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

2014-08-27 03:13:46 | BioPortfolio

Summary

the purpose of this study "Leuprorelin associated with radiotherapy versus leuprorelin alone in T3 - T4 or pT3 (on biopsy) N0, M0 prostate cancer" is to assess the possible benefits of the combined treatment on the local or systemic recurrences and on quality of life.

Description

STUDY DESIGN :

French multicenter, open, randomized study on 2 parallel groups

First step : treatment during 3 years (excepted disease progression) with Leuprorelin 11,25 mg SR + radiotherapy 70 +/- 4 Grays(begun within 90 days after 1st leuprorelin injection) in the first arm and Leuprorelin 11,25 mg SR alone for the 2nd arm. A visit / 6 months.

Second step : follow-up without treatment during 2 years (excepted disease progression). A visit / 6 months.

Third step : Follow-up out of protocol. 1 data collection / year.

End of study when median follow-up = 5years.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Histologically Confirmed Locally Advanced Prostatic Cancer

Intervention

Leuprorelin 11,25 mg SR, Radiotherapy + hormonotherapy

Location

Clinique Mutualiste
Saint-etienne
France
42013

Status

Completed

Source

Laboratoires Takeda

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:46-0400

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