Trial Outcomes & Findings for Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury (NCT NCT00580970)
NCT ID: NCT00580970
Last Updated: 2016-11-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
73 participants
Primary outcome timeframe
24 months
Results posted on
2016-11-18
Participant Flow
Recruitment period was between between 2007 to 2013 at Virginia Commonwealth University, Stony Point, Hanover Medical Center, Southside Regional Medical Center, and Hunter Holmes McGuire Veterans Affairs Medical Center (VAMC).
Enrollment period was between April 12, 2007 and May 30, 2013. During that time 73 consecutive subjects enrolled in the study, 72 started treatment. A total of 20 subjects were ineligible for analysis because they did not reach 6 months of Lovastatin treatment, resulting in a total of 53 evaluable subjects.
Participant milestones
| Measure |
Supportive Care (Lovastatin)
Subjects took Lovastatin on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued for 12 months.
73 subjects enrolled in the study, 72 started treatment, 20 subjects were ineligible for analysis, and a total of 53 evaluable subjects.
|
|---|---|
|
Pre-treatment
STARTED
|
73
|
|
Pre-treatment
COMPLETED
|
72
|
|
Pre-treatment
NOT COMPLETED
|
1
|
|
Treatment (Lovastatin)
STARTED
|
72
|
|
Treatment (Lovastatin)
6 Months of Treatment
|
53
|
|
Treatment (Lovastatin)
COMPLETED
|
53
|
|
Treatment (Lovastatin)
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Supportive Care (Lovastatin)
Subjects took Lovastatin on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued for 12 months.
73 subjects enrolled in the study, 72 started treatment, 20 subjects were ineligible for analysis, and a total of 53 evaluable subjects.
|
|---|---|
|
Pre-treatment
Non-compliance
|
1
|
|
Treatment (Lovastatin)
Non-compliance
|
6
|
|
Treatment (Lovastatin)
Intolerance of Lovastatin
|
7
|
|
Treatment (Lovastatin)
Physician Decision
|
4
|
|
Treatment (Lovastatin)
Development of metastatic second primary
|
1
|
|
Treatment (Lovastatin)
Death
|
1
|
Baseline Characteristics
Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury
Baseline characteristics by cohort
| Measure |
Supportive Care (Lovastatin) (Evaluable)
n=53 Participants
The 53 subjects started Lovastatin treatment on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued up to 12 months. The subjects were considered evaluable for analysis because they completed 6 months of Lovastatin.
|
Supportive Care (Lovastatin) (Ineligible)
n=20 Participants
The 20 subjects started Lovastatin on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy). The subjects were ineligible because they did not complete 6 months of Lovastatin.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
58.5 years
n=7 Participants
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
20 participants
n=7 Participants
|
73 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Supportive Care (Lovastatin) (Evaluable)
n=53 Participants
The 53 subjects started Lovastatin treatment on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued up to 12 months. The subjects were considered evaluable for analysis because they completed 6 months of Lovastatin.
|
|---|---|
|
Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment
|
38 percentage of participants
|
Adverse Events
Supportive Care (Lovastatin)
Serious events: 8 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Supportive Care (Lovastatin)
n=72 participants at risk
Subjects who started treatment on Lovastatin on the first day of radiation therapy (external beam radiation therapy (EBRT) alone, brachytherapy alone, or EBRT followed by brachytherapy).
73 subjects enrolled in the study, 72 started Lovastatin treatment, 20 subjects were ineligible for analysis, and a total of 53 subjects evaluable for analysis. 72 subjects started treatment and were at risk for Adverse Events (AEs) and Serious Adverse Events(SAEs).
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.4%
1/72 • Number of events 1 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Cardiac disorders
Cardiac General
|
1.4%
1/72 • Number of events 1 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Gastrointestinal disorders
Gastrointestinal/Proctitis
|
1.4%
1/72 • Number of events 1 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Gastrointestinal disorders
Hemorrhage/Bleeding
|
1.4%
1/72 • Number of events 2 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Gastrointestinal disorders
Hepatobiliary/Pancreas
|
1.4%
1/72 • Number of events 1 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
General disorders
Pain
|
1.4%
1/72 • Number of events 1 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
Other adverse events
| Measure |
Supportive Care (Lovastatin)
n=72 participants at risk
Subjects who started treatment on Lovastatin on the first day of radiation therapy (external beam radiation therapy (EBRT) alone, brachytherapy alone, or EBRT followed by brachytherapy).
73 subjects enrolled in the study, 72 started Lovastatin treatment, 20 subjects were ineligible for analysis, and a total of 53 subjects evaluable for analysis. 72 subjects started treatment and were at risk for Adverse Events (AEs) and Serious Adverse Events(SAEs).
|
|---|---|
|
Endocrine disorders
Hot flashes/flushes
|
6.9%
5/72 • Number of events 5 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Gastrointestinal disorders
Constipation
|
16.7%
12/72 • Number of events 21 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
48/72 • Number of events 94 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Gastrointestinal disorders
Flatulence
|
66.7%
48/72 • Number of events 108 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Gastrointestinal disorders
Hemorrhage, GI - Anus
|
23.6%
17/72 • Number of events 29 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Gastrointestinal disorders
Hemorrhage, GI - Lower GI NOS
|
6.9%
5/72 • Number of events 6 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Gastrointestinal disorders
Hemorrhage, GI - Rectum
|
12.5%
9/72 • Number of events 15 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Gastrointestinal disorders
Hemorrhoids
|
8.3%
6/72 • Number of events 8 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Gastrointestinal disorders
Incontinence, anal
|
26.4%
19/72 • Number of events 34 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Gastrointestinal disorders
Nausea
|
5.6%
4/72 • Number of events 5 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
13.9%
10/72 • Number of events 13 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Gastrointestinal disorders
Proctitis
|
34.7%
25/72 • Number of events 35 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
11.1%
8/72 • Number of events 9 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
8.3%
6/72 • Number of events 10 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
8.3%
6/72 • Number of events 10 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Renal and urinary disorders
Bladder spasms
|
36.1%
26/72 • Number of events 50 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Renal and urinary disorders
Cystitis
|
56.9%
41/72 • Number of events 64 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Renal and urinary disorders
Hemorrhage, GU - Urinary NOS
|
20.8%
15/72 • Number of events 22 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Renal and urinary disorders
Incontinence, urinary
|
45.8%
33/72 • Number of events 75 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Renal and urinary disorders
Dysuria
|
16.7%
12/72 • Number of events 14 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Renal and urinary disorders
Stricture/stenosis (including anastomotic), GU - Prostate
|
8.3%
6/72 • Number of events 13 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
72.2%
52/72 • Number of events 108 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
29.2%
21/72 • Number of events 36 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
11.1%
8/72 • Number of events 8 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Reproductive system and breast disorders
Pain - Penis
|
5.6%
4/72 • Number of events 5 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Reproductive system and breast disorders
Pain - Urethra
|
9.7%
7/72 • Number of events 11 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
|
Renal and urinary disorders
Nocturia
|
6.9%
5/72 • Number of events 9 • 2 years
Systematic Assessments includes medical history, physical exam, Karnofsky Performance Status (KPS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite (EPIC), Common Terminology Criteria for Adverse Events Version 3 (CTCAE), and blood samples (e.g. Lipid profile, CK, CPC, Hepatic panel).
|
Additional Information
Mitchell S. Anscher, M.D. Professor and chairman
Virginia Commonwealth University/Massey Cancer Center
Phone: 804-828-7238
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place