Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: eflornithine; Placebo
Intervention description: Take 500mg of DFMO per day for 12 months; Take placebo per day for 12 months
Intervention MeSH terms: Eflornithine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 76.0
Sex: Male
Minimum age: 35 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: stage I prostate cancer

Summary:

      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development of cancer. The use of eflornithine (DMFO) may be an effective way to prevent the
      development of prostate cancer.

      PURPOSE: Randomized phase II trial to determine the effectiveness of eflornithine in
      preventing prostate cancer in patients who are at high risk of developing the disease.
    

Eligibility criteria:

        Criteria for Eligibility

          1. Men between the ages of 35 and 70 with family history of prostate cancer, i.e.,
             prostate cancer diagnosed in two first degree relatives before the age of 70 years.
             (First degree relatives include a brother, father, and son.) There will be occasions
             in which a second or even third degree relative will be eligible. Additional
             information regarding these criteria is provided below and in Attachment 1.)

               -  Two or more affected relatives of which at least 1 is a first degree relative or

               -  At least two affected relatives, both of which are at least a second degree
                  relative or

               -  One first degree relative diagnosed with prostate cancer at age 55 or less.

          2. No history of invasive cancer within 5 years (though non-melanoma skin or papillary
             bladder cancer will not be reason to exclude a patient); no prior history of prostate
             cancer, no severe metabolic disorders or other life-threatening acute or chronic
             disease; no additional x-ray or chemotherapy anticipated.

               -  Men found to have localized prostate cancer (Gleason score ≤7) as part of the
                  screening for the current trial, and opt for watchful waiting as their standard
                  of care treatment for their condition, will be eligible to sign an additional
                  consent form to continue with the randomization and on-study activities of this
                  trial. On-study activities for these individuals will not differ from the
                  on-study activities for the other men enrolled in this trial.

          3. Must not require a medically mandated special diet which precludes compliance with
             study requirements

          4. Not requiring regular use of anticoagulants on a regular basis. Prior use of
             chemoprevention agent(s) (such as Proscar) is allowed as long as the subject has been
             off the agent(s) for at least 3 months. Not currently participating in another
             prostate prevention trial.

          5. Absence of history of current documented or symptomatic gastric or duodenal ulcer
             within 12 months prior to study entry, or of significant kidney or liver disease. No
             chronic anemia (hematocrit < 35 volume %), leukopenia (WEB <4,000) with normal
             differential, or thrombocytopenia (platelets <100,000) and with serum creatinine <1.5
             mg/dl, serum bilirubin <2.0 mg/dl, and serum glutamic oxaloacetic transaminase (SGOT)
             or serum glutamic pyruvic transaminase (SGPT) <2× normal. Urinalysis should have <1+
             protein, 0-3 casts, 0-5 white blood cell count (WBC) and red blood cell count (RBC).

          6. Absence of any condition that predisposes to difficulties with hearing, wound healing
             or repair.

          7. Must meet Southwest Oncology Group performance status criteria of 0-1 (0 = fully
             active, able to carry on all predisease activities without restriction [Karnofsky
             scale 90-100]; 1 = restricted in physically strenuous activity, but ambulatory and
             able to carry out work of a light or sedentary nature, i.e., light housework or office
             work [Karnofsky scale 70-80].

          8. Subjects must be willing and able to keep required visits for study procedures and to
             complete study questionnaires.

          9. Patient must not have had radiation therapy in the pelvic area.