Estudio multicéntrico de eficacia y seguridad, aleatorizado, doble ciego, controlado con placebo, de citrato de toremifeno para la prevención del cáncer de próstata en varones con neoplasia intraepitelial prostática (NIP) de alto grado

CompletadoFase 3ClinicalTrials.gov

ID: NCT00106691Tipo: INTERVENTIONALInicio: 1 de ene de 2005Fin estimado: 1 de feb de 2010

Resumen

Descripción detallada

El propósito de este estudio es determinar si el citrato de toremifeno es eficaz y seguro en la prevención del cáncer de próstata en varones que han sido diagnosticados con neoplasia intraepitelial prostática de alto grado. Los varones que alguna vez hayan sido diagnosticados con NIP de alto grado serán incluidos en un ensayo de 36 meses y serán asignados a 20 mg del fármaco en estudio o placebo por día. Los sujetos se someterán a evaluaciones de seguridad en el Mes 3, Mes 6, Mes 12, Mes 18, Mes 24, Mes 30 y Mes 36, junto con biopsias de próstata en el Mes 12, Mes 24 y Mes 36 para determinar la eficacia.

Elegibilidad

Edad mínima: 30 YearsSexo: MALE

Criterios de inclusión

Give voluntary signed informed consent in accordance with institutional policies
Be male, aged ≥ 30 years
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
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
Have a serum PSA of ≤ 10 ng/mL
Agree to provide tablet containers for tablet counts and to complete a daily diary of study drug intake
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
Have adequate bone marrow, liver and renal function:
White Blood Cell (WBC) Count ≥ 3,000/mm3;
Platelet Count ≥ 100,000/mm3;
Bilirubin ≤ 1.5 mg/dL;
AST and ALT \< 2x upper limit of normal;
Serum Creatinine ≤ 2.0 mg%

Criterios de exclusión

Previous exposure to toremifene citrate
Have evidence of prostate cancer (local, regional and/or distal metastasis)
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).
Have active systemic viral, bacterial, or fungal infections requiring treatment
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
Concurrently being treated with other investigational agents or have participated in an investigational study within 60 days prior to screening
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.
Have previously taken finasteride for greater than two years
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.
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.
Have a history of taking PC-SPES within the past two years.
Currently taking herbal medicine or dietary supplements for prostate health, such as Saw Palmetto (also known as Serenoa Repens).
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.
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.
Have a history of thromboembolic event or disease including deep vein thrombosis, pulmonary embolus, or thrombotic stroke
History of chronic hepatitis or cirrhosis

Intervenciones

drug

Toremifene 20 mg

The subject takes one dose by mouth of the 20mg Toremifine Citrate tablet once a day for the length of the trial (360 days).

drug

Placebo

The subject takes a placebo tablet identical in appearance to the toremifene 20mg tablet, administered by mouth daily for 360 days.

Ubicaciones

Centro Urologico Buenos Aires

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Hospital Pirovano

Buenos Aires, Argentina

Policlinico Bancario de Buenos Aires

Buenos Aires, Argentina

Sanatorio Municipal

Buenos Aires, Argentina

Servicio de Urologia

Buenos Aires, Argentina

Patrocinadores

PrincipalGTx

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