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

This study is currently recruiting participants.

Verified by Virginia Commonwealth University, March 2009

First Received: December 20, 2007 Last Updated: March 6, 2009 History of Changes

Sponsors and Collaborators:	Virginia Commonwealth University Hunter Holmes Mcguire Veteran Affairs Medical Center
Information provided by:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00580970

Purpose

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

Condition	Intervention	Phase
Prostate Cancer	Drug: lovastatin	Phase II

MedlinePlus related topics: Cancer Prostate Cancer Radiation Therapy

Drug Information available for: Lovastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Phase II Study to Prevent Radiation-Induced Rectal Injury With Lovastatin

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:

Toxicity to the rectum toxicity within the first two years of radiation treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	53
Study Start Date:	April 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Lovastatin + radiation therapy	Drug: lovastatin 20 mg/day for 12 months

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 day of brachytherapy (brachytherapy alone or brachytherapy followed by external beam radiotherapy) and continue for 12 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580970

Contacts

Contact: Mitchell S. Anscher, MD	804-828-7238	msanscher@vcu.edu
Contact: Diane J. Holdford, RN	804-828-0296	djholdfo@vcu.edu

Locations

United States, Virginia
Massey Cancer Center/Virginia Commonwealth University	Recruiting
Richmond, Virginia, United States, 23298
Principal Investigator: Mitchell S. Anscher, MD

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:

Massey Cancer Center Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Massey Cancer Center/Virginia Commonwealth University ( Mitchell Ancsher, MD )
Study ID Numbers:	MCC-10802
Study First Received:	December 20, 2007
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00580970 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:

prostate cancer
radiation therapy
lovastatin
rectal injury

Study placed in the following topic categories:

Antimetabolites
Prostatic Diseases
Genital Neoplasms, Male
Antilipemic Agents
Urogenital Neoplasms

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Genital Diseases, Male
Prostatic Neoplasms
Lovastatin

Additional relevant MeSH terms:

Antimetabolites
Genital Neoplasms, Male
Prostatic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Urogenital Neoplasms
Anticholesteremic Agents

Genital Diseases, Male
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms
Lovastatin

ClinicalTrials.gov processed this record on May 07, 2009