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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hunter Holmes Mcguire Veteran Affairs Medical Center
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00580970
First received: December 20, 2007
Last updated: October 20, 2015
Last verified: October 2015
  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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:
  • Toxicity to the rectum within the first two years of radiation treatment [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 53
Study Start Date: April 2007
Estimated Study Completion Date: November 2016
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brachytherapy & Lovastatin for 1 yr
Subject begins taking lovastatin on the evening after their radiation implant. They should continue taking 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 each visit they will have their vital signs checked, will be asked about their health since last visit, and will have blood drawn to check their PSA and they will complete the 2 questionnaires. 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 lovaststin. 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
Experimental: Radiation Therapy & Lovastatin for 1 yr
Subject begins taking lovastatin on evening after their first radiation treatment. Continues taking lovastatin once per day for 1 year. The number of radiation therapy treatments will be determined by their radiation oncologist. During radiation therapy, they are checked once per week by radiation oncologist. During this weekly check up, they are asked about side effects, vital signs checked and may have blood drawn. They will fill out the 2 questionnaires again. After radiation treatments, 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 radiation. At each visit vital signs checked,ask about health since their last visit, have blood drawn to check PSA and will complete the 2 questionnaires. At 8 weeks, 4 months, 6 months, 9 months and 12 months, they will also have a blood test to check their liver.
Drug: lovastatin
The HMG-coA reductase inhibitor used in this study will be lovaststin. 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00580970     History of Changes
Other Study ID Numbers: MCC-10802 
Study First Received: December 20, 2007
Last Updated: October 20, 2015
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on February 11, 2016