Prostatic NeoplasmsPhase 3NCT00283062
Adjuvant Leuprolide With or Without Docetaxel in High Risk Prostate Cancer After Radical Prostatectomy
A Phase 3 study testing Docetaxel (TAXOTERE®) Chemotherapy and Leuprolide acetate ( ELIGARD®) Hormonal Therapy in people with Prostatic Neoplasms, run by Sanofi at 17 sites in 17 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Docetaxel (TAXOTERE®) Chemotherapy and Leuprolide acetate ( ELIGARD®) Hormonal Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 17 sitesin 17 countries
- Study dates
- Dec 2005to Dec 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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)
Show all 18Show fewer
- 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.
Trial locations and contacts
17 sites in 17 countries.
17 sites in 17 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
United Kingdom1 site
Sanofi-Aventis Administrative Office
Guildford Surrey
About this study
Official 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
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
Read more
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.
Read the detailed description
The study consisted of the following:
- Randomization of eligible participants within 120 days of prostatectomy
- For participants assigned to immediate therapy, a treatment period up to 18 months within 8 days of randomization
- For participants assigned to deferred treatment, a treatment period up to 18 months after evidence of progression prior to December 2010. Participants who did not progress before December 2010 were withdrawn from the study.
- Conditions
- Prostatic Neoplasms
- Being tested
- Docetaxel (TAXOTERE®) Chemotherapy, Leuprolide acetate ( ELIGARD®) Hormonal Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel (TAXOTERE®) ChemotherapyDrug
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.
Leuprolide acetate ( ELIGARD®) Hormonal TherapyDrug
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.
Docetaxel (TAXOTERE®) ChemotherapyDrug
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.
Leuprolide acetate ( ELIGARD®) Hormonal TherapyDrug
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).
Leuprolide acetate ( ELIGARD®) Hormonal TherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) | Experimental | Participants administered docetaxel every three weeks (q3w) for 6 cycles in combination with leuprolide acetate every 3 months for 18 months immediately following prostatectomy. Receives: Drug: Docetaxel (TAXOTERE®) Chemotherapy; Drug: Leuprolide acetate ( ELIGARD®) Hormonal Therapy |
| Leuprolide Acetate - Immediate Treatment (I-HT) | Active comparator | Participants administered leuprolide acetate every 3 months for 18 months immediately following prostatectomy. Receives: Drug: Leuprolide acetate ( ELIGARD®) Hormonal Therapy |
| Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) | Experimental | 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 docetaxel every three weeks (q3w) for 6 cycles in combination with leuprolide acetate every 3 months for 18 months. Receives: Drug: Docetaxel (TAXOTERE®) Chemotherapy; Drug: Leuprolide acetate ( ELIGARD®) Hormonal Therapy |
| Leuprolide Acetate - Deferred Treatment (D-HT) | Active comparator | 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 with leuprolide acetate every 3 months for 18 months. Receives: Drug: Leuprolide acetate ( ELIGARD®) Hormonal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) Assessment - Number of Participants With Disease Progression
PFS is the interval from the date of surgery to date of progression. The date of progression was the earlier of
- first PSA increase to ≥ 0.4 ng/mL confirmed within two weeks
- date of the nadir, if PSA nadir did not reach < 0.4 ng/mL (for deferred arm)
- first radiological/ histological evidence of tumor progression
- death. Median PFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Median PFS could not be estimated. Reported is the number of participants with disease progression.
Measured: from the date of surgery up to 3 years after randomization of the last participant
Secondary outcomes (5)
Median Overall Survival (OS)
Overall survival (OS) was the time interval from the date of surgery to the date of death due to any cause.
Median OS was to be estimated using Kaplan-Meier Curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Moreover, median OS could not be estimated. Reported is the number of participants who died from any cause.
Measured: from the date of surgery up to 3 years after randomization of the last participant
Median Cancer-specific Survival (CSS)
The CSS was the time from the date of surgery to the date of death due to prostate cancer.
Median CSS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Therefore, based on a protocol amendment, median CSS was not estimated.
Measured: from the date of surgery up to 3 years after randomization of the last participant
Median Metastasis-free Survival (MFS)
MFS was the interval from the date of surgery to the date of the first clinical evidence of metastasis after treatment initiation. Metastasis was evaluated by a physical exam or radiologically on bone scan or CT scan. Local (palpable) progression, documented histologically or by imaging techniques was considered evidence of progression.
Median MFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Therefore, based on a protocol amendment, median MFS was not estimated.
Measured: from the date of surgery up to 3 years after randomization of the last participant
To Evaluate Quality of Life (QoL) as Measured Using a Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire
The FACT-P is a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better QoL with fewer symptoms. A score of 156 represents the best outcome.
Note: Enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn due to the low sample size.
Measured: from 30 days before randomization (baseline) and 18 months after treatment initiation (for change from baseline)
Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE)
Number of participants with treatment-emergent adverse events (TEAE). A TEAE was as any adverse event that occurred or worsened during the on-treatment period, which was the period from the day of first infusion of study treatment until 30 days after the last infusion of study treatment.
Measured: from treatment initiation up to 19 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Aussel, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283062
- Sponsor's protocol ID
- XRP6976J_3501
- Other IDs
- EudraCT # : 2004-002203-32
- Status last verified
- Dec 2010
- First submitted
- 26 Jan 2006
- Last updated
- 26 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00283062
- Acronym / sponsor ID
- XRP6976J_3501
- Conditions
- Prostatic Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Jan 2006 (estimated)
- Results
- Posted 23 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study consisted of the following:
- Randomization of eligible participants within 120 days of prostatectomy
- For participants assigned to immediate therapy, a treatment period up to 18 months within 8 days of randomization
- For participants assigned to deferred treatment, a treatment period up to 18 months after evidence of progression prior to December 2010. Participants who did not progress before December 2010 were withdrawn from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) | Experimental | Drug: Docetaxel (TAXOTERE®) Chemotherapy, Drug: Leuprolide acetate ( ELIGARD®) Hormonal TherapyParticipants administered docetaxel every three weeks (q3w) for 6 cycles in combination with leuprolide acetate every 3 months for 18 months immediately following prostatectomy. |
| Leuprolide Acetate - Immediate Treatment (I-HT) | Active comparator | Drug: Leuprolide acetate ( ELIGARD®) Hormonal TherapyParticipants administered leuprolide acetate every 3 months for 18 months immediately following prostatectomy. |
| Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) | Experimental | Drug: Docetaxel (TAXOTERE®) Chemotherapy, Drug: Leuprolide acetate ( ELIGARD®) Hormonal TherapyParticipants 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 docetaxel every three weeks (q3w) for 6 cycles in combination with leuprolide acetate every 3 months for 18 months. |
| Leuprolide Acetate - Deferred Treatment (D-HT) | Active comparator | Drug: Leuprolide acetate ( ELIGARD®) Hormonal TherapyParticipants 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 with leuprolide acetate every 3 months for 18 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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)
Key exclusion criteria (18 listed)
- 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 :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel (TAXOTERE®) Chemotherapy75 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 | Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) |
| Leuprolide acetate ( ELIGARD®) Hormonal Therapy22.5 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 / Leuprolide Acetate - Immediate Treatment (I-CHT), Leuprolide Acetate - Immediate Treatment (I-HT) |
| Docetaxel (TAXOTERE®) Chemotherapy75 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 | Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) |
| Leuprolide acetate ( ELIGARD®) Hormonal Therapy22.5 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 | Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) |
| Leuprolide acetate ( ELIGARD®) Hormonal Therapy22.5 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. | Drug | Leuprolide Acetate - Deferred Treatment (D-HT) |
Primary outcome
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
PFS is the interval from the date of surgery to date of progression. The date of progression was the earlier of * first PSA increase to ≥ 0.4 ng/mL confirmed within two weeks * date of the nadir, if PSA nadir did not reach < 0.4 ng/mL (for deferred arm) * first radiological/ histological evidence of tumor progression * death. Median PFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Median PFS could not be estimated. Reported is the number of participants with disease progression.
5 secondary outcomes
Median Overall Survival (OS)
Time frame: from the date of surgery up to 3 years after randomization of the last participant
Median Cancer-specific Survival (CSS)
Time frame: from the date of surgery up to 3 years after randomization of the last participant
Median Metastasis-free Survival (MFS)
Time frame: from the date of surgery up to 3 years after randomization of the last participant
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)
Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE)
Time frame: from treatment initiation up to 19 months after treatment initiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe Aussel study director
Sanofi
17 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel (TAXOTERE®) Chemotherapy and Leuprolide acetate ( ELIGARD®) Hormonal Therapy in people with Prostatic Neoplasms, run by Sanofi at 17 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Australia, Austria, Brazil, Canada and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2012.