Trial · NCT00580970
Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury
NCT00580970, Phase 2, Completed, Virginia Commonwealth University; results first posted 2016-11-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury. Trials, record NCT00580970. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00580970
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury
- NCT number
- NCT00580970
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 73 participants, actual
- Lead sponsor
- Virginia Commonwealth University
- Conditions
- Prostate Cancer
- Interventions
- lovastatin
- First posted
- 2007-12-27
- Last updated
- 2016-11-18
- Results first posted
- 2016-11-18
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment | 24 months | The primary endpoint of this study was percentage of participants with physician reported rectal toxicity ≥Grade 2 during the first 2 years after treatment. A one sided test will be conducted in order to evaluate reduction of risk from adding Lovastatin. The analysis is using a one-stage design, 5% level of significance, and 83% power. |
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 | Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment | 24 months | The primary endpoint of the study was percentage of participants with physician reported rectal toxicity ≥Grade 2 during the first 2 years after treatment. Only the highest-grade toxicity for each symptom was counted. Symptoms starting in the acute period and unresolved beyond 90 days post treatment are considered late toxicity. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment | Supportive Care (Lovastatin) (Evaluable) | 38 | percentage of participants |
Source ClinicalTrials.gov
Participant flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-treatment | STARTED | Supportive Care (Lovastatin) | 73 | |
| Pre-treatment | COMPLETED | Supportive Care (Lovastatin) | 72 | |
| Pre-treatment | NOT COMPLETED | Supportive Care (Lovastatin) | 1 | |
| Treatment (Lovastatin) | STARTED | Supportive Care (Lovastatin) | 72 | |
| Treatment (Lovastatin) | 6 Months of Treatment | Supportive Care (Lovastatin) | 53 | |
| Treatment (Lovastatin) | COMPLETED | Supportive Care (Lovastatin) | 53 | |
| Treatment (Lovastatin) | NOT COMPLETED | Supportive Care (Lovastatin) | 19 |
Source ClinicalTrials.gov
Adverse events35
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 | Hot flashes/flushes | Endocrine disorders | Supportive Care (Lovastatin) | 5 | 72 | 5 |
| other | Constipation | Gastrointestinal disorders | Supportive Care (Lovastatin) | 12 | 72 | 21 |
| other | Diarrhea | Gastrointestinal disorders | Supportive Care (Lovastatin) | 48 | 72 | 94 |
| other | Flatulence | Gastrointestinal disorders | Supportive Care (Lovastatin) | 48 | 72 | 108 |
| other | Hemorrhage, GI - Anus | Gastrointestinal disorders | Supportive Care (Lovastatin) | 17 | 72 | 29 |
| other | Hemorrhage, GI - Lower GI NOS | Gastrointestinal disorders | Supportive Care (Lovastatin) | 5 | 72 | 6 |
| other | Hemorrhage, GI - Rectum | Gastrointestinal disorders | Supportive Care (Lovastatin) | 9 | 72 | 15 |
| other | Hemorrhoids | Gastrointestinal disorders | Supportive Care (Lovastatin) | 6 | 72 | 8 |
| other | Incontinence, anal | Gastrointestinal disorders | Supportive Care (Lovastatin) | 19 | 72 | 34 |
| other | Nausea | Gastrointestinal disorders | Supportive Care (Lovastatin) | 4 | 72 | 5 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Supportive Care (Lovastatin) | ||
| Total, other adverse events | Supportive Care (Lovastatin) | 70 | 72 |
| Total, serious adverse events | Supportive Care (Lovastatin) | 8 | 72 |
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/NCT00580970
GET https://conductscience.org/api/trials/v1/NCT00580970/events?page=2