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RADAR Trial - Randomised Androgen Deprivation and Radiotherapy

NCT00193856 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1071

Last updated 2017-10-12

No results posted yet for this study

Summary

The principal objectives of the RADAR trial is to address the hypotheses; 1) that 18 months androgen deprivation in conjunction with radiotherapy is superior to 6 months androgen deprivation prior to and during radiotherapy; 2) that 18 months Bisphosphonate therapy will prevent bone loss caused by androgen deprivation therapy and further reduce relapse risk by impeding the development of bony metastases.

Conditions

Interventions

DRUG

Leuprorelin Acetate

LH-RH analogue (LH-RHa) (Leuprorelin acetate 22.5 mg) will be delivered as a depot injection every 3 months. This will be administered as an intramuscular injection (IMI).

DRUG

Zoledronic Acid

Zoledronic acid 4 mg will be delivered as an intravenous infusion over 15 minutes once every 3 months for 18 months, in patients randomised to bisphosphonate therapy.

RADIATION

Conventional external beam therapy

The prescribed dose will be 66 Gy in 33 fractions of 2 Gy to the ICRU 50 point utilising a minimum of three fields with \>= 6 MV photons.

Sponsors & Collaborators

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • Hunter Medical Research Institute (HMRI)

    collaborator UNKNOWN

  • Health Research Council, New Zealand

    collaborator OTHER

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • Cancer Society of New Zealand

    collaborator UNKNOWN

  • University of Newcastle, Australia

    collaborator OTHER

  • Calvary Mater Newcastle, Australia

    collaborator OTHER

  • Maitland Cancer Appeal

    collaborator UNKNOWN

  • Abbott

    collaborator INDUSTRY

  • Trans Tasman Radiation Oncology Group

    lead OTHER

Principal Investigators

  • Jim Denham, FRANZCR · University of Newcastle, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Australia
  • New Zealand

Study Locations

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Entities

Diseases
Companies

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 NCT00193856 on ClinicalTrials.gov