Trial · NCT00118092
17-AAG in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy
NCT00118092, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-02-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 17-AAG in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy. Trials, record NCT00118092. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00118092
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 17-AAG in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy
- NCT number
- NCT00118092
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer
- Interventions
- tanespimycin, laboratory biomarker analysis
- First posted
- 2005-07-11
- Last updated
- 2017-04-18
- Results first posted
- 2017-02-20
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PSA Response as Defined by the Recommendations of the Prostate-Specific Antigen Working Group | Up to 1 year | Normalization: PSA ≤4.0 ng/ml. This must be confirmed by a second PSA value measured when patient returns in 4-6 weeks. This qualifies as a CR response. \> \> 50% decline: A 50% decline in PSA value from baseline which must be confirmed by a second PSA value measured when patient returns in 4-6 weeks later. This qualifies as a PR response.\> \> Progression: A 25% or greater increase over baseline and an increase in the PSA level by at least 5 ng/mL, which is confirmed by a second value obtained approximately one week later. In addition, radiographic scans are required to confirm that a disease progression is by PSA only. |
| Secondary | Proportion of Overall Responses | Up to 3 years | Confirmed response rate was defined using Response Evaluation Criteria In Solid Tumors (RECIST). A confirmed response is defined as a complete response (CR) or partial response (PR) observed on subsequent scans at least 4 weeks apart. Confirmed response rate was estimated by the number of successes divided by the total number of evaluable patients. Complete Response (CR) is defined as the disappearance of all target lesions. Partial Response (PR) is defined as a 30% decrease in sum of longest diameter of target lesions. The proportion of confirmed responses will be estimated by the number of patients with confirmed responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. |
| Secondary | Overall Survival | From registration to death due to any cause, assessed up to 3 years | Overall survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. |
| Secondary | Disease-free Survival | From registration to documentation of disease progression, assessed up to 3 years | Disease-free survival time is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had progressed at the time of their death. In patients who have achieved a PSA response, we will assess the time to PSA progression. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on day 1 post-registration. The distribution of disease-free survival time will be estimated using the method of Kaplan-Meier. |
| Secondary | Duration of PSA Response and PSA Control | From PSA response to time of progression, assessed up to 1 year | The distribution of this response duration will be estimated using the method of Kaplan-Meier. In patients whose PSA has declined from baseline by at least 30 %, "duration of PSA response" will be defined as the time from PSA response to time of progression. If a patient goes on to alternate therapy, they will be censored at the date they end treatment on this study. "Duration of PSA Control" is defined as the time from the date of the first 30% decline in PSA until an inflection point is identified. Inflection point is defined as the time to first consistent PSA increase, the point at which PSA began what becomes a continuous increase \> (retrospectively identified). The inflection point is the point at which disease control could assume to be lost. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | PSA Response as Defined by the Recommendations of the Prostate-Specific Antigen Working Group | Up to 1 year | All 15 eligible patients that started treatment were evaluated. | participants | NUMBER |
| SECONDARY | Proportion of Overall Responses | Up to 3 years | All 15 eligible patients that started treatment were evaluated. | percentage of responses | NUMBER |
| SECONDARY | Overall Survival | From registration to death due to any cause, assessed up to 3 years | All 15 eligible patients that started treatment were evaluated. | months | MEDIAN |
| SECONDARY | Disease-free Survival | From registration to documentation of disease progression, assessed up to 3 years | All 15 eligible patients that started treatment were evaluated. | months | MEDIAN |
| SECONDARY | Duration of PSA Response and PSA Control | From PSA response to time of progression, assessed up to 1 year | No participants with PSA response or PSA control. |
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 |
|---|---|---|---|---|---|
| PSA Response as Defined by the Recommendations of the Prostate-Specific Antigen Working Group | Treatment (Tanespimycin) | 0 | participants | ||
| Proportion of Overall Responses | Treatment (Tanespimycin) | 0 | 95% Confidence Interval 0 to 22 | percentage of responses | |
| Overall Survival | Treatment (Tanespimycin) | 9.4 | 95% Confidence Interval 2.7 to 17.7 | months | |
| Disease-free Survival | Treatment (Tanespimycin) | 1.8 | 95% Confidence Interval 1.3 to 3.4 | months |
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 | Treatment (Tanespimycin) | 17 | |
| Overall Study | COMPLETED | Treatment (Tanespimycin) | 15 | |
| Overall Study | NOT COMPLETED | Treatment (Tanespimycin) | 2 |
Source ClinicalTrials.gov
Adverse events52
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 | Hemoglobin decreased | Blood and lymphatic system disorders | Treatment (Tanespimycin) | 14 | 17 | 19 |
| other | Premature ventricular contractions | Cardiac disorders | Treatment (Tanespimycin) | 1 | 17 | 2 |
| other | Sinus arrhythmia | Cardiac disorders | Treatment (Tanespimycin) | 1 | 17 | 1 |
| other | Sinus bradycardia | Cardiac disorders | Treatment (Tanespimycin) | 1 | 17 | 1 |
| other | Supraventricular extrasystoles | Cardiac disorders | Treatment (Tanespimycin) | 3 | 17 | 4 |
| other | Vision blurred | Eye disorders | Treatment (Tanespimycin) | 1 | 17 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Tanespimycin) | 3 | 17 | 4 |
| other | Constipation | Gastrointestinal disorders | Treatment (Tanespimycin) | 4 | 17 | 4 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Tanespimycin) | 6 | 17 | 6 |
| other | Flatulence | Gastrointestinal disorders | Treatment (Tanespimycin) | 1 | 17 | 1 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Tanespimycin) | ||
| Total, other adverse events | Treatment (Tanespimycin) | 16 | 17 |
| Total, serious adverse events | Treatment (Tanespimycin) | 2 | 17 |
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/NCT00118092
GET https://conductscience.org/api/trials/v1/NCT00118092/events?page=2