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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 October 2012 |
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Main ID: |
NCT00439751 |
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Date of registration:
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22/02/2007 |
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Primary sponsor: |
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Public title:
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Immediate Versus Deferred Androgen Deprivation Therapy,Goserelin for Recurrent Prostate Cancer After Radical Radiotherapy
ELAAT |
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Scientific title:
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A Randomized Comparison of Immediate Versus Deferred Androgen Deprivation Therapy Using Goserelin for Recurrent Prostate Cancer After Radical Radiotherapy. |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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1100 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00439751 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Contacts
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Name:
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Andrew Loblaw, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Odette Cancer Centre - Sunnybrook Health Sciences Centre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Males over 18 years of age with histological confirmation of adenocarcinoma of the
prostate.
2. Biochemical progression after radical radiotherapy with a total prostate dose > 52
Gy.
- In patients without previous radical prostatectomy, biochemical progression is
defined as PSA in the range of nadir + 2 ng/mL (Phoenix definition) to = 6 ng/mL
(this PSA must be within 30 days of randomization).
- In patients with previous radical prostatectomy, biochemical progression is
defined as a rising PSA (at least 2 values) in the range of 0.4 ng/mL to = 3
ng/mL (most recent PSA must be within 30 days of randomization).
Exclusion Criteria:
1. Patients who are within 4 years of their brachytherapy implantation date.
2. Patients with medical conditions in which goserelin or bicalutamide is
contraindicated in the opinion of the supervising oncologist or urologist.
3. Patients with another active malignancy or malignancy treatment within 5 years (basal
or squamous cell skin cancers are not excluded from this trial).
4. Patients with geographic inaccessibility precluding them from necessary follow-up.
5. Failure to provide written informed consent.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Drug: Goserelin Acetate
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Primary Outcome(s)
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Time to androgen independent disease (AID). AID is defined as the time from randomization to AID or last follow-up.
[Time Frame: Indefinitely]
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Secondary Outcome(s)
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Cause Specific Survival. The following will be considered as endpoints in assessing cause-specific survival: (1) Death adjudicated as due to prostate cancer (2) Death due to complications of ADT, irrespective of the status of malignancy.
[Time Frame: Indefinitely]
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Overall survival defined as the time from randomization to the time of death (from any cause) or to the last follow-up.
[Time Frame: Indefinitely]
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Quality of life will be measured at each 6 - month follow-up visit using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC), QLQ-C30 and QLQ-PR25.
[Time Frame: Indefinitely]
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Time to complications of advanced malignancy (CAM) and number of CAMs experienced are secondary outcome measures. The time to CAM will be defined as the interval from randomization to the first CAM.
[Time Frame: Indefinitely]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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