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Exemestane With or Without Bicalutamide in Treating Patients With Stage IV Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00031889
Recruitment Status : Completed
First Posted : July 1, 2003
Last Update Posted : May 15, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using exemestane plus bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if exemestane is more effective with or without bicalutamide in treating prostate cancer.

PURPOSE: Randomized phase II trial to study the effectiveness of exemestane with or without bicalutamide in treating patients who have stage IV prostate cancer that has been previously treated with hormone therapy or surgery.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Exemestane Drug: Exemestane+bicalutamide Phase 2

Detailed Description:

OBJECTIVES:

  • Compare the efficacy and tolerability of exemestane with or without bicalutamide as second-line therapy after failure of androgen suppression (luteinizing hormone-releasing hormone agonist or orchiectomy) in patients with stage IV prostate cancer.
  • Determine the potential antagonistic effect of the weak androgen action of exemestane when combined with bicalutamide in these patients.
  • Compare the quality of life (QOL) in patients treated with these regimens.
  • Correlate prostate-specific antigen response and data of QOL, including scores for pain intensity and analgesic consumption, in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs 1-2), pain (none or mild vs moderate or severe), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral exemestane once daily.
  • Arm II: Patients receive exemestane as in arm I and oral bicalutamide once daily.

Treatment in both arms continues every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.

Quality of life and pain are assessed at baseline, on day 1 of course 2 and any subsequent courses, and at disease progression or treatment failure (if applicable).

Patients are followed monthly until disease progression.

PROJECTED ACCRUAL: A total of 20-62 patients (10-31 per treatment arm) will be accrued for this study.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Exemestane With and Without Bicalutamide as Second Line Therapy After Failure of Androgen Suppression in Advanced Prostate Cancer
Study Start Date : August 2001
Primary Completion Date : June 2002
Study Completion Date : June 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Arm I
Patients receive oral exemestane once daily
Drug: Exemestane
Exemestane
Active Comparator: Arm II
Patients receive exemestane as in arm I and oral bicalutamide once daily
Drug: Exemestane+bicalutamide
Exemestane as in arm I and oral bicalutamide once daily


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed stage IV adenocarcinoma of the prostate
  • Documented disease progression based on prostate-specific antigen (PSA) progression during first-line androgen suppression (luteinizing hormone-releasing hormone agonist or orchiectomy)

    • PSA progression is defined by the following:

      • Interval of at least 1 week between reference value (time point value 1) and the next PSA level (time point value 2)
      • PSA at time point value 3 is greater than PSA at time point value 2 OR
      • PSA at time point value 3 is not greater than PSA at time point value 2, but PSA at time point value 4 is greater than PSA at time point value 2
  • PSA at least 5 ng/mL
  • Must continue primary androgen suppression if no prior surgical castration
  • No known leptomeningeal or brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,500/mm^3
  • Neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Other:

  • No acute concurrent severe infection
  • No other concurrent significant disease that would preclude study therapy
  • No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior antibody or gene therapy

Chemotherapy:

  • No prior cytostatic agents

Endocrine therapy:

  • See Disease Characteristics
  • No prior estramustine
  • No prior antiandrogens (e.g., bicalutamide)
  • No concurrent estrogen-containing medicine

Radiotherapy:

  • More than 4 weeks since prior radiotherapy
  • No concurrent radiotherapy to more than 1 field

Surgery:

  • See Disease Characteristics

Other:

  • At least 4 weeks since prior investigational drugs
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031889


Locations
Switzerland
Kantonspital Aarau
Aarau, Switzerland, 5001
University Hospital
Basel, Switzerland, CH-4031
Inselspital, Bern
Bern, Switzerland, CH-3010
Spitalzentrum Biel
Biel, Switzerland, CH-2500
Kantonsspital Bruderholz
Bruderholz, Switzerland, CH-4101
Ratisches Kantons und Regionalspital
Chur, Switzerland, CH-7000
Clinique De Genolier
Genolier, Switzerland, Ch-1272
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Istituto Oncologico della Svizzera Italiana
Lugano, Switzerland, CH-6900
Ospedale Beata Vergine
Mendrisio, Switzerland, CH-6850
Institut Central des Hopitaux Valaisans
Sion, Switzerland, CH1951
Universitaetsspital
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Study Chair: Marco Bonomo, MD Ospedale Beata Vergine
More Information

Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00031889     History of Changes
Other Study ID Numbers: SAKK 09/01
EU-20139
First Posted: July 1, 2003    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012

Keywords provided by Swiss Group for Clinical Cancer Research:
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Exemestane
Bicalutamide
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgen Antagonists