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Prostate Cancer Prevention Trials


     
Clinical Trial: S0000– SELECT – Selenium and Vitamin E Cancer Prevention
Governing Group: Southwest Oncology Group
Title: “Selenium and Vitamin E Prostate Cancer Prevention Trial (SELECT).”

Eligibility:
  • Participants must be male, age 55 or older (African American men must be age 50 or older).
  • Digital Rectal Exam (DRE) not suspicious for prostate cancer and PSA less than or equal to 4.0 ng/ml, both within 180 days prior to randomization.
  • No prior diagnosis of prostate cancer or high grade PIN.
  • Must not be currently taking any vitamin E or any selenium.
  • Must not be taking any anticoagulation therapy except low dose aspirin.
  • Systolic blood pressure less than 160, diastolic less than 90.
  • No other current clinical trial participation.



Clinical Trial: S9917 – Selenium – Based Prostate Cancer Prevention
Governing Group: Southwest Oncology Group
Title: “L-Selenium-Based Chemoprevention of Prostate Cancer Among Men with High Grade Prostatic Intraepithelial Neoplasia.”

Eligibility:
  • Patients must be age 40 or older.
  • Patients must have had a digital rectal exam (DRE) and biopsy of the prostate with suggested TRUS guidance (required if fewer than six cores obtained) that documents High Grade Prostatic Intrepithelial Neoplasia (High Grade PIN or HGPIN) with no evidence of cancer.
  • The biopsy must either: a.) yielded less than 10 cores within two (2) years prior to registration, or b.) yielded 10 or more cores within six (6) months prior to registration.
  • Patients must have a PSA less than or equal to 10 ng/ml.
  • Patients must have Performance Status of 0 or 1.
  • Patients must agree to stop taking any dietary supplements which contain greater than or equal to 50 mcg/day of selenium within 30 days prior to registration.
  • Patient must agree not to take supplements containing 50 mcg or more of selenium while on study.
  • Patients must not be taking finasteride or any other androgen suppressor.




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