Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499174
Status:
TERMINATED
Last Update Posted:
2023-08-23
First Post:
2007-07-10
Brief Title:
Observation or Radical Treatment in Patients With Prostate Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed With Favourable Risk Prostate Cancer START
Status:
TERMINATED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not meeting accrual target
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Sometimes prostate tumours may not need treatment until they progress In this case observation may be sufficient Radical treatments such as radical prostatectomy or radiation therapy may be effective in treating prostate cancer when it is first diagnosed It is not yet known whether active surveillance is more effective than radical treatment as an initial intervention in favorable prognosis prostate cancer
PURPOSE This randomized phase III trial is studying active surveillance to see how well it works compared with radical treatment as an initial intervention in patients with favorable prognosis prostate cancer
PURPOSE This randomized phase III trial is studying active surveillance to see how well it works compared with radical treatment as an initial intervention in patients with favorable prognosis prostate cancer
Detailed Description:
OBJECTIVES
Primary
To compare disease-specific survival of patients with favorable risk prostate cancer treated with radical prostatectomy or radical radiotherapy at the time of initial diagnosis vs active surveillance and selective intervention based on pre-specified biochemical histological or clinical progression criteria
Secondary
To compare overall survival quality of life using the EPIC-26 RAND SF-12 and State-Trait Anxiety Inventory distant disease-free survival PSA relapseprogression after radical intervention and initiation of androgen deprivation therapy between the two treatment arms
To determine the proportion of patients on the active surveillance arm who receive radical intervention for prostate cancer
To determine if PSA doubling-time prior to diagnosis predicts eventual outcome
To determine if molecular biomarkers predict outcome
OUTLINE This is a prospective randomized multicenter study Patients are stratified by treatment center ECOG performance status 0 vs 1 or 2 disease stage T1 vs T2 baseline PSA value ngmL or μgL 50 vs 50 and 100 and age 65 years vs 65 years Patients are randomized to 1 of 2 arms
Arm I Patients undergo radical intervention radical prostatectomy or radiotherapy external-beam radiotherapy 5 days a week for 4-8 weeks permanent prostate brachytherapy or high-dose rate temporary brachytherapy based on patient and physician preference
Arm II Patients undergo active surveillance with radical intervention at the time one or more pre-specified criteria biochemical progression histologicgrade progression andor clinical progression are met
Quality of life is assessed by the EPIC-26 RAND SF-12 and State Anxiety Inventory at baseline periodically during study treatment and after completion of radical treatment
After completion of radical treatment patients are followed every 6 months
Primary
To compare disease-specific survival of patients with favorable risk prostate cancer treated with radical prostatectomy or radical radiotherapy at the time of initial diagnosis vs active surveillance and selective intervention based on pre-specified biochemical histological or clinical progression criteria
Secondary
To compare overall survival quality of life using the EPIC-26 RAND SF-12 and State-Trait Anxiety Inventory distant disease-free survival PSA relapseprogression after radical intervention and initiation of androgen deprivation therapy between the two treatment arms
To determine the proportion of patients on the active surveillance arm who receive radical intervention for prostate cancer
To determine if PSA doubling-time prior to diagnosis predicts eventual outcome
To determine if molecular biomarkers predict outcome
OUTLINE This is a prospective randomized multicenter study Patients are stratified by treatment center ECOG performance status 0 vs 1 or 2 disease stage T1 vs T2 baseline PSA value ngmL or μgL 50 vs 50 and 100 and age 65 years vs 65 years Patients are randomized to 1 of 2 arms
Arm I Patients undergo radical intervention radical prostatectomy or radiotherapy external-beam radiotherapy 5 days a week for 4-8 weeks permanent prostate brachytherapy or high-dose rate temporary brachytherapy based on patient and physician preference
Arm II Patients undergo active surveillance with radical intervention at the time one or more pre-specified criteria biochemical progression histologicgrade progression andor clinical progression are met
Quality of life is assessed by the EPIC-26 RAND SF-12 and State Anxiety Inventory at baseline periodically during study treatment and after completion of radical treatment
After completion of radical treatment patients are followed every 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| ICR-CTSU-ProSTART | OTHER | CTSU | httpsreporternihgovquickSearchU10CA077202 |
| U10CA077202 | NIH | None | None |
| CAN-NCIC-CTG-PR11 | REGISTRY | None | None |
| CALGB-140602 | OTHER | None | None |
| SWOG-PR11 | OTHER | None | None |
| CDR0000557348 | OTHER | None | None |
| RTOG-0873 | OTHER | None | None |
| ECOG-JPR11 | OTHER | None | None |