Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00193856 | RADAR Trial - Randomised Androgen Deprivation and Radiotherapy | PHASE3 | COMPLETED | 1,071 | — | — | Oct 1, 2003 | Aug 1, 2017 | Oct 12, 2017 | 24 | Australia, New Zealand |
| Arm | Type | Description |
|---|---|---|
| A | ACTIVE_COMPARATOR | LH-RH analogue for 5 months prior to and during first month of radiation treatment (total 6 mths) |
| B | ACTIVE_COMPARATOR | LH-RH analogue for 5 months prior to and during first month of radiation treatment (total 6 months) + bisphosphonate therapy. |
| C | EXPERIMENTAL | LH-RH analogue as for arm A, but continued for further 12 months (total 18 months) |
| D | EXPERIMENTAL | LH-RH analogue as for arm A, but continued for further 12 months (total 18 months) + bisphosphonate therapy. |
| Name | Type | Description |
|---|---|---|
| Leuprorelin Acetate | DRUG | 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). |
| Zoledronic Acid | DRUG | 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. |
| Conventional external beam therapy | RADIATION | 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. |
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 al...