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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00343967




Registration number
NCT00343967
Ethics application status
Date submitted
26/01/2006
Date registered
27/01/2006
Date last updated
26/01/2012

Titles & IDs
Public title
Adjuvant Leuprolide With or Without Docetaxel in High Risk Prostate Cancer After Radical Prostatectomy
Scientific title
A Multicenter, Open-Label, Randomized, Phase III Trial Comparing Immediate Adjuvant Hormonal Therapy (ELIGARD®- Leuprolide Acetate) in Combination With TAXOTERE® (Docetaxel) Administered Every Three Weeks Versus Hormonal Therapy Alone Versus Deferred Therapy Followed by the Same Therapeutic Options in Patients With Prostate Cancer at High Risk of Relapse After Radical Prostatectomy
Secondary ID [1] 0 0
EudraCT # : 2004-002203-32
Secondary ID [2] 0 0
XRP6976J_3501
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) - Participants administered docetaxel every three weeks (q3w) for 6 cycles in combination with leuprolide acetate every 3 months for 18 months immediately following prostatectomy.

Active comparator: Leuprolide Acetate - Immediate Treatment (I-HT) - Participants administered leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Participants who met all of the following criteria were considered for enrollment into the study.

* Pathologically confirmed adenocarcinoma of the prostate based on central pathology review. All other variants are excluded
* Randomization should occur less than 120 days after prostatectomy AND lymphadenectomy.
* A predicted probability of 5-year freedom from progression = 60%, as determined by the postoperative nomogram developed by M. Kattan.
* Bone-scan without evidence of metastasis (within 6 months of randomization)
* Chest x-ray without evidence of metastasis (within 6 months of randomization)
* Abdominal computed tomography (CT) Scan without evidence of metastasis (within 6 months of randomization)
* Eastern Cooperative Oncology Group (ECOG) performance status = 1
* Hematology evaluation within 2 weeks prior to randomization:

* Neutrophils = 2,000/mm3
* Hemoglobin = 10 g/dL
* Platelets = 100,000/mm3
* Hepatic and renal function evaluation within 2 weeks prior to randomization:

* Serum creatinine =1.5 × Upper normal limit (UNL) for the institution. If serum creatinine is > 1.5 × UNL, calculate creatinine clearance (should be = 60ml/minute).
* Total serum bilirubin = UNL for the institution. Participants with Gilbert's syndrome may be eligible if indirect serum bilirubin levels at the time of randomization and, at least 6 month prior to randomization, confirm this condition (i.e. elevated indirect serum bilirubin).
* Serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamic pyruvic transaminase (SGPT) = 1.5 × institutional UNL if alkaline phosphatase is = UNL OR
* alkaline phosphatase = 5 × UNL if SGOT and SGPT are = UNL
* Prostate Specific Antigen (PSA) evaluation within 9 months prior to prostatectomy. However, a 120-day timeframe is recommended
* Post operative PSA necessary for eligibility is defined as a level = 0.2ng/mL using a standard assay at least 30 days after radical prostatectomy and within 7 days prior to randomization. Note that randomization should occur within 120 days after radical prostatectomy
* Serum testosterone = 150ng/dL within 6 months prior to randomization.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Participants presenting with any of the following will not be included in the study.

* Prior systemic treatment for prostate cancer with hormonal therapy, chemotherapy, or any other anticancer therapy.
* Prior radiation therapy.
* Participants who received, are receiving or scheduled to receive post-operative radiotherapy.
* Participants taking alternative therapies for cancer must stop taking these therapies prior to randomization. Alternative therapies are not allowed during the treatment or follow-up portions of the study. This includes (but is not limited to) alternative therapies such as :

* PC-SPES (all types)
* 5-alpha reductase inhibitors
* Bisphosphonates are to be stopped prior to randomization and are not allowed during the study.
* Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose ( = 20 mg methylprednisolone per day or equivalent).
* History of a malignancy other than prostate cancer. Exceptions to these criteria include:

* participants with adequately treated non-melanoma skin cancers, and
* participants with a history of another malignancy that was curatively treated (including participants with superficial bladder cancer) and who have not had evidence of disease for a minimum of 5 years.
* Peripheral neuropathy = Grade 2.
* Electrocardiogram (ECG) with significant abnormalities (as determined by the investigator) within 90 days prior to randomization.
* Participants who are medically unstable, including but not limited to active infection, acute hepatitis, gastrointestinal bleeding, uncontrolled cardiac arrhythmias, interstitial lung disease, inflammatory bowel disease, uncontrolled angina, uncontrolled hypercalcemia, uncompensated congestive heart failure, uncontrolled diabetes, dementia, seizures, superior vena cava syndrome.
* Participants with history of hypersensitivity to polysorbate 80.
* Participants with a known history of viral hepatitis (B, C).

The above information was not intended to contain all considerations relevant to potential participation in a clinical trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
228
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT00343967
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Jean-Philippe Aussel
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00343967