Search Clinical Trials
By Condition
By Location (USA)
By Location (Other)
By Sponsor
Resources
Privacy Policy
About Us
Disclaimer
To determine whether radical prostatectomy or expectant management is more effective in reducing mortality and extending life Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on To determine whether radical prostatectomy or expectant management is more effective in reducing mortality and extending life conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. To determine whether radical prostatectomy or expectant management is more effective in reducing mortality and extending life Clinical research trials and To determine whether radical prostatectomy or expectant management is more effective in reducing mortality and extending life health trials take place in a lot of 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 potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like To determine whether radical prostatectomy or expectant management is more effective in reducing mortality and extending life. To determine whether radical prostatectomy or expectant management is more effective in reducing mortality and extending life Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a To determine whether radical prostatectomy or expectant management is more effective in reducing mortality and extending life clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their To determine whether radical prostatectomy or expectant management is more effective in reducing mortality and extending life condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.

Home > "T" Clinical Trials Conditions > To determine whether radical prostatectomy or expectant management is more effective in reducing mortality and extending life

To determine whether radical prostatectomy or expectant management is more effective in reducing mortality and extending life



To determine whether radical prostatectomy or expectant management is more effective in reducing mortality and extending life

For Condition: Prostate Neoplasms
Status: No longer recruiting
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program,Agency for Health Care Research and Quality (AHRQ),National Cancer Institute (NCI)
Synopsis: Radical prostatectomy provides potentially curative removal of the cancer. However, it subjects patients to the morbidity and mortality of the surgery and may be neither necessary nor effective. Expectant management does not offer potential cure. However, it provides palliative therapy for symptomatic or metastatic disease progression, avoids potentially excessive and morbid interventions in asymptomatic patients, and emphasizes management approaches for focus on relieving symptoms while minimizing therapeutic complications. The primary objective of this study is to determine which of two strategies is superior for the management of clinically localized CAP: 1) radical prostatectomy with early aggressive intervention for disease persistence or recurrence, 2) expectant management with reservation of therapy for palliative treatment of symptomatic or metastatic disease progression. Outcomes include total mortality, CAP mortality, disease free and progression free survival, morbidity, quality of life, and cost effectiveness.
Details: Primary Hypothesis: To determine whether radical prostatectomy or expectant management is more effective in reducing mortality and extending life. Secondary Hypothesis: To determine which treatment strategy is superior in terms of prostate specific cancer mortality, quality of life, occurrence or recurrence of symptoms and need for cancer treatment. Intervention: 1) Radical prostatectomy, plus intervention for evidence of disease persistence or recurrence, 2) Expectant management with palliative therapy reserved for symptomatic or metastatic disease progression. Primary Outcomes: All cause mortality. Study Abstract: Cancer of the prostate (CAP) is the most common nondermatologic and the second most frequent cause of cancer deaths in men. No cure is currently possible for disseminated disease. Cancer confined to the prostate is believed to be curable, with the most frequently recommended therapy being surgical extirpation of the tumor with radical prostatectomy. However, despite increasing cancer detection and aggressive surgical treatment, population-based mortality rates from prostate cancer have not decreased, neither nationally nor in states with high rates of radical prostatectomy. Existing evidence does not demonstrate the superiority of this procedure compared to expectant management in the treatment of localized prostate cancer. Data from case series suggest that either treatment approach provides equivalent all-cause as well as prostate cancer specific mortality. The only randomized trial was limited by a small sample size but the results favored expectant management. Radical prostatectomy provides potentially curative removal of the cancer. However, it subjects patients to the morbidity and mortality of the surgery and may be neither necessary nor effective. Expectant management does not offer potential cure. However, it provides palliative therapy for symptomatic or metastatic disease progression, avoids potentially excessive and morbid interventions in asymptomatic patients, and emphasizes management approaches for focus on relieving symptoms while minimizing therapeutic complications. The primary objective of this study is to determine which of two strategies is superior for the management of clinically localized CAP: 1) radical prostatectomy with early aggressive intervention for disease persistence or recurrence, 2) expectant management with reservation of therapy for palliative treatment of symptomatic or metastatic disease progression. Outcomes include total mortality, CAP mortality, disease free and progression free survival, morbidity, quality of life, and cost effectiveness.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: /75 Years
Genders: Male
Protocol Entry Criteria: Patients with clinically localized CAP. Diagnosis of Prostate Cancer within previous 6 months. Age 75 years or younger.
Total Enrollment: 1050

Location and Contact Information:

Vamc - Sepulveda, Ca
Sepulveda,  California,  91343
United States
 

Vamc - Portland, Or
Portland,  Oregon,  97207-9823
United States
 

Vamc - San Francisco, Ca
San Francisco,  California,  94121
United States
 

Vamc - Boise, Id
Boise,  Idaho,  83702-4598
United States
 

Vamc - Lake City, Fl
Lake City,  Florida,  32025-5895
United States
 

Vamc - Bronx, Ny
Bronx,  New York,  10468
United States
 

Vamc - Madison, Wi
Madison,  Wisconsin,  53792
United States
 

Vamc - Memphis, Tn
Memphis,  Tennessee,  38104
United States
 

Vamc - Lexington, Ky
Lexington,  Kentucky,  40536
United States
 

Vamc - Indianapolis, in
Indianapolis,  Indiana,  46202-5250
United States
 

Vamc - Amarillo, Tx
Amarillo,  Texas,  79106
United States
 

Vamc - Los Angeles, Ca
Los Angeles,  California,  90073
United States
 

Vamc - Albany, Ny
Albany,  New York,  12208
United States
 

Vamc - Seattle, Wa
Seattle,  Washington,  98108-1597
United States
 

Vamc - Hampton, Va
Hampton,  Virginia,  23667
United States
 

Vamc - Oklahoma City, Ok
Oklahoma City,  Oklahoma,  73104
United States
 

Vamc - Iowa City, Ia
Iowa City,  Iowa,  52246
United States
 

Vamc - Brooklyn, Ny
Brooklyn,  New York,  11209
United States
 

Vamc - Little Rock, Ar
Little Rock,  Arkansas,  72205-5484
United States
 

Vamc - Temple, Tx
Temple,  Texas,  76504
United States
 

Vamc - Pittsburgh, Pa
Pittsburgh,  Pennsylvania,  15213
United States
 

Vamc - Ann Arbor, Mi
Ann Arbor,  Michigan,  48109-0330
United States
 

Vamc - Shreveport, La
Shreveport,  Louisiana,  71101
United States
 

Vamc - Birmingham, Al
Birmingham,  Alabama,  35294-3296
United States
 

Vamc - Tampa, Fl
Tampa,  Florida,  33612
United States
 

Vamc - Buffalo, Ny
Buffalo,  New York,  14215
United States
 

Vamc - Long Beach, Ca
Long Beach,  California,  90822
United States
 

Vamc - Dallas, Tx
Dallas,  Texas,  75216
United States
 

Vamc - Hines, Il
Maywood,  Illinois,  60153
United States
 

Vamc - Brockton, Ma
West Roxbury,  Massachusetts,  02132
United States
 

Vamc - East Orange, Nj
East Orange,  New Jersey,  07018-1095
United States
 

Vamc - Clarksburg, Wv
Clarksburg,  West Virginia,  26301
United States
 

Vamc - Providence, Ri
Providence,  Rhode Island,  02908
United States
 

Vamc - Palo Alto, Ca
Palo Alto,  California,  94304
United States
 

Vamc - Syracuse, Ny
Syracuse,  New York,  13210
United States
 

Vamc - Westside Chicago, Il
Chicago,  Illinois,  60612
United States
 


Additional Information:
Study ID Numbers:
  407; 
Study Start Date: June 1994
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007644

Other Prostate Neoplasms Studies:
1. To determine whether radical prostatectomy or expectant management is more effective in reducing mortality and extending life

Related Studies:

Other Prostate Neoplasms Clinical Trials
Other Tennessee Clinical Trials
Other Memphis Clinical Trials

To determine whether radical prostatectomy or expectant management is more effective in reducing mortality and extending life

Modify your Search

  Other Prostate Neoplasms Clinical Trials
  Other Tennessee Clinical Trials
  Other Memphis Clinical Trials


Warning: include(/var/www/cgi-bin/traxis/counter.php) [function.include]: failed to open stream: No such file or directory in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103

Warning: include() [function.include]: Failed opening '/var/www/cgi-bin/traxis/counter.php' for inclusion (include_path='.:/usr/local/lib/php') in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103