RADAR Trial - Randomised Androgen Deprivation and Radiotherapy
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ClinicalTrials.gov Identifier: NCT00193856 |
Recruitment Status :
Completed
First Posted : September 19, 2005
Last Update Posted : October 12, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Drug: Leuprorelin Acetate Drug: Zoledronic Acid Radiation: Conventional external beam therapy | Phase 3 |
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 |
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. |
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Quality of life assessment [ Time Frame: One endpoint analysis is planned when 3 years have elapsed from randomisation of the last participant ]
- Treatment related morbidity [ Time Frame: One endpoint analysis is planned when 4 years have elapsed from randomisation of the last participant ]
- 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 ]
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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
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
Study Chair: | Jim Denham, FRANZCR | University of Newcastle, Australia |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Prostate Cancer Androgen Deprivation Hormone Therapy RadiotherapyBisphosphonate Prostate Specific Antigen (PSA) |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital 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 |