Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002938
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
1999-11-01
Brief Title:
Surgery in Treating Patients With Prostate Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
The Role of Salvage Prostatectomy for Radiation Failure in Prostate Carcinoma A Phase II Trial
Status:
COMPLETED
Status Verified Date:
2016-07
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:
None
Brief Summary:
RATIONALE Prostatectomy may be an effective treatment for prostate cancer that has not responded to radiation therapy
PURPOSE This phase II trial is studying how well prostatectomy works in treating patients with recurrent or persistent prostate cancer that has not responded to radiation therapy
PURPOSE This phase II trial is studying how well prostatectomy works in treating patients with recurrent or persistent prostate cancer that has not responded to radiation therapy
Detailed Description:
OBJECTIVES
Determine the characteristics of failure-free survival disease-free survival overall survival surgical morbidity and mortality and quality of life of patients treated with salvage prostatectomy for the recurrence of persistent disease after treatment with prior radiotherapy for localized prostate cancer
Develop expertise in the use of salvage prostatectomy prior to a possible phase III trial of salvage prostatectomy in this population versus a control arm such as hormonal therapy or cryotherapy
Determine the quality of life measures in these patients
Determine the preliminary data on the quality of life of patients undergoing salvage radical prostatectomy and use the data to design a phase III study
Determine the histologic and morphometric characterization of the carcinoma
OUTLINE Patients undergo modified bilateral pelvic lymph node dissection
Patients with negative nodes undergo salvage prostatectomy via either retropubic or perineal approach Patients with positive nodes may undergo radical prostatectomy at the discretion of the investigator
Postoperative hormonal therapy may be given at time of symptomatic disease progression or a newly positive bone scan or for a consistently rising prostate-specific antigen Adjuvant hormonal therapy is also allowed
Quality of life is assessed prior to surgery and at 3 6 12 18 and 24 months after surgery
Patients are followed at least every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 2 years
Determine the characteristics of failure-free survival disease-free survival overall survival surgical morbidity and mortality and quality of life of patients treated with salvage prostatectomy for the recurrence of persistent disease after treatment with prior radiotherapy for localized prostate cancer
Develop expertise in the use of salvage prostatectomy prior to a possible phase III trial of salvage prostatectomy in this population versus a control arm such as hormonal therapy or cryotherapy
Determine the quality of life measures in these patients
Determine the preliminary data on the quality of life of patients undergoing salvage radical prostatectomy and use the data to design a phase III study
Determine the histologic and morphometric characterization of the carcinoma
OUTLINE Patients undergo modified bilateral pelvic lymph node dissection
Patients with negative nodes undergo salvage prostatectomy via either retropubic or perineal approach Patients with positive nodes may undergo radical prostatectomy at the discretion of the investigator
Postoperative hormonal therapy may be given at time of symptomatic disease progression or a newly positive bone scan or for a consistently rising prostate-specific antigen Adjuvant hormonal therapy is also allowed
Quality of life is assessed prior to surgery and at 3 6 12 18 and 24 months after surgery
Patients are followed at least every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 2 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000065381 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CALGB-9687 | None | None | None |