RADAR Trial - Randomised Androgen Deprivation and Radiotherapy

What Was Tested

In this phase 3 trial, researchers set out to test Leuprolide.

It had four arms (groups): A (active comparator), B (active comparator), C (experimental) and D (experimental).

LH-RH analogue as for arm A, but continued for further 12 months (total 18 months).

The registry classes the interventions as drug and radiation.

More on the Plan

There are, however, enormous variations in prescribing practices which reflect uncertainty as to the appropriate indications.

An important issue is osteopenia.

Since work from Canada had indicated that continued AD for periods longer than three months produced additional shrinkage of the prostatic tumour, the TROG 96.01 trial incorporated a third arm: six months MAD prior to and during radiotherapy.

The trial completed its recruitment target of 800 eligible patients in early 2000.

Who Took Part

The registry lists 1071 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Histological confirmation of adenocarcinoma of the prostate in the three months prior to randomisation. Gleason primary and secondary pattern reported. If the volume of tumour in biopsies is too small for the pathologist to allocate a secondary pattern, the primary pattern alone is sufficient. PSA value obtained within one month of randomisation. No evidence of lymphatic or haematogenous metastases, as determined by negative chest x-ray, CT scan of abdomen and pelvis, and bone scan in the 3 months prior to randomisation. ECOG performance status 0 - 1.

The full record lists 9 inclusion and 12 exclusion criteria; among the exclusions: prior pelvic radiotherapy; inability to complete self administered qol questionnaire; prior bisphosphonate therapy.

How the Study Was Run

It was run as a randomized, factorial and open-label study.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2003-10 with completion listed for 2017-08.

It ran at 24 sites in Australia (18) and New Zealand (6).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 7 secondary outcomes, for example Cumulative incidence of PSA progression, Cumulative incidence of local, distant and bony progression and associated patterns of clinical progression, All-cause mortality, Changes in bone mineral density and osteopenic fracture, Quality of life assessment and Treatment related morbidity.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 1071 people.

With 1071 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.