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


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.



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


Histologically Confirmed Locally Advanced Prostatic Cancer


Leuprorelin 11,25 mg SR, Radiotherapy + hormonotherapy


Clinique Mutualiste




Laboratoires Takeda

Results (where available)

View Results


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

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Medical and Biotech [MESH] Definitions

Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).

Radiotherapy given to augment some other form of treatment such as surgery or chemotherapy. Adjuvant radiotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

A premalignant change arising in the prostatic epithelium, regarded as the most important and most likely precursor of prostatic adenocarcinoma. The neoplasia takes the form of an intra-acinar or ductal proliferation of secretory cells with unequivocal nuclear anaplasia, which corresponds to nuclear grade 2 and 3 invasive prostate cancer.

The total amount of radiation absorbed by tissues as a result of radiotherapy.

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