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

This study has been completed.

Study NCT00283062 Information provided by Sanofi-Aventis

First Received on January 26, 2006. Last Updated on January 25, 2012 History of Changes

Results First Received: December 16, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Factorial Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Prostatic Neoplasms
Interventions:	Drug: Docetaxel (TAXOTERE®) Chemotherapy Drug: Leuprolide acetate ( ELIGARD®) Hormonal Therapy

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Originally, the study was planned for 1696 participants to be randomized. However, enrollment was not met and in September 2007, the Steering Committee decided to stop recruitment. Only participants who had signed Informed Consent by then and met eligibility criteria were randomized. 228 participants were randomized to this study.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)	Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
Leuprolide Acetate - Immediate Treatment (I-HT)	Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)	Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
Leuprolide Acetate - Deferred Treatment (D-HT)	Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.

Participant Flow: Overall Study

	Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)	Leuprolide Acetate - Immediate Treatment (I-HT)	Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)	Leuprolide Acetate - Deferred Treatment (D-HT)
STARTED	55	55	56	62
ADMINISTERED STUDY TREATMENT	50	51	20	17
COMPLETED HORMONAL THERAPY (6 Cycles)	44	48	15	13
COMPLETED CHEMOTHERAPY (6 Cycles)	43	0 ^[1]	15	0 ^[1]
COMPLETED	43	48	15	13
NOT COMPLETED	12	7	41	49
Did not receive any study medication	5	4	36	45
Adverse Event	2	0	1	0
Lost to Follow-up	1	0	1	0
Progressive disease	0	0	1	0
Participant did not wish to continue	3	2	1	0
Undefined	0	1	1	4
chemotherapy not completed (cycle 6)	1	0	0	0

[1]	Not applicable, since participants in this arm did not receive chemotherapy.

Baseline Characteristics

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Reporting Groups

	Description
Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)	Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
Leuprolide Acetate - Immediate Treatment (I-HT)	Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)	Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
Leuprolide Acetate - Deferred Treatment (D-HT)	Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.

Baseline Measures

	Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)	Leuprolide Acetate - Immediate Treatment (I-HT)	Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)	Leuprolide Acetate - Deferred Treatment (D-HT)	Total
Number of Participants [units: participants]	55	55	56	62	228
Age [units: years] Mean ± Standard Deviation	61.2 ± 7.4	61.6 ± 7.0	62.1 ± 7	62.9 ± 7.5	61.9 ± 7.2
Age, Customized [units: participants]
<65 years	37	34	35	35	141
>=65 years	18	21	21	27	87
Gender [units: participants]
Female	0	0	0	0	0
Male	55	55	56	62	228
Race/Ethnicity, Customized [units: participants]
White	48	49	43	59	199
Black	6	3	7	2	18
Asian/Oriental	0	1	4	0	5
Multiracial	0	0	2	0	2
Other	1	2	0	1	4

Outcome Measures

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1. Primary:

Progression-free Survival (PFS) Assessment - Number of Participants With Disease Progression [ Time Frame: from the date of surgery up to 3 years after randomization of the last participant ]

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2. Secondary:

Median Overall Survival (OS) [ Time Frame: from the date of surgery up to 3 years after randomization of the last participant ]

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3. Secondary:

Median Cancer-specific Survival (CSS) [ Time Frame: from the date of surgery up to 3 years after randomization of the last participant ]

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4. Secondary:

Median Metastasis-free Survival (MFS) [ Time Frame: from the date of surgery up to 3 years after randomization of the last participant ]

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5. Secondary:

To Evaluate Quality of Life (QoL) as Measured Using a Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire [ Time Frame: from 30 days before randomization (baseline) and 18 months after treatment initiation (for change from baseline) ]

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6. Secondary:

Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) [ Time Frame: from treatment initiation up to 19 months after treatment initiation ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The investigator shall provide the Steering Committee a copy of any manuscript, abstract or oral communication derived from the study for review and comment at least 30 days in advance of any submission. The Sponsor's representatives shall have the right to review and/or delay any publication or presentation to prevent disclosure of Sponsor's confidential information and preserve intellectual property rights.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study had difficulties in meeting enrollment goals within a reasonable time frame. The final sample size allowed for the safety analyses but was underpowered for drawing conclusions regarding efficacy and quality of life (QoL) endpoints.

Results Point of Contact:

Name/Title: Trial Transparency Team
Organization: Sanofi
e-mail: Contact-Us@sanofi.com

No publications provided

Responsible Party:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00283062 History of Changes
Obsolete Identifiers:	NCT00343967
Other Study ID Numbers:	XRP6976J_3501, EudraCT # : 2004-002203-32
Study First Received:	January 26, 2006
Results First Received:	December 16, 2011
Last Updated:	January 25, 2012
Health Authority:	France: Afssaps - French Health Products Safety Agency