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Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer Clinical research trials and Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer. Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer  Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer
Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer
For Condition: stage 3 prostate cancer,adenocarcinoma of the prostate
Status: Recruiting
Sponsor(s): EORTC Genito-Urinary Tract Cancer Cooperative Group ,
Synopsis: RATIONALE: Radical prostatectomy may be an effective treatment for locally advancedprostate cancer. PURPOSE: Phase II trial to study the effectiveness of radical prostatectomy in treating patients who have locally advanced prostate cancer.
Details: OBJECTIVES: - Determine the success rate of radical prostatectomy in patients with locally advanced adenocarcinoma of the prostate. - Determine the serious toxic event rate of this surgery in these patients. - Determine the pN status of patients treated with this surgery. - Determine the percentage of patients found to have organ-confined tumors (pT2) after undergoing this surgery. - Determine the 2-year prostate-specific antigen-free survival rate of patients treated with this surgery. - Determine the surgical morbidity rates of patients treated with this surgery. OUTLINE: This is a multicenter study. Patients undergo limited pelvic lymphadenectomy and then radical retropubic prostatectomy. Patients who are found to have pN-positive disease receive further treatment according to the investigator's discretion. Patients with pN0 disease are followed every 3 months for 1 year and then every 4 months for 1 year. PROJECTED ACCRUAL: A total of 32-74 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Unilateral cT3a, cN0, M0 - Well or moderately differentiated tumor - Gleason score no greater than 7 (4 plus 3 or 3 plus 4) - Total serum prostate-specific antigen no greater than 20 ng/mL (Hybritech equivalent) PATIENT CHARACTERISTICS: Age: - 70 and under Performance status: - WHO 0-1 Life expectancy: - Not specified Hematopoietic: - WBC greater than 3,000/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin greater than 9 g/dL Hepatic: - Bilirubin no greater than 1.5 times normal - ALT or AST less than 3 times normal - PT and PTT normal Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No preexisting uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy - No myocardial infarction within the past 6 months Pulmonary: - No gross abnormalities on chest x-ray Other: - No other disease that would preclude surgery - No other prior malignancy except adequately treated basal cell skin cancer - No other concurrent primary malignancy - No psychological, familial, sociological, or geographical condition that would preclude compliance PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - No prior hormonal therapy that would affect assessment of clinical T staging, margin positivity, or definitive pT staging Radiotherapy: - No prior pelvic radiotherapy that would affect surgical resectability and perioperative morbidity Surgery: - No prior surgery in the small pelvis (vascular surgery, mesh graft hernia repair, any surgery for benign prostatic hypertrophy, or transurethral resection of prostate) that would preclude prostatectomy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HeinPoppel, , U.Z. Gasthuisberg
Istituto Scientifico H.San Raffaele *Recruiting*
Milano, , 20132
Italy
Recruiting Contact Person 39-2-643-2653
Ospedale di Circolo e Fondazione Macchi *Recruiting*
Varese, , 21100
Italy
Recruiting Contact Person 39-278-111
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-16-332-211
Comenius University School of Medicine *Recruiting*
Martin, , 03659
Slovakia
Recruiting Contact Person 421-413-3034
Virga Jesse Hospital *Recruiting*
Hasselt, , 3500
Belgium
Recruiting Contact Person 32-11-309-990
Additional Information:
Study ID Numbers: CDR0000069068; EORTC-30001
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027794
Other Stage 3 Prostate Cancer Studies:
1. Perifosine in Treating Patients With Recurrent Prostate Cancer
2. DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer
3. Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases
4. Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer
5. Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer
Related Studies:
Other stage 3 prostate cancer Clinical Trials
Other Clinical Trials
Other Hasselt Clinical Trials
Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer
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