Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007644
Status:
COMPLETED
Last Update Posted:
2020-02-24
First Post:
2000-12-29
Brief Title:
Prostate Cancer Intervention Versus Observation Trial PIVOT
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 407 - Prostate Cancer Intervention Versus Observation Trial PIVOT A Randomized Trial Comparing Radical Prostatectomy Versus Palliative Expectant Management for the Treatment of Clinically Localized Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIVOT
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None