A Randomized Phase II Trial of Exemestane With and Without Bicalutamide as Second Line Therapy After Failure of Androgen Suppression in Advanced Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

A Randomized Phase II Trial of Exemestane With and Without Bicalutamide as Second Line Therapy After Failure of Androgen Suppression in Advanced Prostate Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Marco Bonomo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ospedale Beata Vergine

Authority:

Switzerland: Swissmedic

Study ID:

SAKK 09/01

NCT ID:

NCT00031889

Start Date:

August 2001

Completion Date:

June 2002

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

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