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

NCT00580970 | Completed Phase 2 Results DMC

• 2 other identifiers: MCC-10802NCI-2011-01676
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 3

Brief Summary

Lovastatin may protect against late effects of radiation therapy in patients with prostate cancer

Conditions

Prostate Cancer

Keywords

prostate cancer; radiation therapy; lovastatin; rectal injury

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Study Arms (1)

Lovastatin for 1 yr

EXPERIMENTAL

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

Interventions

lovastatin DRUG

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

Lovastatin for 1 yr

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
• Planned treatment with radiation therapy to include external beam and/or brachytherapy with curative intent (total dose ≥60 Gy). A portion of the rectum must receive at least 60 Gy.
• Age at least 18 years
• Karnofsky Performance Status (KPS) ≥ 70
• No history of prior radiotherapy to the prostate or rectum
• History of prior malignancy, if likely to live at least 4 years, is acceptable.
• No evidence of distant metastases
• Patients may be taking an HMG-coA-reductase inhibitor, but to be eligible, they must be able to be changed to lovastatin 20 mg/day, with the permission of their prescribing physician.
• Creatine kinase \< 5 times upper normal limit
• Sufficient renal function defined as calculated creatinine clearance ≥ 30ml/min
• transaminases \< 3 times upper normal limit

You may not qualify if:

• Planned abdomino-perineal resection after radiotherapy
• Contraindication to an HMG-coA-reductase inhibitor
• Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
• Currently taking an inhibitor of cytochrome P450 3A4
• Active liver or muscle disease

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Hunter Holmes Mcguire Veteran Affairs Medical Center: collaborator

Study Sites (3)

Hunter Holmes McGuire Veterans Administration Medical Center

Richmond, Virginia, 23249, United States

Location

Massey Cancer Center/Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Southside Regional Medical Center

Richmond, Virginia, 23805, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lovastatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Mitchell S. Anscher, M.D. Professor and chairman
• Organization: Virginia Commonwealth University/Massey Cancer Center

mitchell.anscher@vcuhealth.org

804-828-7238

Study Officials

• Mitchell S. Anscher, MD

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 27, 2007
• Study Start: April 1, 2007
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 18, 2016
• Results First Posted: November 18, 2016

Record last verified: 2016-09

Locations

US (3)