{
"info": {
"nct_id": "NCT00106691",
"official_title": "A Randomized, Double-Blind, Placebo-Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate for the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia (PIN)",
"inclusion_criteria": "* Give voluntary signed informed consent in accordance with institutional policies\n* Be male, aged ≥ 30 years\n* Have a diagnosis of high grade PIN from any previous prostate biopsy. The diagnosis of high grade PIN must be confirmed by the central pathologist\n* Have had a prostate biopsy in the last 6 months with a minimum of 10 cores that shows no evidence of cancer as confirmed by the central pathologist; OR, have had 2 prostate biopsies (each with a minimum of 6 cores) in the 12 months prior to screening with at least one of the biopsies occurring within 6 months prior to the screening visit. Both biopsies should have no evidence of cancer as confirmed by the central pathologist\n* Have a serum PSA of ≤ 10 ng/mL\n* Agree to provide tablet containers for tablet counts and to complete a daily diary of study drug intake\n* Agree to use an effective method of contraception, if the partner is of child-bearing age, while on study and for 30 days after the last dose of study medication\n* Have adequate bone marrow, liver and renal function:\n\n * White Blood Cell (WBC) Count ≥ 3,000/mm3;\n * Platelet Count ≥ 100,000/mm3;\n * Bilirubin ≤ 1.5 mg/dL;\n * AST and ALT < 2x upper limit of normal;\n * Serum Creatinine ≤ 2.0 mg%\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 30 Years",
"exclusion_criteria": "* Previous exposure to toremifene citrate\n* Have evidence of prostate cancer (local, regional and/or distal metastasis)\n* Have any history of other malignancies (Exceptions include non-melanoma skin cancer or other cancer that has no evidence of tumor reoccurrence 5 years after definitive treatment).\n* Have active systemic viral, bacterial, or fungal infections requiring treatment\n* Have, in the judgment of the investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol\n* Concurrently being treated with other investigational agents or have participated in an investigational study within 60 days prior to screening\n* Currently taking dutasteride. Subject is eligible if he stops dutasteride for a total washout of 90 days prior to the Screening Visit and agrees not to use dutasteride for the duration of the study.\n* Have previously taken finasteride for greater than two years\n* Currently taking finasteride. Subject is eligible if he stops finasteride for a total washout of 30 days prior to the Screening Visit and agrees not to use finasteride for the duration of the study.\n* Currently taking testosterone or testosterone-like supplements, such as dehydroepiandrosterone (DHEA). Subject is eligible if he stops these agents for a total washout of 30 days prior to the Screening Visit and agrees not to use these agents for the duration of the study.\n* Have a history of taking PC-SPES within the past two years.\n* Currently taking herbal medicine or dietary supplements for prostate health, such as Saw Palmetto (also known as Serenoa Repens).\n\nSubject is eligible if he stops these agents for a total washout of 30 days prior to taking the first dose of study drug and agrees not to use these agents for the duration of the study.\n\nLycopene, vitamin E and selenium are not prohibited and no washout is required. However, vitamin E intake should be limited to less than 400 i.u. per day.\n\n* Have a history of thromboembolic event or disease including deep vein thrombosis, pulmonary embolus, or thrombotic stroke\n* History of chronic hepatitis or cirrhosis",
"miscellaneous_criteria": ""
},
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"criterion": "informed consent",
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"expected_value": true
}
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}
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"and_criteria": [
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"operator": "<=",
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"unit": "months"
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"line": "* Serum Creatinine ≤ 2.0 mg%",
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"exact_snippets": "Serum Creatinine ≤ 2.0 mg%",
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},
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}
},
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}
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}
},
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"identified_line": {
"line": "* Agree to provide tablet containers for tablet counts and to complete a daily diary of study drug intake",
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"line": "* Previous exposure to toremifene citrate",
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"exact_snippets": "Previous exposure to toremifene citrate",
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}
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},
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"criterions": [
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}
},
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}
},
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{
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"exact_snippets": "Subject is eligible if he stops finasteride for a total washout of 30 days prior to the Screening Visit",
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"requirement_type": "duration",
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"operator": ">=",
"value": 30,
"unit": "days"
}
}
},
{
"exact_snippets": "agrees not to use finasteride for the duration of the study",
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"requirement_type": "presence",
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}
}
]
},
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},
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{
"not_criteria": {
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"requirement_type": "duration",
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"operator": ">=",
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"unit": "days"
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}
}
},
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}
}
]
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Currently taking testosterone or testosterone-like supplements, such as dehydroepiandrosterone (DHEA). Subject is eligible if he stops these agents for a total washout of 30 days prior to the Screening Visit and agrees not to use these agents for the duration of the study.",
"criterions": [
{
"exact_snippets": "Currently taking testosterone or testosterone-like supplements, such as dehydroepiandrosterone (DHEA).",
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"requirement_type": "presence",
"expected_value": false
}
},
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"exact_snippets": "Subject is eligible if he stops these agents for a total washout of 30 days prior to the Screening Visit",
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"requirement_type": "duration",
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"operator": ">=",
"value": 30,
"unit": "days"
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}
},
{
"exact_snippets": "agrees not to use these agents for the duration of the study.",
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"requirement_type": "agreement",
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}
}
]
},
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{
"exact_snippets": "Currently taking testosterone or testosterone-like supplements, such as dehydroepiandrosterone (DHEA).",
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"requirement_type": "presence",
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}
},
{
"exact_snippets": "Subject is eligible if he stops these agents for a total washout of 30 days prior to the Screening Visit",
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},
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},
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}
}
}
},
{
"identified_line": {
"line": "* Have a history of taking PC-SPES within the past two years.",
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{
"exact_snippets": "Have a history of taking PC-SPES within the past two years",
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}
}
]
},
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"requirement_type": "time frame",
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}
}
}
},
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"identified_line": {
"line": "* Currently taking herbal medicine or dietary supplements for prostate health, such as Saw Palmetto (also known as Serenoa Repens).",
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{
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}
},
{
"exact_snippets": "such as Saw Palmetto (also known as Serenoa Repens)",
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}
}
]
},
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}
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}
}
]
}
},
{
"identified_line": {
"line": "Subject is eligible if he stops these agents for a total washout of 30 days prior to taking the first dose of study drug and agrees not to use these agents for the duration of the study.",
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"operator": ">=",
"value": 30,
"unit": "days"
}
}
},
{
"exact_snippets": "agrees not to use these agents for the duration of the study",
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"expected_value": true
}
}
]
},
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"not_criteria": {
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"operator": ">=",
"value": 30,
"unit": "days"
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}
}
},
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}
}
}
]
}
},
{
"identified_line": {
"line": "Lycopene, vitamin E and selenium are not prohibited and no washout is required. However, vitamin E intake should be limited to less than 400 i.u. per day.",
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"exact_snippets": "Lycopene, vitamin E and selenium are not prohibited",
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"exact_snippets": "Lycopene, vitamin E and selenium are not prohibited",
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}
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}
},
{
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}
},
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"exact_snippets": "vitamin E intake should be limited to less than 400 i.u. per day",
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"operator": "<",
"value": 400,
"unit": "i.u. per day"
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}
}
]
},
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}
},
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"exact_snippets": "Lycopene, vitamin E and selenium are not prohibited",
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}
},
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}
},
{
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}
},
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}
}
}
]
}
},
{
"identified_line": {
"line": "* Have a history of thromboembolic event or disease including deep vein thrombosis, pulmonary embolus, or thrombotic stroke",
"criterions": [
{
"exact_snippets": "history of thromboembolic event or disease",
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}
},
{
"exact_snippets": "deep vein thrombosis",
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"expected_value": true
}
},
{
"exact_snippets": "pulmonary embolus",
"criterion": "pulmonary embolus",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "thrombotic stroke",
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"requirement": {
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"expected_value": true
}
}
]
},
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"and_criteria": [
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},
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}
},
{
"exact_snippets": "pulmonary embolus",
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}
},
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}
]
}
]
},
{
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}
},
{
"exact_snippets": "pulmonary embolus",
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"expected_value": true
}
},
{
"exact_snippets": "thrombotic stroke",
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}
}
]
}
},
{
"identified_line": {
"line": "* History of chronic hepatitis or cirrhosis",
"criterions": [
{
"exact_snippets": "History of chronic hepatitis",
"criterion": "chronic hepatitis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... cirrhosis",
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}
}
]
},
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"exact_snippets": "History of chronic hepatitis",
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"expected_value": true
}
},
{
"exact_snippets": "History of ... cirrhosis",
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"expected_value": true
}
}
]
}
}
],
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"failed_inclusion": [
{
"identified_line": {
"line": "* Agree to use an effective method of contraception, if the partner is of child-bearing age, while on study and for 30 days after the last dose of study medication",
"criterions": [
{
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"expected_value": true
}
},
{
"exact_snippets": "if the partner is of child-bearing age",
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}
},
{
"exact_snippets": "while on study and for 30 days after the last dose of study medication",
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]
},
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},
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"identified_line": {
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{
"exact_snippets": "adequate bone marrow ... function",
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}
},
{
"exact_snippets": "adequate ... liver ... function",
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}
},
{
"exact_snippets": "adequate ... renal function",
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}
]
},
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},
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{
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"value": 3000,
"unit": "mm3"
}
}
}
]
},
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}
}
},
{
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{
"exact_snippets": "Platelet Count ≥ 100,000/mm3",
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"value": 100000,
"unit": "mm3"
}
}
}
]
},
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}
}
},
{
"identified_line": {
"line": "* Bilirubin ≤ 1.5 mg/dL;",
"criterions": [
{
"exact_snippets": "Bilirubin ≤ 1.5 mg/dL",
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"value": 1.5,
"unit": "mg/dL"
}
}
}
]
},
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},
{
"identified_line": {
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{
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"value": 2,
"unit": "x upper limit of normal"
}
}
},
{
"exact_snippets": "AST and ALT < 2x upper limit of normal",
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"operator": "<",
"value": 2,
"unit": "x upper limit of normal"
}
}
}
]
},
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}
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "* Have evidence of prostate cancer (local, regional and/or distal metastasis)",
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{
"exact_snippets": "evidence of prostate cancer",
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}
},
{
"exact_snippets": "local, regional and/or distal metastasis",
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"distal"
]
}
}
]
},
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"exact_snippets": "evidence of prostate cancer",
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}
},
{
"or_criteria": [
{
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}
},
{
"exact_snippets": "local, regional and/or distal metastasis",
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}
},
{
"exact_snippets": "local, regional and/or distal metastasis",
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}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Have, in the judgment of the investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol",
"criterions": [
{
"exact_snippets": "clinically significant concurrent illness",
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}
},
{
"exact_snippets": "psychological, familial, sociological, geographical or other concomitant condition",
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"geographical",
"other"
]
}
},
{
"exact_snippets": "would not permit adequate follow-up and compliance with the study protocol",
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"requirement": {
"requirement_type": "capability",
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}
}
]
},
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}
}
}
],
"failed_miscellaneous": []
}