Leuprorelin Associated With Radiotherapy Versus Leuprorelin Alone in T3 - T4 or pT3 (on Biopsy) N0, M0 Prostate Cancer

Phase 3 Completed 273 enrolled Takeda

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the efficacy and safety of combined radiotherapy and hormone therapy and hormone therapy alone in the treatment of clinically locally advanced prostate cancer (T3-T4 or pT3 on biopsy, N0, M0).

Timeline

Start: 2000-03
Primary completion: 2008-12
Completion: 2009-06

Publications

Sargos P, Mottet N, Bellera C, Richaud P. Long-term androgen deprivation, with or without radiotherapy, in locally advanced prostate cancer: updated results from a phase III randomised trial. BJU Int. 2020 Jun;125(6):810-816. doi: 10.1111/bju.14768. Epub 2020 Mar 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Leuprorelin SR	Unknown	11.25 mg	Subcutaneous
Background	flutamide	Small molecule	250 mg	Oral

Leuprorelin Associated With Radiotherapy Versus Leuprorelin Alone in T3 - T4 or pT3 (on Biopsy) N0, M0 Prostate Cancer

Summary

Timeline

Publications

Drugs

Indications