A Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Participants With a Rising Prostate Specific Antigen (PSA)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00514917
• Date of registration: 02/08/2007
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: A Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Participants With a Rising Prostate Specific Antigen (PSA) Rising PSA
• Scientific title: A Randomized, Open Label, Multicenter, Phase III, 2-Arm Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Subjects With a Rising PSA Following Definitive Local Therapy
• Date of first enrolment: July 2007
• Target sample size: 413
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00514917
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Belgium, Canada, Croatia, Czech Republic, Finland, Germany, Lithuania, Poland, Slovakia, Spain, Ukraine, United States

Contacts

• Name: Barrett Childs, MD
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of prostate adenocarcinoma pathologically confirmed

- 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:

- Clinically significant cardiac disease (New York Heart Association Class III/IV), or
severe debilitating pulmonary disease

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostatic Neoplasms

Intervention(s)

Drug: Docetaxel

Drug: Leuprolide

Drug: Bicalutamide

Primary Outcome(s)

Progression-Free Survival (PFS) Rate at Month 36 in Testosterone Specific Evaluable Population [Time Frame: Month 36]

Median Progression-Free Survival (PFS) in Intent-to-treat (ITT) Population [Time Frame: Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60]

Median Progression-Free Survival (PFS) in Testosterone Specific Evaluable Population [Time Frame: Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60]

Progression-Free Survival (PFS) Rate at Month 36 in ITT Population [Time Frame: Month 36]

Secondary Outcome(s)

Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score at End of Treatment (EOT) [Time Frame: Baseline, EOT (up to Month 18)]

Overall Survival (OS): Number of Participants Who Died (All Cause) [Time Frame: Randomization until death due to any cause, assessed up to Month 60]

Cancer-Specific Survival: Number of Participants Who Died (Cancer-Specific) [Time Frame: Randomization until death due to prostate cancer, assessed up to Month 60]

Change From Baseline in Erectile Function Domain of International Index of Erectile Function (EF-IIEF) Total Score at EOT [Time Frame: Baseline, EOT (up to Month 18)]

Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Index Score at EOT [Time Frame: Baseline, EOT (up to Month 18)]

Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Trial Outcome Index (TOI) Score at EOT [Time Frame: Baseline, EOT (up to Month 18)]

Secondary ID(s)

2007-000323-17

XRP6976J_3503

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/11/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00514917