Trial · NCT00121238
Cilengitide in Treating Patients With Prostate Cancer
NCT00121238, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2016-04-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cilengitide in Treating Patients With Prostate Cancer. Trials, record NCT00121238. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00121238
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cilengitide in Treating Patients With Prostate Cancer
- NCT number
- NCT00121238
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer
- Interventions
- cilengitide
- First posted
- 2005-07-21
- Last updated
- 2016-04-28
- Results first posted
- 2016-04-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Patients With a PSA Decline of ≥50% | Up to 5 years | To assess the rate of Prostate Specific Antigen response associated with EMD121974 therapy in patients with non-metastatic androgen-independent prostate cancer. This measure defined as a drop in PSA of at least 50% from the final pre-treatment value. |
| Secondary | Median PSA Slope Difference | Baseline to 6 months | Median PSA slope difference was calculated between baseline and 6 months. |
| Secondary | The Number of Participants With at Least One Incident of Toxicity | Up to 5 years | Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients (16 patients were enrolled however one progressed prior to treatment) including the two ineligible patients. |
| Secondary | Median Survival Time | Up to 5 years | 6 of 13 patients were alive at five years. The Median survival time was calculated for all patients. |
| Secondary | Mean Time to Progression of Prostate Cancer | Up to 5 years | Kaplan-Meier estimates of time to progression will be reported. |
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 | The Number of Patients With a PSA Decline of ≥50% | Up to 5 years | Per protocol: of the 16 patients registered for this arm, 13 were analyzed. 1 patient lost eligibility due to disease progression, 2 others were censored from efficacy analysis because it was determined they were ineligible based on PSA requirements. | participants | NUMBER |
| SECONDARY | Median PSA Slope Difference | Baseline to 6 months | ng/mL/month | MEDIAN | |
| SECONDARY | The Number of Participants With at Least One Incident of Toxicity | Up to 5 years | All treated patients, including 2 patients who were deemed ineligible for the study's endpoints to measure efficacy. | participants | NUMBER |
| SECONDARY | Median Survival Time | Up to 5 years | months | MEDIAN | |
| SECONDARY | Mean Time to Progression of Prostate Cancer | Up to 5 years | Patients were eligible if they had a histologic or cytologic diagnosis of prostate cancer with no evidence of metastatic disease or local progression on radiologic imaging and had 3 consecutive rising levels of prostate specific antigen (psa). Eligible patients who were treated on this trial were analyzed for survival | months | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Patients With a PSA Decline of ≥50% | Drug Treatment (Cilengitide) | 0 | participants | ||
| Median PSA Slope Difference | Drug Treatment (Cilengitide) | 0.9 | Inter-Quartile Range -0.97 to 4.11 | ng/mL/month | |
| The Number of Participants With at Least One Incident of Toxicity | Drug Treatment (Cilengitide) | 15 | participants | ||
| Median Survival Time | Drug Treatment (Cilengitide) | 34.5 | 95% Confidence Interval 27.4 to NA | months | |
| Mean Time to Progression of Prostate Cancer | Drug Treatment (Cilengitide) | 1.8 | 95% Confidence Interval 0.9 to 2.8 | 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 | Drug Treatment (Cilengitide) | 16 | |
| Overall Study | COMPLETED | Drug Treatment (Cilengitide) | 13 | |
| Overall Study | NOT COMPLETED | Drug Treatment (Cilengitide) | 3 |
Source ClinicalTrials.gov
Adverse events21
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 | Arthritis (Gr1) | Musculoskeletal and connective tissue disorders | Drug Treatment (Cilengitide) | 2 | 15 | |
| other | Increased aspartate aminotransferase (Gr1) | Blood and lymphatic system disorders | Drug Treatment (Cilengitide) | 1 | 15 | |
| other | Constipation (Gr1) | Gastrointestinal disorders | Drug Treatment (Cilengitide) | 1 | 15 | |
| other | Diarrhea (Gr1) | Gastrointestinal disorders | Drug Treatment (Cilengitide) | 1 | 15 | |
| other | Dry eye syndrome (Gr1) | Eye disorders | Drug Treatment (Cilengitide) | 1 | 15 | |
| other | Edema (Gr.1) | General disorders | Drug Treatment (Cilengitide) | 1 | 15 | |
| other | Fatigue (Gr.1) | General disorders | Drug Treatment (Cilengitide) | 4 | 15 | |
| other | Flushing (Gr1) | General disorders | Drug Treatment (Cilengitide) | 1 | 15 | |
| other | Headache (Gr.1) | General disorders | Drug Treatment (Cilengitide) | 1 | 15 | |
| other | Decreased hemoglobin (gr1) | Blood and lymphatic system disorders | Drug Treatment (Cilengitide) | 2 | 15 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Drug Treatment (Cilengitide) | ||
| Total, other adverse events | Drug Treatment (Cilengitide) | 15 | 15 |
| Total, serious adverse events | Drug Treatment (Cilengitide) | 2 | 15 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21049281 | 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/NCT00121238
GET https://conductscience.org/api/trials/v1/NCT00121238/events?page=2