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A Phase II Study to Prevent Radiation-Induced Rectal Injury With Lovastatin


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

A Phase II Study to Prevent Radiation-Induced Rectal Injury With Lovastatin


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Toxicity to the rectum within the first two years of radiation treatment

Outcome Time Frame:

24 months

Safety Issue:

Yes

Principal Investigator

Mitchell S. Anscher, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massey Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

MCC-10802

NCT ID:

NCT00580970

Start Date:

April 2007

Completion Date:

September 2015

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • radiation therapy
  • lovastatin
  • rectal injury
  • Prostatic Neoplasms

Name

Location

Massey Cancer Center/Virginia Commonwealth UniversityRichmond, Virginia  23298
Hunter Holmes McGuire Veterans Administration Medical CenterRichmond, Virginia  23249
Southside Regional Medical CenterRichmond, Virginia  23805