Status:
COMPLETED
Immediate Versus Deferred Androgen Deprivation Therapy,Goserelin for Recurrent Prostate Cancer After Radical Radiotherapy
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
AstraZeneca
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
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 ...
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)...
Eligibility Criteria
Inclusion
- Males over 18 years of age with histological confirmation of adenocarcinoma of the prostate.
- 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
- Patients who are within 4 years of their brachytherapy implantation date.
- Patients with medical conditions in which goserelin or bicalutamide is contraindicated in the opinion of the supervising oncologist or urologist.
- Patients with another active malignancy or malignancy treatment within 5 years (basal or squamous cell skin cancers are not excluded from this trial).
- Patients with geographic inaccessibility precluding them from necessary follow-up.
- Failure to provide written informed consent.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00439751
Start Date
April 1 2007
End Date
June 1 2016
Last Update
July 12 2016
Active Locations (11)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
2
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
3
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
4
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 1C3