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Leuprorelin

Phase 3

Prostate Cancer | Small molecule | Oncology |Abbott Laboratories|Last Updated: Oct 12, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,071

FDA Designations

No designations recorded

Clinical trial landscape

Leuprorelin · 1 trial · 1 indication

Phase 3 1
NCT00193856RADAR Trial - Randomised Androgen Deprivation and RadiotherapyProstate Cancer
COMPLETED1,071 Analytics
PHASE3COMPLETED
RADAR Trial - Randomised Androgen Deprivation and Radiotherapy
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Prostate cancer-specific mortality.
Two main endpoint analyses are planned when 6.5 and 10 years have elapsed from randomisation of the last participant

Secondary Endpoints

Cumulative incidence of PSA progression
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
Two main endpoint analyses are planned when 6.5 and 10 years have elapsed from randomisation of the last participant
All-cause mortality
Two main endpoint analyses are planned when 6.5 and 10 years have elapsed from randomisation of the last participant
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AACTIVE_COMPARATORLH-RH analogue for 5 months prior to and during first month of radiation treatment (total 6 mths)
BACTIVE_COMPARATORLH-RH analogue for 5 months prior to and during first month of radiation treatment (total 6 months) + bisphosphonate therapy.
CEXPERIMENTALLH-RH analogue as for arm A, but continued for further 12 months (total 18 months)
DEXPERIMENTALLH-RH analogue as for arm A, but continued for further 12 months (total 18 months) + bisphosphonate therapy.

Interventions

NameTypeDescription
Leuprorelin AcetateDRUGLH-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 AcidDRUGZoledronic 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 therapyRADIATIONThe 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites24

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...

Countries:AustraliaNew Zealand
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Competitive Landscape -Prostate Cancer 254 trials

Frequently asked questions about Leuprorelin

What is Leuprorelin used for in Prostate Cancer?

Leuprorelin is used for the treatment of Prostate Cancer. It is an investigational small molecule being studied in the Phase 3 RADAR trial, which evaluates androgen deprivation combined with radiotherapy in patients with prostate cancer.

What does Leuprorelin target?

Leuprorelin targets the androgen receptor pathway, as it is used in androgen deprivation therapy for prostate cancer. The RADAR trial specifically combines leuprorelin with radiotherapy to assess its efficacy in this patient population.

Who makes Leuprorelin?

Leuprorelin is being developed by Abbott Laboratories, a company traded on the stock exchange under the ticker ABT. The drug is currently in Phase 3 clinical development for prostate cancer.

What phase is Leuprorelin in?

Leuprorelin is in Phase 3 clinical development. It is an investigational drug, not yet approved, and is being studied in the completed RADAR trial for prostate cancer.

What clinical trials is Leuprorelin in?

Leuprorelin is associated with one clinical trial, NCT00193856, titled 'RADAR Trial - Randomised Androgen Deprivation and Radiotherapy'. This Phase 3 trial enrolled 1,071 male participants aged 18 years and older in Australia and New Zealand, and it has been completed.

Is Leuprorelin the same as any other drug?

Leuprorelin is also known by other names, though specific alternative names are not provided in the available information. It is a small molecule used in androgen deprivation therapy for prostate cancer.