Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Hematinics

All Drugs and Chemicals

Lipid Regulating Agents

Liver Extracts

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Lovastatin

L 647318

Dihydromevinolin

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Enzyme Inhibitors

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.

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.

lovastatin

Mitchell S. Anscher, MD

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.

Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury

A Phase II Study to Prevent Radiation-Induced Rectal Injury With Lovastatin

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.

Hunter Holmes Mcguire Veteran Affairs Medical Center

Virginia Commonwealth University

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).

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).

Supportive Care (Lovastatin)

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) (Evaluable)

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.

Supportive Care (Lovastatin) (Ineligible)

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

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.

Mitchell S. Anscher, M.D. Professor and chairman

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 With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury	NCT00580970	Prostate Cancer	lovastatin	18 Years -	Virginia Commonwealth University
Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury	NCT00580970	Prostate Cancer	lovastatin	18 Years -	Virginia Commonwealth University

Spots Global Cancer Trial Database for rectal injury