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RADAR Trial - Randomised Androgen Deprivation and Radiotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00193856
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : October 12, 2017
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Hunter Medical Research Institute (HMRI)
Health Research Council, New Zealand
Novartis Pharmaceuticals
Cancer Society of New Zealand
University of Newcastle, Australia
Calvary Mater Newcastle, Australia
Maitland Cancer Appeal
Abbott
Information provided by (Responsible Party):
Trans Tasman Radiation Oncology Group

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Leuprorelin Acetate Drug: Zoledronic Acid Radiation: Conventional external beam therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1071 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Study Start Date : October 2003
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: A
LH-RH analogue for 5 months prior to and during first month of radiation treatment (total 6 mths)
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).

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.

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

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

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.

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193856


Locations
Show Show 24 study locations
Sponsors and Collaborators
Trans Tasman Radiation Oncology Group
National Health and Medical Research Council, Australia
Hunter Medical Research Institute (HMRI)
Health Research Council, New Zealand
Novartis Pharmaceuticals
Cancer Society of New Zealand
University of Newcastle, Australia
Calvary Mater Newcastle, Australia
Maitland Cancer Appeal
Abbott
Investigators
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Study Chair: Jim Denham, FRANZCR University of Newcastle, Australia
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Trans Tasman Radiation Oncology Group
ClinicalTrials.gov Identifier: NCT00193856    
Other Study ID Numbers: TROG 03.04
ACTRN12607000097448 ( Registry Identifier: Australian New Zealand Clinical Trials Registry )
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Keywords provided by Trans Tasman Radiation Oncology Group:
Prostate Cancer
Androgen Deprivation
Hormone Therapy
RadiotherapyBisphosphonate
Prostate Specific Antigen (PSA)
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Zoledronic Acid
Leuprolide
Bone Density Conservation Agents
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents