RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery
NCT00541047 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4236
Last updated 2023-11-13
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy, such as goserelin, leuprolide, or bicalutamide, may lessen the amount of androgens made by the body. Giving radiation therapy together with androgen deprivation therapy may kill more prostate cancer cells.
PURPOSE: This randomized phase III trial is studying how well giving radiation therapy together with androgen deprivation therapy works in treating patients who have undergone surgery for prostate cancer.
Conditions
- Gastrointestinal Complications
- Prostate Cancer
- Sexual Dysfunction
- Urinary Complications
Interventions
- DRUG
-
bicalutamide
- DRUG
-
goserelin acetate
- DRUG
-
leuprolide acetate
- PROCEDURE
-
adjuvant therapy
- PROCEDURE
-
quality-of-life assessment
- RADIATION
-
radiation therapy
Sponsors & Collaborators
-
Canadian Cancer Trials Group
collaborator NETWORK -
University College, London
lead OTHER
Principal Investigators
-
Christopher Parker, MD · Royal Marsden NHS Foundation Trust
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 0 Years
- Max Age
- 120 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-11-30
- Primary Completion
- 2022-07-27
- Completion
- 2022-07-27
Countries
- Canada
- United Kingdom
Study Locations
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