Expired Study
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Pittsburgh, Pennsylvania 15232


Purpose:

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using toremifene may fight prostate cancer by reducing the production of androgens. PURPOSE: Randomized phase II trial to study the effectiveness of toremifene followed by radical prostatectomy in treating patients who have stage I or stage II prostate cancer.


Study summary:

OBJECTIVES: - Compare the percent of high-grade prostatic intraepithelial neoplasia (HGPIN) present in the radical prostatectomy tissue (excluding the luminal area) of patients with stage I or II adenocarcinoma of the prostate treated with toremifene vs observation alone followed by radical prostatectomy. - Compare the absolute and relative changes in HGPIN in patients treated with toremifene vs observation alone. - Compare biomarkers (including DNA ploidy and nuclear morphology; Ki67 and MIB-1 expression; bcl-2 expression; frequency of cells expressing apoptotic bodies; microvessel density; and intraprostatic testosterone, dihydrotestosterone (DHT), and estradiol) in the radical prostatectomy tissue of patients treated with toremifene vs observation alone. - Compare changes from baseline in serum biomarkers, particularly PSA and hormone profiles (testosterone, DHT, androstenedione, dehydroepiandrosterone, androstanediol-glucuronide, estradiol, and sex hormone binding globulin), in patients treated with toremifene vs observation alone. - Compare the safety of toremifene in these patients. - Determine the relationships among pairs of biomarkers, biomarker changes, and outcome measures, including toxicity of toremifene and posttreatment HGPIN in these patients. - Determine the relationship between HGPIN or biomarker responses and antiandrogen germline CAG repeat length polymorphism in patients treated with toremifene. - Compare the tumor volume, margin status, and pT stage in patients treated with toremifene vs observation alone. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center and baseline high-grade prostatic intraepithelial neoplasia (none vs more than 0% up to 10% vs more than 10%). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral toremifene daily for 3-6 weeks in the absence of unacceptable toxicity. - Arm II: Patients undergo observation alone. Patients in both arms then undergo radical prostatectomy. PROJECTED ACCRUAL: A total of 78 patients (52 for arm I, 26 for arm II) will be accrued for this study at a rate of 6-7 patients per month.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Organ-confined (cT1-2) disease (stage I or II) - Must be schedule to undergo radical prostatectomy - Prior sextant biopsy required PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Neutrophil count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - ALT and AST less than 2 times ULN - Alkaline phosphatase less than 2 times ULN - No chronic hepatitis or cirrhosis Renal: - Creatinine less than 1.5 times ULN Other: - No severe mental or physical illness that would preclude radical prostatectomy - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - At least 5 years since prior antiestrogen, antiandrogen, LHRH agonist, estrogen, or progestational agent Radiotherapy: - Not specified Surgery: - See Disease Characteristics


NCT ID:

NCT00020735


Primary Contact:

Study Chair
Joel B. Nelson, MD
University of Pittsburgh


Backup Contact:

N/A


Location Contact:

Pittsburgh, Pennsylvania 15232
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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