Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052481
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2003-01-24
Brief Title:
Quality of Life in Patients Undergoing Surgery or Brachytherapy for Stage II Prostate Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Health-Related Quality Of Life In Patients With Low Risk Localized Prostate Cancer Randomized To Radical Prostatectomy Or Brachytherapy
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 Quality of life assessment in patients undergoing prostate cancer treatment may help determine the intermediate-term and long-term effects of surgery and brachytherapy
PURPOSE Randomized clinical trial to study quality of life in patients undergoing radical prostatectomy or brachytherapy for stage II prostate cancer
PURPOSE Randomized clinical trial to study quality of life in patients undergoing radical prostatectomy or brachytherapy for stage II prostate cancer
Detailed Description:
OBJECTIVES
Compare changes in health-related quality of life HRQOL in patients with stage II prostate cancer up to 2 years after treatment with radical prostatectomy or brachytherapy
Compare the effect of baseline HRQOL age and other covariates on HRQOL improvement or deterioration in these patients up to 10 years after these treatments
Compare the effect of treatment modality on HRQOL improvement or deterioration in these patients up to 10 years after these treatments
Compare the effects of treatment failure on HRQOL in terms of disease progression in these patients
OUTLINE Patients are randomized to 1 of 2 arms on ACOSOG-Z0070 radical prostatectomy vs brachytherapy
Patients in both arms complete a quality of life questionnaire at baseline 2 and 6 months after treatment and then at 1 2 4 7 and 10 years after treatment
PROJECTED ACCRUAL A total of 500 patients 250 per group will be accrued for this study within 2 years
Compare changes in health-related quality of life HRQOL in patients with stage II prostate cancer up to 2 years after treatment with radical prostatectomy or brachytherapy
Compare the effect of baseline HRQOL age and other covariates on HRQOL improvement or deterioration in these patients up to 10 years after these treatments
Compare the effect of treatment modality on HRQOL improvement or deterioration in these patients up to 10 years after these treatments
Compare the effects of treatment failure on HRQOL in terms of disease progression in these patients
OUTLINE Patients are randomized to 1 of 2 arms on ACOSOG-Z0070 radical prostatectomy vs brachytherapy
Patients in both arms complete a quality of life questionnaire at baseline 2 and 6 months after treatment and then at 1 2 4 7 and 10 years after treatment
PROJECTED ACCRUAL A total of 500 patients 250 per group 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 |
|---|---|---|---|
| CDR0000258478 | REGISTRY | NCI Physician Data Query | None |
| ACOSOG-Z0071 | None | None | None |