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NCI HIGH PRIORITY CLINICAL TRIAL --- Prostatectomy Compared With Watchful Waiting in Treating Patients With Stage I or Stage II Prostate Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on NCI HIGH PRIORITY CLINICAL TRIAL --- Prostatectomy Compared With Watchful Waiting in Treating Patients With Stage I or Stage II Prostate Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. NCI HIGH PRIORITY CLINICAL TRIAL --- Prostatectomy Compared With Watchful Waiting in Treating Patients With Stage I or Stage II Prostate Cancer Clinical research trials and NCI HIGH PRIORITY CLINICAL TRIAL --- Prostatectomy Compared With Watchful Waiting in Treating Patients With Stage I or Stage II Prostate Cancer healthcare trials happen in a lot of of localities across 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 generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as NCI HIGH PRIORITY CLINICAL TRIAL --- Prostatectomy Compared With Watchful Waiting in Treating Patients With Stage I or Stage II Prostate Cancer. NCI HIGH PRIORITY CLINICAL TRIAL --- Prostatectomy Compared With Watchful Waiting in Treating Patients With Stage I or Stage II Prostate Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a NCI HIGH PRIORITY CLINICAL TRIAL --- Prostatectomy Compared With Watchful Waiting in Treating Patients With Stage I or Stage II Prostate Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their NCI HIGH PRIORITY CLINICAL TRIAL --- Prostatectomy Compared With Watchful Waiting in Treating Patients With Stage I or Stage II Prostate Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "N" Clinical Trials Conditions > NCI HIGH PRIORITY CLINICAL TRIAL --- Prostatectomy Compared With Watchful Waiting in Treating Patients With Stage I or Stage II Prostate Cancer  NCI HIGH PRIORITY CLINICAL TRIAL --- Prostatectomy Compared With Watchful Waiting in Treating Patients With Stage I or Stage II Prostate Cancer
NCI HIGH PRIORITY CLINICAL TRIAL --- Prostatectomy Compared With Watchful Waiting in Treating Patients With Stage I or Stage II Prostate Cancer
For Condition: adenocarcinoma of the prostate,stage 1 prostate cancer,stage 2 prostate cancer
Status: Recruiting
Sponsor(s): Department of Veterans Affairs Cooperative Studies Program , National Cancer Institute (NCI),Cancer and Leukemia Group B,Southwest Oncology Group,Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Watchful waiting until symptoms appear may be effective in patients with prostate cancer. It is not yet known if watchful waiting is more effective than prostatectomy for early prostate cancer. PURPOSE: Randomizedphase III trial to compare surgery with watchful waiting in men who have stage I or stage II prostate cancer.
Details: OBJECTIVES: - Compare the overall mortality rate in patients with clinically localized prostate cancer treated with radical prostatectomy and early intervention for subsequent disease progression vs expectant management with therapy reserved for palliation of symptomatic or metastatic disease. - Compare the prostate cancer-specific survival of patients treated with these regimens. - Compare the quality of life of patients treated with these regimens. - Compare the progression-free survival of patients treated with these regimens. - Determine the effects of radical prostatectomy on disease recurrence in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Within 6 weeks after randomization, patients undergo pelvic lymph node dissection (at the discretion of the urologist) followed within 2 weeks by radical prostatectomy. The choice of surgical procedure (retropubic, perineal, nerve sparing, or nonnerve sparing) is at the discretion of the urologist. Patients with metastases may undergo standard therapy, including prostatectomy, observation, orchiectomy or hormonal therapy, or radiotherapy. Patients with disease progression may undergo standard therapy, including hormonal therapy, radiotherapy, mechanical intervention, or observation. - Arm II: Patients undergo expectant management with interventions reserved for symptomatic or metastatic disease. Asymptomatic disease progression (e.g., enlarging mass on digital rectal exam or imaging study, increase in PSA) without evidence of metastatic disease is not considered an indication for intervention. Patients with symptomatic local progression are treated first with alpha blockers or mechanical intervention (e.g., transurethral resection of the prostate (TURP), transurethral incision of the prostate, stent placement). Patients with symptomatic regional progression undergo mechanical intervention, radiotherapy, or hormonal therapy, as indicated. Hormonal therapy is considered first-line therapy for patients with disease progression requiring nonmechanical therapy. Patients with disease that continues to progress or fails to respond to hormonal therapy undergo radiotherapy or chemotherapy. Patients with symptomatic local disease progression (defined as recurrent and persistent gross hematuria or bladder outlet obstruction) despite TURP, stents, and alpha blockers may undergo prostatectomy. Quality of life is assessed at baseline and then every 6 months. Patients are followed every 3 months for 1 year and then every 6 months for 15 years. PROJECTED ACCRUAL: A total of 1,050 patients will be accrued for this study within 7 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Adenocarcinoma of the prostate diagnosed within the past year - Clinically localized disease (T1a-c or T2a-c, NX, M0) - PSA no greater than 50 ng/mL - No evidence of metastatic disease on bone scan - No evidence of nonlocalized disease on other imaging studies PATIENT CHARACTERISTICS: Age: - 75 and under Performance status: - Not specified Life expectancy: - At least 10 years Hematopoietic: - Not specified Hepatic: - No severe hepatic impairment Renal: - Creatinine no greater than 3.0 mg/dL - No severe renal impairment Cardiovascular: - No New York Heart Association class III or IV heart disease - No myocardial infarction within the past 6 months - No unstable angina - No other severe cardiac impairment Pulmonary: - No severe pulmonary impairment Other: - No other significant concurrent medical condition that is acute or debilitating or would increase risk - No dementia - No nondermatologic malignancy within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for prostate cancer Endocrine therapy: - No prior hormonal therapy for prostate cancer - No concurrent estrogens or antiandrogens Radiotherapy: - No prior radiotherapy for prostate cancer Surgery: - No prior surgery for prostate cancer except transurethral resection Other: - No concurrent participation in another intervention research study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TimothyWilt, Study Chair, Veterans Affairs Medical Center - Minneapolis
Mercy Cancer Center at Mercy Medical Center-Des Moines *Recruiting*
Des Moines, Iowa, 50314
United States
Recruiting Roscoe Morton 515-247-3121
Westmead Hospital *Recruiting*
Westmead, New South Wales, 2145
Australia
Recruiting Richard Kefford 61-2-9845-6033
John Stoddard Cancer Center at Iowa Methodist Medical Center *Recruiting*
Des Moines, Iowa, 50309
United States
Recruiting Roscoe Morton 515-241-4245
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting Witold Rybka 717-531-1050
MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting Cynthia Cathcart 505-272-5688
Midlands Cancer Center at Midlands Community Hospital *Recruiting*
Papillion, Nebraska, 68128-4157
United States
Recruiting James Mailliard 402-593-3000
Iowa Lutheran Hospital *Recruiting*
Des Moines, Iowa, 50316-2301
United States
Recruiting Roscoe Morton 515-663-5612
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-3236
United States
Recruiting Timothy Moon 608-262-0475
Instituto de Enfermedades Neoplasicas *Recruiting*
Lima, , 34
Peru
Recruiting Carlos Vallejos-Sologuren 51-14-499-137
San Juan City Hospital *Recruiting*
San Juan, , 00936-7344
Puerto Rico
Recruiting Luis Baez-Diaz 787-641-3693
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54307-3453
United States
Recruiting Gerald Bayer 920-433-8889
Additional Information:
Study ID Numbers: CDR0000063882; VA-CSP-407,CALGB-9492,ECOG-VA407,SWOG-9450,PIVOT-1,NCI-T94-0131O
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002606
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. Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer
3. Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer
4. Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy
5. Hormone Therapy and OGX-011 Before Radical Prostatectomy in Treating Patients With Prostate Cancer
Related Studies:
Other stage 1 prostate cancer Clinical Trials
Other Clinical Trials
Other San Juan Clinical Trials
NCI HIGH PRIORITY CLINICAL TRIAL --- Prostatectomy Compared With Watchful Waiting in Treating Patients With Stage I or Stage II Prostate Cancer
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