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Trial · Interventional

CompletedPhase 3Registry data

RADAR Trial - Randomised Androgen Deprivation and Radiotherapy

NCTNCT00193856 (opens ClinicalTrials.gov in a new tab)Other idTROG 03.04Other idACTRN12607000097448
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
1,071 participants (actual)
Sponsor
Trans Tasman Radiation Oncology Group · Other
Design
Randomized · Open label (no masking)
Countries
2 countries

Australia, New Zealand

Start
Oct 2003
Primary completion
Aug 2017
Completion
Aug 2017
First posted
19 Sept 2005 (estimated)
Last update posted
12 Oct 2017
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200520102015
  1. Ph 3

    RADAR Trial - Randomised Androgen Deprivation and Radiotherapy

    NCT00193856

    Oct 2003 to Aug 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Leuprorelin AcetateDrug
  • Zoledronic AcidDrug
  • Conventional external beam therapyRadiation

Arms4

  • Active comparator

    A

    LH-RH analogue for 5 months prior to and during first month of radiation treatment (total 6 mths)

  • Active comparator

    B

    LH-RH analogue for 5 months prior to and during first month of radiation treatment (total 6 months) + bisphosphonate therapy.

  • Experimental

    C

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

  • Experimental

    D

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Prostate cancer-specific mortality.

    Time frame · Two main endpoint analyses are planned when 6.5 and 10 years have elapsed from randomisation of the last participant

Secondary outcomes(7)

  1. Cumulative incidence of PSA progression

    Time frame · Two main endpoint analyses are planned when 6.5 and 10 years have elapsed from randomisation of the last participant

  2. Cumulative incidence of local, distant and bony progression and associated patterns of clinical progression

    Time frame · Two main endpoint analyses are planned when 6.5 and 10 years have elapsed from randomisation of the last participant

  3. All-cause mortality

    Time frame · Two main endpoint analyses are planned when 6.5 and 10 years have elapsed from randomisation of the last participant

  4. Changes in bone mineral density and osteopenic fracture

    Time frame · One endpoint analysis is planned when 4.5 years have elapsed from randomisation of the last participant

  5. Quality of life assessment

    Time frame · One endpoint analysis is planned when 3 years have elapsed from randomisation of the last participant

  6. Treatment related morbidity

    Time frame · One endpoint analysis is planned when 4 years have elapsed from randomisation of the last participant

  7. Cumulative incidence of secondary therapeutic intervention

    Time frame · Two main endpoint analyses are planned when 6.5 and 10 years have elapsed from randomization of the last participant

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2019

2 results

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): 10-year results from a randomised, phase 3, factorial trial.

Denham et al. 2019The Lancet. Oncologycited by 85

PMID 30579763DOI 10.1016/s1470-2045(18)30757-5PUB-30579763

Full text at the publisher2 results
Publisher pageSee results (2)

Indexing hint: Randomized controlled trial · 2014

10 results

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 et al. 2014The Lancet. Oncologycited by 88

PMID 25130995DOI 10.1016/s1470-2045(14)70328-6PUB-25130995

Full text at the publisher10 results
Publisher pageSee results (10)

Indexing hint: Randomized controlled trial · 2012

2 results

Rectal and urinary dysfunction in the TROG 03.04 RADAR trial for locally advanced prostate cancer.

Denham et al. 2012Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncologycited by 34

PMID 23127770DOI 10.1016/j.radonc.2012.09.018PUB-23127770

Full text at the publisher2 results
Publisher pageSee results (2)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2012

Corrected

Quality of life in men with locally advanced prostate cancer treated with leuprorelin and radiotherapy with or without zoledronic acid (TROG 03.04 RADAR): secondary endpoints from a randomised phase 3 factorial trial.

Denham et al. 2012The Lancet. Oncologycited by 43

PMID 23151431DOI 10.1016/s1470-2045(12)70423-0PUB-23151431

Full text at the publisher
Publisher pageRead the notice

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultHaworth A, Kearvell R, Greer PB, Hooton B, Denham JW, Lamb D, Duchesne G, Murray J, Joseph D. Assuring high quality treatment delivery in clinical trials - Results from the Trans-Tasman Radiation Oncology Group (TROG) study 03.04 "RADAR" set-up accuracy study. Radiother Oncol. 2009 Mar;90(3):299-306. doi: 10.1016/j.radonc.2008.10.011. Epub 2008 Nov 18. PMID 19017549
  • DerivedMoulton CR, House MJ, Lye V, Tang CI, Krawiec M, Joseph DJ, Denham JW, Ebert MA. Prostate external beam radiotherapy combined with high-dose-rate brachytherapy: dose-volume parameters from deformably-registered plans correlate with late gastrointestinal complications. Radiat Oncol. 2016 Oct 31;11(1):144. doi: 10.1186/s13014-016-0719-2. PMID 27799048
  • DerivedDenham JW, Steigler A, Joseph D, Lamb DS, Spry NA, Duchesne G, Atkinson C, Matthews J, Turner S, Kenny L, Tai KH, Gogna NK, Gill S, Tan H, Kearvell R, Murray J, Ebert M, Haworth A, Kennedy A, Delahunt B, Oldmeadow C, Holliday EG, Attia J. Radiation dose escalation or longer androgen suppression for locally advanced prostate cancer? Data from the TROG 03.04 RADAR trial. Radiother Oncol. 2015 Jun;115(3):301-7. doi: 10.1016/j.radonc.2015.05.016. Epub 2015 Jun 10. PMID 26072289

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. * Primary tumour stage T2b - 4 (UICC 2002), or T2a providing biopsies demonstrate Gleason score 7 or more, and presenting PSA 10 or more * 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 * No concurrent medical conditions likely to significantly reduce prospects of 5 year survival * Patient accessible to follow up at intervals specified in protocol * Written informed consent given (signed by both patient and investigator prior to randomisation) Exclusion Criteria: * Previous or concurrent malignancy within previous 5 years except for non-melanomatous skin cancer * Prostatectomy * Prior pelvic radiotherapy * Prior hormone treatment for prostate cancer * Inability to complete self administered QOL questionnaire * Prior bisphosphonate therapy * Serum creatinine \> 2 x ULN * Osteoporosis resulting in \>30% loss in vertebral height in one or more thoraco-lumbar vertebrae * Liver disease resulting in ALT or AST levels \>3 x ULN * Prolonged continuous glucocorticoid therapy \> 10 mg/day of prednisone equivalent (\>6 months) * Current treatment with bisphosphonate * Inability to attend for follow-up at the Investigator's clinic

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