Adjuvant Leuprolide With or Without Docetaxel in High Risk Prostate Cancer After Radical Prostatectomy

Summary

This is a prospective, multicenter, open-label, randomized phase III study in participants at high risk of recurrent prostate cancer after radical prostatectomy. The study will investigate

* Treatment with docetaxel (TAXOTERE®) every three weeks (q3w) plus leuprolide acetate (ELIGARD®) versus leuprolide acetate alone (ELIGARD®)
* Immediate treatment following prostatectomy versus deferred treatment at the time of relapse

Using a 2x2 factorial design participants will therefore be randomized to

* Immediate adjuvant treatment with docetaxel plus leuprolide acetate (chemotherapy and hormonal therapy)
* Immediate adjuvant treatment with leuprolide acetate alone (hormonal therapy)
* Deferred treatment with docetaxel plus leuprolide acetate (chemotherapy and hormonal therapy)
* Deferred treatment with leuprolide acetate alone (hormonal therapy)

Primary Objective:

* The primary objective of the study is to compare progression-free survival using a 2x2 factorial design

Secondary Objectives:

* To compare the 5-year overall, cancer-specific and metastasis-free survival after systemic treatment between the groups
* To compare the safety and tolerability between Docetaxel in combination with leuprolide acetate and leuprolide acetate alone.
* To evaluate quality of life as measured by the FACT-P questionnaire.

Originally, 1696 participants were planned in the study (with 424 participants randomized to each arm). However, only a total of 211 participants completed the randomization procedure as of 26 September 2007. Thus, sanofi-aventis, in accordance with the Steering Committee, decided to stop the participant recruitment as of 26 September 2007. Participants who had already signed their Informed Consent (IC) before September 26, 2007 were allowed to enter the randomization if they met eligibility criteria. The final revised number of planned participants to be randomly assigned to the 4 treatment arms was 250, and 228 participants were actually randomized.

The final sample size did not allow all the statistical analyses to be conducted on efficacy data. Therefore, the protocol was amended to reflect the change in the plans for statistical analysis. The study was underpowered to serve as the basis for drawing conclusions regarding efficacy and quality of life (QoL) endpoints.

Conditions

• Prostatic Neoplasms

Interventions

DRUG

Docetaxel (TAXOTERE®) Chemotherapy

75 mg/m\^2 docetaxel administered intravenously over 1 hour on Day 1 every three weeks (q3w) for 6 cycles. The first cycle was to be administered within 8 days after randomization. Corticosteroid pre-medication was mandatory. The following schedule was recommended - 8 mg Dexamethasone orally for 6 doses given - the night before chemotherapy, the morning of chemotherapy, 1 hour before docetaxel infusion, the night of chemotherapy, the morning of the day after chemotherapy and the night of the day after chemotherapy.

DRUG

Leuprolide acetate ( ELIGARD®) Hormonal Therapy

22.5 mg leuprolide acetate injection administered subcutaneously (SC) every 3 months for 18 months. The first injection was to be administered within 8 days after randomization.

DRUG

Docetaxel (TAXOTERE®) Chemotherapy

75 mg/m\^2 docetaxel administered IV over 1 hour on Day 1 q3w for 6 cycles. The first cycle was to be administered within 30 days after progression was confirmed. Corticosteroid pre-medication was mandatory. The following schedule was recommended - 8 mg Dexamethasone orally for 6 doses given - the night before chemotherapy, the morning of chemotherapy, 1 hour before docetaxel infusion, the night of chemotherapy, the morning of the day after chemotherapy and the night of the day after chemotherapy.

DRUG

Leuprolide acetate ( ELIGARD®) Hormonal Therapy

22.5 mg leuprolide acetate injection administered subcutaneously (SC) every 3 months for 18 months. The first injection was to be administered within 30 days after progression is confirmed (on Day 1 of docetaxel administration).

DRUG

Leuprolide acetate ( ELIGARD®) Hormonal Therapy

22.5 mg leuprolide acetate injection administered subcutaneously (SC) every 3 months for 18 months. The first injection was to be administered within 30 days after progression is confirmed.

Sponsors & Collaborators

• Sanofi

  lead INDUSTRY

Principal Investigators

• Jean-Philippe Aussel · Sanofi

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-12-31

Primary Completion

2010-12-31

Completion

2010-12-31

Countries

• United States
• Australia
• Austria
• Brazil
• Canada
• France
• Germany
• India
• Israel
• Italy
• Mexico
• Netherlands
• Poland
• Russia
• South Africa
• Turkey (Türkiye)
• United Kingdom

Study Locations