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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00580970
First Posted: December 27, 2007
Last Update Posted: November 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hunter Holmes Mcguire Veteran Affairs Medical Center
Information provided by (Responsible Party):
Virginia Commonwealth University
  Purpose
Lovastatin may protect against late effects of radiation therapy in patients with prostate cancer

Condition Intervention Phase
Prostate Cancer Drug: lovastatin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Phase II Study to Prevent Radiation-Induced Rectal Injury With Lovastatin

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment [ Time Frame: 24 months ]
    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.


Enrollment: 73
Study Start Date: April 2007
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lovastatin for 1 yr
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.
Other Names:
  • Altoprev
  • Mevacor

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580970


Locations
United States, Virginia
Hunter Holmes McGuire Veterans Administration Medical Center
Richmond, Virginia, United States, 23249
Massey Cancer Center/Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Southside Regional Medical Center
Richmond, Virginia, United States, 23805
Sponsors and Collaborators
Virginia Commonwealth University
Hunter Holmes Mcguire Veteran Affairs Medical Center
Investigators
Principal Investigator: Mitchell S. Anscher, MD Massey Cancer Center
  More Information

Additional Information:
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00580970     History of Changes
Other Study ID Numbers: MCC-10802
NCI-2011-01676 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: December 20, 2007
First Posted: December 27, 2007
Results First Submitted: June 3, 2016
Results First Posted: November 18, 2016
Last Update Posted: November 18, 2016
Last Verified: September 2016

Keywords provided by Virginia Commonwealth University:
prostate cancer
radiation therapy
lovastatin
rectal injury

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Lovastatin
L 647318
Dihydromevinolin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors