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Androgen Ablation With or Without Docetaxel in Treating Patients With Advanced Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00796458
Recruitment Status : Unknown
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : November 24, 2008
Last Update Posted : August 12, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE November 21, 2008
First Posted Date  ICMJE November 24, 2008
Last Update Posted Date August 12, 2013
Study Start Date  ICMJE April 2005
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2008)
2-year progression-free survival rate
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2008)
  • Overall survival
  • Time to treatment failure
  • Toxicity as assessed by NCI CTCAE criteria
  • PSA response rate (> 50% reduction from baseline)
  • Disease response rate as assessed by RECIST criteria (in patients with measurable disease)
  • PSA normalization (normal range 0-4 ng/mL)
  • Quality of life
  • Efficacy of treatment in controlling bone pain
  • Changes in chromogranin A levels
  • Cost analysis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Androgen Ablation With or Without Docetaxel in Treating Patients With Advanced Prostate Cancer
Official Title  ICMJE Phase III Study of Chemo-hormonal Therapy Versus Hormonal Therapy Alone in Advanced Hormone-naives Prostate Cancer Patients.
Brief Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving androgen ablation therapy together with docetaxel is more effective than giving androgen ablation therapy alone in treating patients with advanced prostate cancer.

PURPOSE: This randomized phase III trial is studying androgen ablation and docetaxel to see how well they work compared with androgen ablation alone in treating patients with advanced prostate cancer.

Detailed Description

OBJECTIVES:

Primary

  • Compare the 2-year progression-free survival rate (biological progression and/or clinical progression) in patients with advanced prostate cancer treated with androgen ablation with vs without docetaxel.

Secondary

  • Compare the overall survival of patients treated with these regimens.
  • Compare the time to treatment failure in patients treated with these regimens.
  • Compare the toxicity profiles of these regimens in these patients.
  • Compare the PSA response rate in patients treated with these regimens.
  • Compare the response rate in patients with measurable disease treated with these regimens.
  • Compare the percentage of patients who undergo PSA normalization.
  • Compare the quality of life of patients treated with these regimens.
  • Compare the efficacy of these regimens in controlling bone pain in these patients.
  • Compare the changes in chromogranin A levels in patients treated with these regimens.
  • Compare the total cost of care of patients treated with these regimens.

OUTLINE: This is a multicenter study.

Patients receive luteinizing hormone-releasing hormone analogue (LHRH-A) therapy for 6 months. Patients also receive antiandrogen therapy during the first 5 weeks of LHRH-A therapy. After 6 months of LHRH-A therapy, patients with PSA response are randomized to 1 of 2 treatment arms.

  • Arm I: Patients continue to receive LHRH-A therapy until disease progression.
  • Arm II:Patients receive LHRH-A therapy as in arm I. Patients also receive docetaxel IV on day 1. Treatment with docetaxel repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients complete questionnaires during treatment to assess bone pain. Quality of life is also assessed.

After completion to study therapy, patients are followed for ≥ 2 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Prostate Cancer
Intervention  ICMJE
  • Drug: docetaxel
    Given IV
  • Drug: releasing hormone agonist therapy
    Patients receive luteinizing hormone-releasing hormone analogue therapy until disease progression.
Study Arms  ICMJE
  • Active Comparator: Arm I
    Patients continue to receive LHRH-A therapy until disease progression.
    Intervention: Drug: releasing hormone agonist therapy
  • Experimental: Arm II
    Patients receive LHRH-A therapy as in arm I. Patients also receive docetaxel IV on day 1. Treatment with docetaxel repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: docetaxel
    • Drug: releasing hormone agonist therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 21, 2008)
200
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • Meets one of the following criteria

    • Metastatic disease
    • Systemic progressive disease after locoregional therapy (surgery or radiotherapy)
    • No metastatic disease AND meets one of the following criteria:

      • Circulating PSA levels ≥ 50 ng/mL (confirmed by ≥ 2 subsequent evaluations)
      • Biochemical progression with a PSA doubling time < 6 months (with ≥ 3 measurements taken 1 month apart) after primary locoregional treatment (radical prostatectomy or radiotherapy) with curative intent
      • Prostate-confined tumor with high-risk features whose therapy of choice is androgen deprivation
  • No symptomatic brain metastases or leptomeningeal disease

PATIENT CHARACTERISTICS:

  • ECOG or Zubrod performance status 0-2
  • Life expectancy ≥ 6 months
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Bilirubin ≤ 2.0 mg/dL
  • AST/ALT ≤ 1.5 times upper limit of normal
  • Creatinine ≤ 1.5 mg/dL
  • No active infection requiring IV antibiotics
  • No active ulcer, unstable diabetes mellitus, or other contraindication to corticotherapy
  • None of the following cardiovascular conditions:

    • Uncompensated heart failure (ejection fraction < 40%)
    • Myocardial infarction or revascularization procedure within the past 6 months
    • Unstable angina pectoris
    • Uncontrolled cardiac arrhythmia
  • No other severe clinical condition that, in the judgment of the local investigator, would place the patient at undue risk or interfere with the study
  • Not a prisoner
  • No prior malignancy, except for non-melanoma skin cancer, in situ cervical carcinoma, or other cancer that was curatively treated with no evidence of disease for ≥ 5 years
  • No familial, social, or geographical condition or significant neurologic or psychiatric disorder that would preclude understanding or rendering informed consent or fully complying with study treatment and follow-up

PRIOR CONCURRENT THERAPY:

  • At least 5 years since prior radiotherapy outside the prostate
  • Prior hormonal therapy allowed provided it was administered for ≤ 6 months
  • At least 12 months since prior hormonal therapy
  • More than 30 days since prior participation in another clinical trial involving investigational agents
  • No prior surgical castration
  • Concurrent androgen deprivation for prostate cancer allowed provided it was started ≤ 3 months prior to initiation of study treatment
  • Concurrent anticoagulant treatment allowed
  • No other concurrent investigational drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00796458
Other Study ID Numbers  ICMJE GOUP-01/04
CDR0000626194 ( Registry Identifier: PDQ (Physician Data Query) )
EUDRACT 2004-003495-11
EU-20892
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE A.O.U. San Giovanni Battista di Torino, Italy
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Oscar Bertetto, MD Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
Investigator: Isabella Chiappino, MD A.O.U. San Giovanni Battista di Torino, Italy
PRS Account National Cancer Institute (NCI)
Verification Date November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP