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

NCT00031889 | Completed Phase 2 DMC

• 2 other identifiers: SAKK 09/01EU-20139
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 12

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage IV prostate cancer; recurrent prostate cancer

Study Arms (2)

Arm I

ACTIVE COMPARATOR

Patients receive oral exemestane once daily

Drug: Exemestane

Arm II

ACTIVE COMPARATOR

Patients receive exemestane as in arm I and oral bicalutamide once daily

Drug: Exemestane+bicalutamide

Interventions

Exemestane DRUG

Exemestane

Arm I

Exemestane+bicalutamide DRUG

Exemestane as in arm I and oral bicalutamide once daily

Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (12)

Kantonspital Aarau

Aarau, 5001, Switzerland

Location

University Hospital

Basel, CH-4031, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Spitalzentrum Biel

Biel, CH-2500, Switzerland

Location

Kantonsspital Bruderholz

Bruderholz, CH-4101, Switzerland

Location

Ratisches Kantons und Regionalspital

Chur, CH-7000, Switzerland

Location

Clinique De Genolier

Genolier, Ch-1272, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Istituto Oncologico della Svizzera Italiana

Lugano, CH-6900, Switzerland

Location

Ospedale Beata Vergine

Mendrisio, CH-6850, Switzerland

Location

Institut Central des Hopitaux Valaisans

Sion, CH1951, Switzerland

Location

Universitaetsspital

Zurich, CH-8091, Switzerland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

exemestane

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Marco Bonomo, MD

  Ospedale Beata Vergine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2002
• First Posted: July 1, 2003
• Study Start: August 1, 2001
• Primary Completion: June 1, 2002
• Study Completion: June 1, 2002
• Last Updated: May 15, 2012

Record last verified: 2012-05

Locations

CH (12)