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Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer Clinical research trials and Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer. Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer clinical trial. Subjects frequently get the best healthcare possible for their Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer  Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer
Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer
For Condition: stage 1 prostate cancer,stage 2 prostate cancer,adenocarcinoma of the prostate
Status: Recruiting
Sponsor(s): University of Pittsburgh Cancer Institute , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase II trial to study the effectiveness of toremifene followed by radical prostatectomy in treating patients who have stage I or stage II prostate cancer.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JoelNelson, Study Chair, University of Pittsburgh Cancer Institute
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15232
United States
Recruiting Joel Nelson 412-605-3013
Additional Information:
Study ID Numbers: CDR0000068708; NCI-P01-0181,PCI-00-105,PCI-N01-CN-75018
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00020735
Other Stage 1 Prostate Cancer Studies:
1. Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
2. TG4010 in Treating Patients With Prostate Cancer
3. Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer
4. Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer
5. Docetaxel in Treating Patients Who Have Undergone Surgery for Prostate Cancer
Related Studies:
Other stage 1 prostate cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer
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