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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00193856




Registration number
NCT00193856
Ethics application status
Date submitted
12/09/2005
Date registered
19/09/2005
Date last updated
12/10/2017

Titles & IDs
Public title
RADAR Trial - Randomised Androgen Deprivation and Radiotherapy
Scientific title
A Randomised Trial Investigating the Effect on Biochemical (PSA) Control and Survival of Different Durations of Adjuvant Androgen Deprivation in Association With Definitive Radiation Treatment for Localised Carcinoma of the Prostate.
Secondary ID [1] 0 0
ACTRN12607000097448
Secondary ID [2] 0 0
TROG 03.04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Leuprorelin Acetate
Treatment: Drugs - Zoledronic Acid
Treatment: Other - Conventional external beam therapy

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.


Treatment: Drugs: 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).

Treatment: Drugs: 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.

Treatment: Other: 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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Prostate cancer-specific mortality.
Timepoint [1] 0 0
Two main endpoint analyses are planned when 6.5 and 10 years have elapsed from randomisation of the last participant
Secondary outcome [1] 0 0
Cumulative incidence of PSA progression
Timepoint [1] 0 0
Two main endpoint analyses are planned when 6.5 and 10 years have elapsed from randomisation of the last participant
Secondary outcome [2] 0 0
Cumulative incidence of local, distant and bony progression and associated patterns of clinical progression
Timepoint [2] 0 0
Two main endpoint analyses are planned when 6.5 and 10 years have elapsed from randomisation of the last participant
Secondary outcome [3] 0 0
All-cause mortality
Timepoint [3] 0 0
Two main endpoint analyses are planned when 6.5 and 10 years have elapsed from randomisation of the last participant
Secondary outcome [4] 0 0
Changes in bone mineral density and osteopenic fracture
Timepoint [4] 0 0
One endpoint analysis is planned when 4.5 years have elapsed from randomisation of the last participant
Secondary outcome [5] 0 0
Quality of life assessment
Timepoint [5] 0 0
One endpoint analysis is planned when 3 years have elapsed from randomisation of the last participant
Secondary outcome [6] 0 0
Treatment related morbidity
Timepoint [6] 0 0
One endpoint analysis is planned when 4 years have elapsed from randomisation of the last participant
Secondary outcome [7] 0 0
Cumulative incidence of secondary therapeutic intervention
Timepoint [7] 0 0
Two main endpoint analyses are planned when 6.5 and 10 years have elapsed from randomization of the last participant

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2017
Sample size
Target
Accrual to date
Final
1071
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
Lismore Hospital - Lismore
Recruitment hospital [4] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [6] 0 0
Nepean Cancer Care Centre - Penrith
Recruitment hospital [7] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [8] 0 0
Riverina Cancer Care Centre - Wagga Wagga
Recruitment hospital [9] 0 0
Westmead Hospital - Wentworthville
Recruitment hospital [10] 0 0
Illawarra Cancer Care Centre - Wollongong
Recruitment hospital [11] 0 0
Royal Brisbane Hospital - Herston
Recruitment hospital [12] 0 0
Mater QRI - South Brisbane
Recruitment hospital [13] 0 0
John Flynn Private Hospital - Tugun
Recruitment hospital [14] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [15] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [16] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [17] 0 0
Andrew Love Cancer Care Centre, Geelong Hospital - Geelong
Recruitment hospital [18] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2480 - Lismore
Recruitment postcode(s) [4] 0 0
1871 - Liverpool
Recruitment postcode(s) [5] 0 0
2298 - Newcastle
Recruitment postcode(s) [6] 0 0
2751 - Penrith
Recruitment postcode(s) [7] 0 0
2069 - Sydney
Recruitment postcode(s) [8] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [9] 0 0
2145 - Wentworthville
Recruitment postcode(s) [10] 0 0
- Wollongong
Recruitment postcode(s) [11] 0 0
4029 - Herston
Recruitment postcode(s) [12] 0 0
4101 - South Brisbane
Recruitment postcode(s) [13] 0 0
4224 - Tugun
Recruitment postcode(s) [14] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [15] 0 0
7250 - Launceston
Recruitment postcode(s) [16] 0 0
8006 - East Melbourne
Recruitment postcode(s) [17] 0 0
3220 - Geelong
Recruitment postcode(s) [18] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Dunedin
Country [4] 0 0
New Zealand
State/province [4] 0 0
Hamilton
Country [5] 0 0
New Zealand
State/province [5] 0 0
Palmerston North
Country [6] 0 0
New Zealand
State/province [6] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Hunter Medical Research Institute (HMRI)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Health Research Council, New Zealand
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/industry
Name [4] 0 0
Novartis Pharmaceuticals
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Cancer Society of New Zealand
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University of Newcastle, Australia
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Calvary Mater Newcastle, Australia
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Maitland Cancer Appeal
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Commercial sector/industry
Name [9] 0 0
Abbott
Address [9] 0 0
Country [9] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT00193856
Trial related presentations / publications
Haworth 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.
Denham JW, Joseph D, Lamb DS, Spry NA, Duchesne G, Matthews J, Atkinson C, Tai KH, Christie D, Kenny L, Turner S, Gogna NK, Diamond T, Delahunt B, Oldmeadow C, Attia J, Steigler A. 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. Lancet Oncol. 2019 Feb;20(2):267-281. doi: 10.1016/S1470-2045(18)30757-5. Epub 2018 Dec 19.
Moulton 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.
Denham 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.
Denham JW, Joseph D, Lamb DS, Spry NA, Duchesne G, Matthews J, Atkinson C, Tai KH, Christie D, Kenny L, Turner S, Gogna NK, Diamond T, Delahunt B, Oldmeadow C, Attia J, Steigler A. 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. Lancet Oncol. 2014 Sep;15(10):1076-89. doi: 10.1016/S1470-2045(14)70328-6. Epub 2014 Aug 14.
Denham JW, Wilcox C, Joseph D, Spry NA, Lamb DS, Tai KH, Matthews J, Atkinson C, Turner S, Christie D, Gogna NK, Kenny L, Duchesne G, Delahunt B, McElduff P. 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. Lancet Oncol. 2012 Dec;13(12):1260-70. doi: 10.1016/S1470-2045(12)70423-0. Epub 2012 Nov 12. Erratum In: Lancet Oncol. 2014 Sep;15(10):e417. Dosage error in article text.
Denham JW, Wilcox C, Lamb DS, Spry NA, Duchesne G, Atkinson C, Matthews J, Turner S, Kenny L, Tai KH, Gogna NK, Ebert M, Delahunt B, McElduff P, Joseph D. Rectal and urinary dysfunction in the TROG 03.04 RADAR trial for locally advanced prostate cancer. Radiother Oncol. 2012 Nov;105(2):184-92. doi: 10.1016/j.radonc.2012.09.018. Epub 2012 Nov 3.
Public notes

Contacts
Principal investigator
Name 0 0
Jim Denham, FRANZCR
Address 0 0
University of Newcastle, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00193856