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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Exemestane
Exemestane+bicalutamide
Sponsored by
Swiss Group for Clinical Cancer Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kantonspital Aarau
  • University Hospital
  • Inselspital, Bern
  • Spitalzentrum Biel
  • Kantonsspital Bruderholz
  • Ratisches Kantons und Regionalspital
  • Clinique De Genolier
  • Centre Hospitalier Universitaire Vaudois
  • Istituto Oncologico della Svizzera Italiana
  • Ospedale Beata Vergine
  • Institut Central des Hopitaux Valaisans
  • Universitaetsspital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm I

Arm II

Arm Description

Patients receive oral exemestane once daily

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 8, 2002
Last Updated
May 14, 2012
Sponsor
Swiss Group for Clinical Cancer Research
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1. Study Identification

Unique Protocol Identification Number
NCT00031889
Brief Title
Exemestane With or Without Bicalutamide in Treating Patients With Stage IV Prostate Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
June 2002 (Actual)
Study Completion Date
June 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Group for Clinical Cancer Research

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Active Comparator
Arm Description
Patients receive oral exemestane once daily
Arm Title
Arm II
Arm Type
Active Comparator
Arm Description
Patients receive exemestane as in arm I and oral bicalutamide once daily
Intervention Type
Drug
Intervention Name(s)
Exemestane
Intervention Description
Exemestane
Intervention Type
Drug
Intervention Name(s)
Exemestane+bicalutamide
Intervention Description
Exemestane as in arm I and oral bicalutamide once daily

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Bonomo, MD
Organizational Affiliation
Ospedale Beata Vergine
Official's Role
Study Chair
Facility Information:
Facility Name
Kantonspital Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
University Hospital
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Inselspital, Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Spitalzentrum Biel
City
Biel
ZIP/Postal Code
CH-2500
Country
Switzerland
Facility Name
Kantonsspital Bruderholz
City
Bruderholz
ZIP/Postal Code
CH-4101
Country
Switzerland
Facility Name
Ratisches Kantons und Regionalspital
City
Chur
ZIP/Postal Code
CH-7000
Country
Switzerland
Facility Name
Clinique De Genolier
City
Genolier
ZIP/Postal Code
Ch-1272
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Istituto Oncologico della Svizzera Italiana
City
Lugano
ZIP/Postal Code
CH-6900
Country
Switzerland
Facility Name
Ospedale Beata Vergine
City
Mendrisio
ZIP/Postal Code
CH-6850
Country
Switzerland
Facility Name
Institut Central des Hopitaux Valaisans
City
Sion
ZIP/Postal Code
CH1951
Country
Switzerland
Facility Name
Universitaetsspital
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland

12. IPD Sharing Statement

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

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