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Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer Clinical research trials and Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer. Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer  Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer
Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer
For Condition: adenocarcinoma of the prostate,stage 2 prostate cancer
Status: Recruiting
Sponsor(s): American College of Surgeons , National Cancer Institute (NCI)
Synopsis: RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether surgery is more effective than internal radiation in treating prostate cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of surgery with that of internal radiation in treating patients who have stage II prostate cancer.
Details: OBJECTIVES: - Compare overall survival in patients with stage II prostate cancer treated with radical prostatectomy vs brachytherapy. - Compare metastasis-free survival and probability of survival without symptoms of patients treated with these regimens. - Compare the side effects of these treatment regimens in these patients. OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. - Arm I: Patients undergo radical prostatectomy. - Arm II: Patients undergo brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds Patients are followed every 6 months for 5 years and then annually thereafter. PROJECTED ACCRUAL: A total of 1,980 patients (990 per treatment arm) will be accrued for this study within 5.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate within the past 120 days - T1c-T2a, N0, M0 - No bilateral disease - Prostate-specific antigen (PSA) no greater than 10 ng/mL - In patients with prior neoadjuvant hormonal therapy (NHT), PSA must be less than 10 ng/mL prior to therapy - Gleason score no greater than 6 - Prostate gland less than 60 cc on transrectal ultrasound or with minimal pubic arch interference OR - Prostate gland 60 cc or greater prior to NHT allowed if prostate size has been reduced to less than 60 cc by NHT PATIENT CHARACTERISTICS: Age: - 75 and under Performance status: - ECOG 0-2 OR - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Creatinine no greater than 3 mg/dL Cardiovascular: - No significant cardiovascular disease - No New York Heart Association class III or IV heart disease Other: - No other malignancy within the past 5 years except effectively treated basal cell or squamous cell skin cancer or other malignancy at low risk for recurrence - No other condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - See Disease Characteristics - At least 90 days since prior NHT - Duration of therapy no greater than 120 days - No concurrent NHT Radiotherapy: - No prior radiotherapy to pelvis Surgery: - No prior surgery for prostate cancer or benign disease, including: - Transurethral resection of the prostate - Transurethral resection of the bladder neck - Cryotherapy - Laser ablation - Microwave therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulLange, Study Chair, University Cancer Center at University of Washington Medical Center
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1062
United States
Recruiting Kemp Kernstine 319-356-3407
Cancer Care Ontario-London Regional Cancer Centre *Recruiting*
London, Ontario, N6A 4L6
Canada
Recruiting David D'Souza 519-685-8650
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Julio Pow-Sang 813-972-8479
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Harry Clarke 843-792-1389
University Cancer Center at University of Washington Medical Center *Recruiting*
Seattle, Washington, 98195-6043
United States
Recruiting Paul Lange 206-543-3918
Utah Valley Regional Medical Center - Provo *Recruiting*
Provo, Utah, 84604
United States
Recruiting R. Noyes 801-408-3555
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Edward Messing 716-275-3345
Southern Illinois University School of Medicine *Recruiting*
Springfield, Illinois, 62794-9230
United States
Recruiting Thomas Tarter 217-545-7390
Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto, Ontario, M4N 3M5
Canada
Recruiting Laurence Klotz 416-480-4673
St. Vincent Cancer Center *Recruiting*
Little Rock, Arkansas, 72205-5499
United States
Recruiting J. Stallings 501-664-1762
Centre Hospitalier Universitaire de Quebec *Recruiting*
Quebec City, Quebec, G1R 2J6
Canada
Recruiting Yves Fradet 418-525-4444
Veterans Affairs Medical Center - Seattle *Recruiting*
Seattle, Washington, 98108
United States
Recruiting Paul Lange 206-543-3918
Washington University School of Medicine *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Gerald Andriole 314-362-8212
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Farhang Rabbani 646-422-4385
Sentara Norfolk General Hospital *Recruiting*
Norfolk, Virginia, 23507
United States
Recruiting Paul Schellhammer 757-457-5170
Kansas Cancer Institute at the University of Kansas Medical Center *Recruiting*
Kansas City, Kansas, 66160-7357
United States
Recruiting Carol Connor 913-588-6150
Northeast Heights Cancer Center *Recruiting*
Albuquerque, New Mexico, 87109
United States
Recruiting Paul Anthony 505-889-9639
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Martin Sanda 617-667-2960
Vancouver General Hospital *Recruiting*
Vancouver, British Columbia, V5Z 355
Canada
Recruiting Martin Gleave 604-875-5003
LDS Hospital *Recruiting*
Salt Lake City, Utah, 84143
United States
Recruiting R. Noyes 801-408-3555
Madigan Army Medical Center *Recruiting*
Tacoma, Washington, 98431-5048
United States
Recruiting Raymond Lance 253-968-2422
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94143-0128
United States
Recruiting Peter Carroll 415-353-7171
Walter Reed Army Medical Center *Recruiting*
Washington D.C., District of Columbia, 20307-5000
United States
Recruiting Judd Moul 240-453-8951
McKay-Dee Hospital Center *Recruiting*
Ogden, Utah, 84403
United States
Recruiting R. Noyes 801-408-3555
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting Edward Levine 336-716-4276
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting David McCready 416-946-6510
Wellspan Health - York Cancer Center *Recruiting*
York, Pennsylvania, 17403
United States
Recruiting Ronald Hempling 717-741-8100
Margaret and Charles Juravinski Cancer Centre *Recruiting*
Hamilton, Ontario, L8V 5C2
Canada
Recruiting Ian Davis 905-387-3445
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-6838
United States
Recruiting Joseph A. Smith 615-343-0234
Fletcher Allen Health Care - Medical Center Campus *Recruiting*
Burlington, Vermont, 05401
United States
Recruiting Mark Plante 802-847-2884
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Raphael Pollock 713-792-6928
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Eric Klein 216-444-5591
American Fork Hospital *Recruiting*
American Fork, Utah, 84003
United States
Recruiting R. Noyes 801-408-3555
Wilford Hall Medical Center *Recruiting*
Lackland Air Force Base, Texas, 78236-5300
United States
Recruiting Wade Sexton 210-292-5755
Veterans Affairs Medical Center - Richmond *Recruiting*
Richmond, Virginia, 23249
United States
Recruiting B. Grob 804-828-5318
Dixie Regional Medical Center *Recruiting*
St. George, Utah, 84770
United States
Recruiting R. Noyes 801-408-3555
Additional Information:
Study ID Numbers: CDR0000068851; ACOSOG-Z0070
Study Start Date:
Record last reviewed: August 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023686
Other Adenocarcinoma Of The Prostate Studies:
1. Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer
2. Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer
3. External-Beam Radiation Therapy Plus Implanted Radiation Therapy in Treating Patients With Prostate Cancer
4. Group Therapy Compared With Educational Materials in Patients With Prostate Cancer
5. Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer
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