The toremifene/PIN trial has been designed to assess the potential of toremifene in preventing the progression of prostatic intraepithelial neoplasia (PIN) to active prostate cancer in men with a diagnosis of high grade PIN.
The study is a randomized double-blind, placebo-controlled study and was started in 2005 and has recruited a full complement of 1,590 participants. Participants are randomized to receive either toremifene 20 mg (the study drug) or placebo once daily for 36 months. They will receive regular assessment for effectiveness and safety on a predetermined schedule. It is projected that this trial will be completed some time in 2010.
Key inclusion criteria for eligibility in this trial were:
- Being male, and aged ≥ 30 years
- Having a diagnosis of high grade PIN from any previous prostate biopsy (as confirmed by the central study pathologist )
- Having had a prostate biopsy in the last 6 months that shows no evidence of cancer OR having had two prostate biopsies in the 12 months prior to screening that showed no evidence of cancer with at least one of the biopsies occurring within 6 months prior to the screening visit
- Have a serum PSA of ≤ 10 ng/mL
- Have adequate bone marrow, liver and renal function according to the trial protocol
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