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

This study has been completed.
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research Identifier:
First received: March 8, 2002
Last updated: May 14, 2012
Last verified: May 2012

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 Intervention Phase
Prostate Cancer
Drug: Exemestane
Drug: Exemestane+bicalutamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Swiss Group for Clinical Cancer Research:

Enrollment: 5
Study Start Date: August 2001
Study Completion Date: June 2002
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients receive oral exemestane once daily
Drug: 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

Detailed Description:


  • 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.


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


  • 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



  • 18 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified


  • 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


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


  • Creatinine no greater than 1.5 times ULN


  • 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


Biologic therapy:

  • No prior antibody or gene therapy


  • No prior cytostatic agents

Endocrine therapy:

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


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


  • See Disease Characteristics


  • At least 4 weeks since prior investigational drugs
  Contacts and Locations
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Please refer to this study by its identifier: NCT00031889

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
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Study Chair: Marco Bonomo, MD Ospedale Beata Vergine
  More Information

Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT00031889     History of Changes
Other Study ID Numbers: SAKK 09/01
Study First Received: March 8, 2002
Last Updated: May 14, 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
Genital Diseases, Male
Prostatic Diseases
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists processed this record on May 25, 2017