients | 8 | 125 |
| Total, other adverse events | All Accrued Patients | 0 | 125 |
| Total, serious adverse events | All Accrued Patients | 20 | 125 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00488982
GET https://conductscience.org/api/trials/v1/NCT00488982/flow?page=2