A Phase 2 interventional study of lovastatin in Prostate Cancer, sponsored by Virginia Commonwealth University. Completed at 3 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-18.
Sponsored by Virginia Commonwealth University · Phase 2, Interventional, and Supportive care
Lovastatin may protect against late effects of radiation therapy in patients with prostate cancer
Oral lovastatin will be given at the dose of 20 mg/day with evening meal beginning on the first day of external beam radiation therapy (external beam alone or external beam followed by brachytherapy) or on the first day of brachytherapy (brachytherapy alone or brachytherapy followed by external beam radiotherapy) and continue for 12 months.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 73 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Lovastatin (20-80 mg/d) was started on day 1 of radiation and continued for 12 months. Patients were followed for an additional 12 months. Lovastatin once per day for 1 year. After the implant, they are asked to return for checkups (study visits 4-13) 4 weeks, 8 weeks, 4 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months and 24 months after the procedure. At 8 weeks, 4 months, 6 months, 9 months and 12 months, will also have a blood test to check their liver.
Drug: lovastatin
The HMG-coA reductase inhibitor used in this study will be lovastatin. Dosage: 20 mg/d PO with evening meal. Patients on a higher dose of lovastatin at the time of study entry may continue at that dose level; for patients switching to lovastatin, the dose will be at the discretion of the prescribing physician, but must be at least 20 mg/day.Schedule: begin on the first day of external beam radiation therapy (external beam alone or external beam followed by brachytherapy) or on the day of brachytherapy (brachytherapy alone or brachytherapy followed by external beam radiotherapy) and continue for 12 months. Patients or their third party payers will be expected to cover the cost of the drug.
Also known as: Altoprev, Mevacor
Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment
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.
Time frame: 24 months
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).
| Milestone | Supportive Care (Lovastatin) |
|---|---|
| Started | 73 |
| Completed | 72 |
| Not completed | 1 |
| Withdrew: Non-compliance | 1 |
| Milestone | Supportive Care (Lovastatin) |
|---|---|
| Started | 72 |
| 6 months of treatment | 53 |
| Completed | 53 |
| Not completed | 19 |
| Withdrew: Non-compliance | 6 |
| Withdrew: Intolerance of lovastatin | 7 |
| Withdrew: Physician decision | 4 |
| Withdrew: Development of metastatic second primary | 1 |
| Withdrew: Death | 1 |
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.
| percentage of participants | Supportive Care (Lovastatin) (Evaluable) |
|---|---|
| Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment | 38 |
Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Supportive Care (Lovastatin) | — | 8/72 (11.1%) | 70/72 (97.2%) |
| Event | Supportive Care (Lovastatin) |
|---|---|
| HemoglobinBlood and lymphatic system disorders | 1/72 |
| Cardiac GeneralCardiac disorders | 1/72 |
| Gastrointestinal/ProctitisGastrointestinal disorders | 1/72 |
| Hemorrhage/BleedingGastrointestinal disorders | 1/72 |
| Hemorrhage/BleedingGastrointestinal disorders | 1/72 |
| Hemorrhage/BleedingGastrointestinal disorders | 1/72 |
| Hepatobiliary/PancreasGastrointestinal disorders | 1/72 |
| PainGeneral disorders | 1/72 |
| Event | Supportive Care (Lovastatin) |
|---|---|
| Urinary frequency/urgencyRenal and urinary disorders | 52/72 |
| DiarrheaGastrointestinal disorders | 48/72 |
| FlatulenceGastrointestinal disorders | 48/72 |
| CystitisRenal and urinary disorders | 41/72 |
| Incontinence, urinaryRenal and urinary disorders | 33/72 |
| Bladder spasmsRenal and urinary disorders | 26/72 |
| ProctitisGastrointestinal disorders | 25/72 |
| Urinary retention (including neurogenic bladder)Renal and urinary disorders | 21/72 |
| Incontinence, analGastrointestinal disorders | 19/72 |
| Hemorrhage, GI - AnusGastrointestinal disorders | 17/72 |
Between April 12, 2007 and May 30, 2013, 73 consecutive patients enrolled in the study. A total of 20 patients did not complete at least 6 months of Lovastatin treatment and were deemed ineligible for the purpose of assessing late rectal toxicity and additional patients were enrolled in order to achieve the accrual goal of 53 evaluable patients.
| Age, Continuous(years) | Supportive Care (Lovastatin) (Evaluable) | Supportive Care (Lovastatin) (Ineligible) | Total |
|---|---|---|---|
| Median | 63 (47 to 80) | 58.5 (50 to 69) | 62 (47 to 80) |
| Sex: Female, Male(Participants) | Supportive Care (Lovastatin) (Evaluable) | Supportive Care (Lovastatin) (Ineligible) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 53 | 20 | 73 |
| Race (NIH/OMB)(Participants) | Supportive Care (Lovastatin) (Evaluable) | Supportive Care (Lovastatin) (Ineligible) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 22 | 10 | 32 |
| White | 31 | 10 | 41 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Supportive Care (Lovastatin) (Evaluable) | Supportive Care (Lovastatin) (Ineligible) | Total |
|---|---|---|---|
| United States | 53 | 20 | 73 |
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Virginia Commonwealth University