Prostate Cancer
Conditions
Keywords
cancer of the prostate (CAP), cancer treatment, chronic diseases, expectant management, genitourinary, prostate, prostate specific cancer mortality, radical prostatectomy
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURERadical prostatectomy
Surgical removal of the prostate
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
National Cancer Institute (NCI)
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
No minimum to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with clinically localized CAP * Diagnosis of Prostate Cancer within previous 6 months * Age 75 years or younger
Exclusion criteria
PSA \> 50 ng/ml Bone scan consistent with metastatic disease Other evidence that cancer of the prostate is not clinically localized Diagnosis of prostate cancer greater than 12 months ago Life expectancy less than 10 years Serum creatinine greater than 3 mg/dl Myocardial infarction within last 6 months Unstable angina New York Heart Association Class III or IV congestive heart failure Severe pulmonary disease Lifer failure Severe dementia Debilitating illness Malignancies, except for nonmelanomatous skin cancer, in the last 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All Cause Mortality | From date of randomization until date of death from any cause, assessed until end of study, up to 16 years | Number of deaths from any cause. |
Countries
United States
Participant flow
Recruitment details
Enrollment begain in November 1994 and ended in January 2002 with follow-up through January 2010. We recruited men from 44 Department of Veterans Affairs sites and 8 National Cancer Institute sites.
Pre-assignment details
A total of 13,022 men were entered into study logs as potentially eligible. Based upon further chart review, 6707 met age, comorbidity and prostate cancer specific criteria and received detailed information about the study. From these, 5023 were considered likely to be eligible and a total of 731 men agreed to participate.
Participants by arm
| Arm | Count |
|---|---|
| Radical Prostatectomy Surgical removal of the prostate | 364 |
| Watchful Waiting Closely watching, waiting and treating symptoms if and when cancer progresses | 367 |
| Total | 731 |
Baseline characteristics
| Characteristic | Watchful Waiting | Radical Prostatectomy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 236 Participants | 242 Participants | 478 Participants |
| Age, Categorical Between 18 and 65 years | 131 Participants | 122 Participants | 253 Participants |
| Age, Continuous | 66.8 years STANDARD_DEVIATION 5.6 | 67.0 years STANDARD_DEVIATION 5.2 | 66.9 years STANDARD_DEVIATION 5.4 |
| Region of Enrollment United States | 367 participants | 364 participants | 731 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 367 Participants | 364 Participants | 731 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 364 | 0 / 367 |
| serious Total, serious adverse events | 171 / 364 | 183 / 367 |
Outcome results
Primary
All Cause Mortality
Number of deaths from any cause.
Time frame: From date of randomization until date of death from any cause, assessed until end of study, up to 16 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Radical Prostatectomy | All Cause Mortality | 171 Participants |
| Watchful Waiting | All Cause Mortality | 183 Participants |