Short-term androgen suppression and radiotherapy versus intermediate-term androgen suppression and radiotherapy, with or without zoledronic acid, in men with locally advanced prostate cancer (TROG 03.04 RADAR): an open-label, randomised, phase 3 factorial trial.

Denham JW, Joseph D, Lamb DS, Spry NA, Duchesne G, Matthews J, Atkinson C, Tai KH, Christie D, Kenny L, Turner S, Gogna NK and 5 more

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Diamond T, Delahunt B, Oldmeadow C, Attia J, Steigler A

The Lancet. Oncology14 Aug 2014Cited by 88 (Europe PMC)

PMID25130995DOI10.1016/s1470-2045(14)70328-6PepBankPUB-25130995

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Summary

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Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

01HumanRandomized controlled trialEfficacy outcome
In men with locally advanced prostate cancer, cancer mortality was 7·4% with ITAS versus 4·1% with STAS, without a significant difference.
In plain wordsIn men with prostate cancer, cancer mortality did not differ between longer and shorter leuprorelin treatment.
Peptide
Leuprolide
Outcome
No significant changeProstate cancer-specific mortality
Study
n = 536
Comparator
6 months of leuprorelin with radiotherapy (STAS)
Analysis
Primary
Outcome group
Mortality · Cancer
Studied dose
22·5 mg every 3 months · intramuscular · 18 monthsAs given in this study (human).
Measurements
Cumulative incidence of prostate cancer-specific mortality
7.4%
ITAS group (leuprorelin 18 months), 95% CI 4·6-11·0
Cumulative incidence of prostate cancer-specific mortality
4.1%
STAS group (leuprorelin 6 months), 95% CI 2·2-7·0
Source sentences
Summary
Cumulative incidences of prostate cancer-specific mortality were 4·1% (95% CI 2·2-7·0) in the STAS group, 7·8% (4·9-11·5) in the STAS plus zoledronic acid group, 7·4% (4·6-11·0) in the ITAS group, and 4·3% (2·3-7·3) in the ITAS plus zoledronic acid group.
4 context sentences(design, population, supporting numbers)
Summary · context
Neither prostate cancer-specific mortality nor all-cause mortality differed between control and experimental groups.
Summary · context
We did an open-label, randomised, 2 × 2 factorial trial in men with locally advanced prostate cancer (either T2a N0 M0 prostatic adenocarcinomas with prostate-specific antigen [PSA] ≥10 μg/L and a Gleason score of ≥7, or T2b-4 N0 M0 tumours regardless of PSA and Gleason score).
Summary · context
Patients in the control group were treated with neoadjuvant androgen suppression with leuprorelin (22·5 mg every 3 months, intramuscularly) for 6 months (short-term) and radiotherapy alone (designated STAS)
Summary · context
this procedure was either followed by another 12 months of androgen suppression with leuprorelin (intermediate-term; ITAS)
Report a problemFND-2513099501
02HumanRandomized controlled trialEfficacy outcome
In men with locally advanced prostate cancer, PSA progression was 29·2% with ITAS versus 34·2% with STAS, without a significant difference.
In plain wordsIn men with prostate cancer, PSA progression did not differ between longer and shorter leuprorelin treatment.
Peptide
Leuprolide
Outcome
No significant changePSA progression
Study
n = 536
Comparator
6 months of leuprorelin with radiotherapy (STAS)
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
22·5 mg every 3 months · intramuscular · 18 monthsAs given in this study (human).
Measurements
Cumulative incidence of PSA progression
29.2%
ITAS group (leuprorelin 18 months), 95% CI 23·8-34·8
Cumulative incidence of PSA progression
34.2%
STAS group (leuprorelin 6 months), 95% CI 28·6-39·9
Source sentences
Summary
Cumulative incidence of PSA progression was 34·2% (28·6-39·9) in the STAS group, 39·6% (33·6-45·5) in the STAS plus zoledronic acid group, 29·2% (23·8-34·8) in the ITAS group, and 26·0% (20·8-31·4) in the ITAS plus zoledronic acid group.
4 context sentences(design, population, supporting numbers)
Summary · context
Compared with STAS, no difference was noted in PSA progression with ITAS or STAS plus zoledronic acid;
Summary · context
We did an open-label, randomised, 2 × 2 factorial trial in men with locally advanced prostate cancer (either T2a N0 M0 prostatic adenocarcinomas with prostate-specific antigen [PSA] ≥10 μg/L and a Gleason score of ≥7, or T2b-4 N0 M0 tumours regardless of PSA and Gleason score).
Summary · context
Patients in the control group were treated with neoadjuvant androgen suppression with leuprorelin (22·5 mg every 3 months, intramuscularly) for 6 months (short-term) and radiotherapy alone (designated STAS)
Summary · context
this procedure was either followed by another 12 months of androgen suppression with leuprorelin (intermediate-term; ITAS)
Report a problemFND-2513099503
03HumanRandomized controlled trialEfficacy outcome
In men with locally advanced prostate cancer, local progression was 1·5% with ITAS versus 4·1% with STAS, without a significant difference.
In plain wordsIn men with prostate cancer, local progression did not differ between longer and shorter leuprorelin treatment.
Peptide
Leuprolide
Outcome
No significant changeLocal progression
Study
n = 536
Comparator
6 months of leuprorelin with radiotherapy (STAS)
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
22·5 mg every 3 months · intramuscular · 18 monthsAs given in this study (human).
Measurements
Cumulative incidence of local progression
1.5%
ITAS group (leuprorelin 18 months), 95% CI 0·5-3·7
Cumulative incidence of local progression
4.1%
STAS group (leuprorelin 6 months), 95% CI 2·2-7·0
Source sentences
Summary
Cumulative incidence of local progression was 4·1% (2·2-7·0) in the STAS group, 6·1% (3·7-9·5) in the STAS plus zoledronic acid group, 1·5% (0·5-3·7) in the ITAS group, and 3·4% (1·7-6·1) in the ITAS plus zoledronic acid group; no differences were noted between groups.
3 context sentences(design, population, supporting numbers)
Summary · context
We did an open-label, randomised, 2 × 2 factorial trial in men with locally advanced prostate cancer (either T2a N0 M0 prostatic adenocarcinomas with prostate-specific antigen [PSA] ≥10 μg/L and a Gleason score of ≥7, or T2b-4 N0 M0 tumours regardless of PSA and Gleason score).
Summary · context
Patients in the control group were treated with neoadjuvant androgen suppression with leuprorelin (22·5 mg every 3 months, intramuscularly) for 6 months (short-term) and radiotherapy alone (designated STAS)
Summary · context
this procedure was either followed by another 12 months of androgen suppression with leuprorelin (intermediate-term; ITAS)
Report a problemFND-2513099504
04HumanRandomized controlled trialEfficacy outcome
In men with locally advanced prostate cancer, bone progression was 8·4% with ITAS versus 7·5% with STAS, without a significant difference.
In plain wordsIn men with prostate cancer, bone progression did not differ between longer and shorter leuprorelin treatment.
Peptide
Leuprolide
Outcome
No significant changeBone progression
Study
n = 536
Comparator
6 months of leuprorelin with radiotherapy (STAS)
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
22·5 mg every 3 months · intramuscular · 18 monthsAs given in this study (human).
Measurements
Cumulative incidence of bone progression
8.4%
ITAS group (leuprorelin 18 months), 95% CI 5·5-12·2
Cumulative incidence of bone progression
7.5%
STAS group (leuprorelin 6 months), 95% CI 4·8-11·1
Source sentences
Summary
Cumulative incidences of bone progression were 7·5% (4·8-11·1), 14·6% (10·6-19·2), 8·4% (5·5-12·2), and 7·6% (4·8-11·2), respectively.
4 context sentences(design, population, supporting numbers)
Summary · context
Compared with STAS, STAS plus zoledronic acid increased the risk of bone progression (SHR 1·90, 95% CI 1·14-3·17; p=0·012), but no differences were noted with the other two groups.
Summary · context
We did an open-label, randomised, 2 × 2 factorial trial in men with locally advanced prostate cancer (either T2a N0 M0 prostatic adenocarcinomas with prostate-specific antigen [PSA] ≥10 μg/L and a Gleason score of ≥7, or T2b-4 N0 M0 tumours regardless of PSA and Gleason score).
Summary · context
Patients in the control group were treated with neoadjuvant androgen suppression with leuprorelin (22·5 mg every 3 months, intramuscularly) for 6 months (short-term) and radiotherapy alone (designated STAS)
Summary · context
this procedure was either followed by another 12 months of androgen suppression with leuprorelin (intermediate-term; ITAS)
Report a problemFND-2513099505
05HumanRandomized controlled trialEfficacy outcome
In men with locally advanced prostate cancer, distant progression was 14·2% with ITAS versus 14·7% with STAS, without a significant difference.
In plain wordsIn men with prostate cancer, distant progression did not differ between longer and shorter leuprorelin treatment.
Peptide
Leuprolide
Outcome
No significant changeDistant progression
Study
n = 536
Comparator
6 months of leuprorelin with radiotherapy (STAS)
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
22·5 mg every 3 months · intramuscular · 18 monthsAs given in this study (human).
Measurements
Cumulative incidence of distant progression
14.2%
ITAS group (leuprorelin 18 months), 95% CI 10·3-18·7
Cumulative incidence of distant progression
14.7%
STAS group (leuprorelin 6 months), 95% CI 10·7-19·2
Source sentences
Summary
Cumulative incidence of distant progression was 14·7% (10·7-19·2) in the STAS group, 17·3% (13·0-22·1) in the STAS plus zoledronic acid group, 14·2% (10·3-18·7) in the ITAS group, and 11·1% (7·6-15·2) in the ITAS plus zoledronic acid group; no differences were recorded between groups.
3 context sentences(design, population, supporting numbers)
Summary · context
We did an open-label, randomised, 2 × 2 factorial trial in men with locally advanced prostate cancer (either T2a N0 M0 prostatic adenocarcinomas with prostate-specific antigen [PSA] ≥10 μg/L and a Gleason score of ≥7, or T2b-4 N0 M0 tumours regardless of PSA and Gleason score).
Summary · context
Patients in the control group were treated with neoadjuvant androgen suppression with leuprorelin (22·5 mg every 3 months, intramuscularly) for 6 months (short-term) and radiotherapy alone (designated STAS)
Summary · context
this procedure was either followed by another 12 months of androgen suppression with leuprorelin (intermediate-term; ITAS)
Report a problemFND-2513099506
06HumanRandomized controlled trialEfficacy outcome
In men with locally advanced prostate cancer, secondary intervention occurred in 20·7% with ITAS versus 25·6% with STAS, without a significant difference.
In plain wordsIn men with prostate cancer, additional treatment did not differ between longer and shorter leuprorelin treatment.
Peptide
Leuprolide
Outcome
No significant changeSecondary therapeutic intervention
Study
n = 536
Comparator
6 months of leuprorelin with radiotherapy (STAS)
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
22·5 mg every 3 months · intramuscular · 18 monthsAs given in this study (human).
Measurements
Cumulative incidence of secondary therapeutic intervention
20.7%
ITAS group (leuprorelin 18 months), 95% CI 16·1-25·9
Cumulative incidence of secondary therapeutic intervention
25.6%
STAS group (leuprorelin 6 months), 95% CI 20·5-30·9
Source sentences
Summary
Cumulative incidence of secondary therapeutic intervention was 25·6% (20·5-30·9), 28·9% (23·5-34·5), 20·7% (16·1-25·9), and 15·3% (11·3-20·0), respectively.
4 context sentences(design, population, supporting numbers)
Summary · context
Compared with STAS, ITAS plus zoledronic acid reduced the need for secondary therapeutic intervention (SHR 0·67, 95% CI 0·48-0·95; p=0·024); no differences were noted with the other two groups.
Summary · context
We did an open-label, randomised, 2 × 2 factorial trial in men with locally advanced prostate cancer (either T2a N0 M0 prostatic adenocarcinomas with prostate-specific antigen [PSA] ≥10 μg/L and a Gleason score of ≥7, or T2b-4 N0 M0 tumours regardless of PSA and Gleason score).
Summary · context
Patients in the control group were treated with neoadjuvant androgen suppression with leuprorelin (22·5 mg every 3 months, intramuscularly) for 6 months (short-term) and radiotherapy alone (designated STAS)
Summary · context
this procedure was either followed by another 12 months of androgen suppression with leuprorelin (intermediate-term; ITAS)
Report a problemFND-2513099507
07HumanRandomized controlled trialSafety outcome
In men with locally advanced prostate cancer, all-cause mortality was 19·4% with ITAS versus 17·0% with STAS, without a significant difference.
In plain wordsIn men with prostate cancer, overall mortality did not differ between longer and shorter leuprorelin treatment.
Peptide
Leuprolide
Outcome
No significant changeAll-cause mortality
Study
n = 536
Comparator
6 months of leuprorelin with radiotherapy (STAS)
Outcome group
Mortality · Cancer
Studied dose
22·5 mg every 3 months · intramuscular · 18 monthsAs given in this study (human).
Measurements
Cumulative incidence of all-cause mortality
19.4%
ITAS group (leuprorelin 18 months), 95% CI 15·0-24·7
Cumulative incidence of all-cause mortality
17%
STAS group (leuprorelin 6 months), 95% CI 13·0-22·1
Source sentences
Summary
Cumulative incidence of all-cause mortality was 17·0% (13·0-22·1), 18·9% (14·6-24·2), 19·4% (15·0-24·7), and 13·9% (10·3-18·8), respectively.
4 context sentences(design, population, supporting numbers)
Summary · context
Neither prostate cancer-specific mortality nor all-cause mortality differed between control and experimental groups.
Summary · context
We did an open-label, randomised, 2 × 2 factorial trial in men with locally advanced prostate cancer (either T2a N0 M0 prostatic adenocarcinomas with prostate-specific antigen [PSA] ≥10 μg/L and a Gleason score of ≥7, or T2b-4 N0 M0 tumours regardless of PSA and Gleason score).
Summary · context
Patients in the control group were treated with neoadjuvant androgen suppression with leuprorelin (22·5 mg every 3 months, intramuscularly) for 6 months (short-term) and radiotherapy alone (designated STAS)
Summary · context
this procedure was either followed by another 12 months of androgen suppression with leuprorelin (intermediate-term; ITAS)
Report a problemFND-2513099502
08HumanRandomized controlled trialSafety outcome
In men with locally advanced prostate cancer, 18 months of androgen suppression did not adversely affect long-term morbidity.
In plain wordsIn men with prostate cancer, longer leuprorelin treatment did not worsen long-term illness compared with shorter treatment.
Peptide
Leuprolide
Outcome
Direction not reportedLong-term morbidity
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
22·5 mg every 3 months · intramuscular · 18 monthsAs given in this study (human).
Source sentences
Summary
Long-term morbidity and quality-of-life scores were not affected adversely by 18 months of androgen suppression or zoledronic acid.
3 context sentences(design, population, supporting numbers)
Summary · context
We did an open-label, randomised, 2 × 2 factorial trial in men with locally advanced prostate cancer (either T2a N0 M0 prostatic adenocarcinomas with prostate-specific antigen [PSA] ≥10 μg/L and a Gleason score of ≥7, or T2b-4 N0 M0 tumours regardless of PSA and Gleason score).
Summary · context
Patients in the control group were treated with neoadjuvant androgen suppression with leuprorelin (22·5 mg every 3 months, intramuscularly) for 6 months (short-term) and radiotherapy alone (designated STAS)
Summary · context
this procedure was either followed by another 12 months of androgen suppression with leuprorelin (intermediate-term; ITAS)
Report a problemFND-2513099509
09HumanRandomized controlled trialEfficacy outcome
In men with locally advanced prostate cancer, 18 months of androgen suppression did not adversely affect quality-of-life scores.
In plain wordsIn men with prostate cancer, longer leuprorelin treatment did not worsen quality of life compared with shorter treatment.
Peptide
Leuprolide
Outcome
Direction not reportedQuality of life
Study
n: not reported in source
Outcome group
Quality of life · Whole body
Studied dose
22·5 mg every 3 months · intramuscular · 18 monthsAs given in this study (human).
Source sentences
Summary
Long-term morbidity and quality-of-life scores were not affected adversely by 18 months of androgen suppression or zoledronic acid.
3 context sentences(design, population, supporting numbers)
Summary · context
We did an open-label, randomised, 2 × 2 factorial trial in men with locally advanced prostate cancer (either T2a N0 M0 prostatic adenocarcinomas with prostate-specific antigen [PSA] ≥10 μg/L and a Gleason score of ≥7, or T2b-4 N0 M0 tumours regardless of PSA and Gleason score).
Summary · context
Patients in the control group were treated with neoadjuvant androgen suppression with leuprorelin (22·5 mg every 3 months, intramuscularly) for 6 months (short-term) and radiotherapy alone (designated STAS)
Summary · context
this procedure was either followed by another 12 months of androgen suppression with leuprorelin (intermediate-term; ITAS)
Report a problemFND-2513099510
10HumanObservational studyEfficacy outcome
In men with prostate tumors of Gleason score 7 or lower, post-hoc analyses suggested better outcomes with ITAS than STAS.
In plain wordsIn men with lower Gleason scores, exploratory analyses suggested better outcomes with longer than shorter leuprorelin treatment.
Peptide
Leuprolide
Outcome
Not applicablePost-hoc outcomes in Gleason score 7 or lower tumors
Study
n: not reported in source
Comparator
6 months of leuprorelin with radiotherapy (STAS)
Analysis
Exploratory
Outcome group
Tumor growth · Cancer
Studied dose
22·5 mg every 3 months · intramuscular · 18 monthsAs given in this study (human).
Source sentences
Summary
Post-hoc analyses suggested that the reductions in PSA progression and decreased need for secondary therapeutic intervention with ITAS plus zoledronic acid were restricted to tumours with a Gleason score of 8-10, and that ITAS was better than STAS in tumours with a Gleason score of 7 or lower.
3 context sentences(design, population, supporting numbers)
Summary · context
We did an open-label, randomised, 2 × 2 factorial trial in men with locally advanced prostate cancer (either T2a N0 M0 prostatic adenocarcinomas with prostate-specific antigen [PSA] ≥10 μg/L and a Gleason score of ≥7, or T2b-4 N0 M0 tumours regardless of PSA and Gleason score).
Summary · context
Patients in the control group were treated with neoadjuvant androgen suppression with leuprorelin (22·5 mg every 3 months, intramuscularly) for 6 months (short-term) and radiotherapy alone (designated STAS)
Summary · context
this procedure was either followed by another 12 months of androgen suppression with leuprorelin (intermediate-term; ITAS)
Report a problemFND-2513099508

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT00193856

RADAR Trial - Randomised Androgen Deprivation and Radiotherapy

Trans Tasman Radiation Oncology Groupn = 1,071Oct 2003 to Aug 2017

Prostate Cancer

Trial page ClinicalTrials.govUpdated 12 Oct 2017

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

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