Immediate Versus Deferred Androgen Deprivation Therapy,Goserelin for Recurrent Prostate Cancer After Radical Radiotherapy

NCT00439751 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2016-07-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Goserelin Acetate

Continuous goserelin, 12 week (10.8 mg) depot, will be used as ADT for both study arms. It is supplied as a sterile syringe for subcutaneous use.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY
  • Ontario Clinical Oncology Group (OCOG)

    lead OTHER

Principal Investigators

  • Andrew Loblaw, MD · Odette Cancer Centre - Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2015-12-31
Completion
2016-06-30

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00439751 on ClinicalTrials.gov