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.

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.

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.

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.

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.

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/Bone Marrow