A Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Participants With a Rising Prostate Specific Antigen (PSA)
NCT ID: NCT00514917
Last Updated: 2013-11-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
413 participants
INTERVENTIONAL
2007-07-31
2012-09-30
Brief Summary
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The secondary objectives were:
* To assess cancer specific survival;
* To compare overall survival between the 2 treatment groups;
* To evaluate patient-reported outcomes including quality of life, fatigue, and sexual functioning as measured by 3 different assessments.
Detailed Description
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Participants received study treatment for up to 18 months from the time of study therapy initiation or less if one of the following occurred: disease progression, unacceptable toxicity, death, participant refusal or treatment delay beyond the time frame that is permitted for each treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Docetaxel+Leuprolide+Bicalutamide
Participants received docetaxel 75 milligram per square meter (mg/m\^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
Docetaxel
75 mg/m\^2 intravenous infusion over 1 hour every 3 weeks up to 10 cycles.
Leuprolide
22.5 mg injection subcutaneously every 12 weeks up to 18 months.
Bicalutamide
50 mg tablet orally once daily for first 4 weeks of treatment.
Leuprolide+Bicalutamide
Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
Leuprolide
22.5 mg injection subcutaneously every 12 weeks up to 18 months.
Bicalutamide
50 mg tablet orally once daily for first 4 weeks of treatment.
Interventions
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Docetaxel
75 mg/m\^2 intravenous infusion over 1 hour every 3 weeks up to 10 cycles.
Leuprolide
22.5 mg injection subcutaneously every 12 weeks up to 18 months.
Bicalutamide
50 mg tablet orally once daily for first 4 weeks of treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of radical prostatectomy (pre-operative radiation therapy to the prostate or pelvis or salvage radiation after radical prostatectomy was allowed)
* Demonstration of biochemical progression of disease based on prostate specific antigen (PSA) doubling time. The minimum PSA value for eligibility was greater than or equal to (\>=) 1. PSA doubling time over three values must be equal to (=) 9 months with a minimum of 3 weeks between assessments
* Serum testosterone \>=100 nanogram per deciliter (ng/dL)
* Karnofsky performance status (KPS) \>=70 percent (%)
* Adequate organ function as defined by the following laboratory criteria:
* White blood cells \>=3500 per cubic millimeter (mm\^3)
* Absolute neutrophil count (ANC) \>=1500 per mm\^3
* Platelet count \>=100,000 per mm\^3
* Hemoglobin \>= 10.0 gram per deciliter (g/dL)
* Total Bilirubin less than or equal to (\<=) upper limit of normal (ULN) unless due to Gilbert's disease
* Creatinine l \<= 1.5 milligram per deciliter (mg/dL) or creatinine clearance \>=60 cubic centimeters per minute
* Aspartate transaminase (AST), alanine transaminase (ALT) and alkaline phosphatase within pre-defined ranges
* Previous hormonal therapy was allowed provided that the total duration of therapy did not exceed 6 months
* Man of childbearing potential who was willing to consent to use effective contraception while on treatment and for at least 3 months thereafter
* Participant who was willing and was able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Exclusion Criteria
* Uncontrolled serious active infection
* Anticipated duration of life \< 2 years
* Less than 5-year history of successful treatment for other cancers or concurrent active nonprostate cancer other than nonmelanoma dermatologic tumor
* Peripheral neuropathy \>=Grade 2
* History of hypersensitivity reaction to Docetaxel or other drugs formulated with polysorbate 80, leuprolide, or bicalutamide
* Prior chemotherapy within the past 10 years (except non-taxane based chemotherapy for treatment of other cancers); concurrent treatment on another clinical trial or with any other cancer therapy including chemotherapy, immunotherapy, radiotherapy (except salvage radiation therapy), chemoembolization therapy, cryotherapy
* Other severe acute or chronic medical conditions including psychiatric disease, or significant laboratory abnormality requiring further investigation that may cause undue risk for the participant's safety, delay or prohibit protocol participation, or interfere with the interpretation of study results, and in the judgment of the investigator would make the participant inappropriate for entry into this study
* Radiographic findings suspicious for metastatic disease in the treating physician's clinical judgment. Participant who had radiographically suspicious pelvic lymph nodes prior to radial prostatectomy, but who, at the time of enrollment did not have suspicious adenopathy was eligible. Participant was eligible even if he/she had tumor-containing pelvic adenopathy at the time of surgery as long as at the time of enrollment there was no radiographically evident nodal disease in the clinician's opinion
* Participant was the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
* Participant unlikely to comply with protocol or research tests, for example, uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
* Participant who participated in another clinical study/received investigational product within 30 days of screening
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
18 Years
MALE
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Barrett Childs, MD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Diegem, , Belgium
Sanofi-Aventis Administrative Office
Laval, , Canada
Sanofi-Aventis Administrative Office
Prague, , Czechia
Sanofi-Aventis Administrative Office
Frankfurt, , Germany
Sanofi-Aventis Administrative Office
Vilnius, , Lithuania
Sanofi-Aventis Administrative Office
Warsaw, , Poland
Sanofi-Aventis Administrative Office
Bratislava, , Slovakia
Sanofi-Aventis Administrative Office
Barcelona, , Spain
Countries
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Other Identifiers
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2007-000323-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
XRP6976J_3503
Identifier Type: -
Identifier Source: org_study_id