RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery

NCT00541047 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4236

Last updated 2023-11-13

No results posted yet for this study

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

More Related Trials

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 NCT00541047 on ClinicalTrials.gov