Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT00439751
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
2007-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immediate Versus Deferred Androgen Deprivation Therapy,Goserelin for Recurrent Prostate Cancer After Radical Radiotherapy
Sponsor:
Ontario Clinical Oncology Group (OCOG)
Organization:
Study Overview
Official Title:
A Randomized Comparison of Immediate Versus Deferred Androgen Deprivation Therapy Using Goserelin for Recurrent Prostate Cancer After Radical Radiotherapy.
Status:
COMPLETED
Status Verified Date:
2015-06
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:
ELAAT
Brief Summary:
This is a prospective, multicentre, open-labelled, randomized controlled trial comparing the efficacy of immediate versus deferred androgen deprivation therapy (ADT) using goserelin (Zoladex®) in men with recurrent prostate cancer after radical radiotherapy.
1100 patients will be accrued from participating Canadian Urological Oncology Group sites in an estimated time of 3 years. First analysis is planned for 7 years after study recruitment is completed.
1100 patients will be accrued from participating Canadian Urological Oncology Group sites in an estimated time of 3 years. First analysis is planned for 7 years after study recruitment is completed.
Detailed Description:
Recurrent prostate cancer after radical radiation therapy is a common problem with often a long interval from biochemical failure to the time of symptomatic relapse. Androgen deprivation therapy (ADT) is the most commonly used intervention following radiation failure and currently is often started immediately after the recognition of biochemical failure in the absence of symptoms. ADT is associated with side effects that can impact on quality of life. It is unclear whether ADT reduces prostate-specific mortality. There is currently insufficient evidence on the timing of ADT with respect to prevention of prostate cancer death and quality of life and cost particularly for men with fast and slow prostate specific antigen (PSA) doubling times.
The general objective of the ELAAT trial is to determine the optimal timing of ADT in men with recurrent prostate cancer after radical radiotherapy.
Consenting patients who have undergone prior radical radiotherapy for prostate cancer and are now experiencing a recurrence will be screened for eligibility. If they are determined to be eligible, patients will be stratified according to PSA doubling time, pre-radiation Gleason Score, previous radical prostatectomy and clinical centre. After stratification, patients will be randomized to immediate versus deferred ADT based on the 1:1 ratio between the two arms.
Patients will be followed indefinitely and assessed formally at 6 month intervals after the date or randomization. Patients will be assessed for recurrent disease (biochemical failure), new primary cancer, complications of advanced malignancy, quality of life and overall survival.
The general objective of the ELAAT trial is to determine the optimal timing of ADT in men with recurrent prostate cancer after radical radiotherapy.
Consenting patients who have undergone prior radical radiotherapy for prostate cancer and are now experiencing a recurrence will be screened for eligibility. If they are determined to be eligible, patients will be stratified according to PSA doubling time, pre-radiation Gleason Score, previous radical prostatectomy and clinical centre. After stratification, patients will be randomized to immediate versus deferred ADT based on the 1:1 ratio between the two arms.
Patients will be followed indefinitely and assessed formally at 6 month intervals after the date or randomization. Patients will be assessed for recurrent disease (biochemical failure), new primary cancer, complications of advanced malignancy, quality of life and overall survival.
Study Oversight
Has Oversight DMC:
True
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?: