Bicalutamide Compared With Observation Followed by Bicalutamide Plus Either Goserelin or Orchiectomy in Treating Patients With Prostate Cancer - Full Text View

Sponsor:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00014586

Purpose

RATIONALE: Testosterone can stimulate the growth of cancer cells. Bicalutamide and goserelin may fight prostate cancer by reducing the production of testosterone. It is not yet known which hormone therapy regimen is most effective for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of bicalutamide with that of observation followed by bicalutamide plus either goserelin or orchiectomy for patients who have prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Drug: bicalutamide Drug: goserelin Procedure: orchiectomy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Randomized Phase III Step-Up Study On Initial Antiandrogen Monotherapy In Comparison With Watchful Waiting In Asymptomatic T1-3 Any G (Any Gleason) NO or Nx M0 Prostate Cancer Patients Without Local Treatment With Curative Intent

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Goserelin Bicalutamide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

January 2001

Detailed Description:

OBJECTIVES:

Compare the overall and cancer-specific survival of patients with prostate cancer treated with bicalutamide alone followed by bicalutamide with either goserelin or bilateral orchiectomy vs observation followed by bicalutamide with either goserelin or bilateral orchiectomy.
Compare the time to first and second clinical progression in patients treated with these regimens.
Compare the quality of life, including potency, of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, tumor differentiation grade (G3 or Gleason more than 6 vs other values), T category, comorbidity (i.e., chronic disease) (yes vs no), potency (yes vs no), type of chosen hormonal ablation (goserelin vs orchiectomy), PSA level (less than 10 ng/mL vs 10-20 ng/mL vs 20-100 ng/mL), and N status (N0 vs NX). Patients are randomized to one of two treatment arms.

Arm I: Patients receive oral bicalutamide once daily. At first symptomatic disease progression, patients also receive goserelin subcutaneously once every 28 or 84 days or undergo bilateral orchiectomy. At second disease progression, patients discontinue bicalutamide.
Arm II: Patients are observed until first symptomatic disease progression. At first disease progression, patients receive bicalutamide with either goserelin or bilateral orchiectomy as in arm I. Patients discontinue bicalutamide as in arm I.

Quality of life is assessed at baseline, every 6 months for 6 years, at each disease progression, and then annually thereafter.

Patients are followed annually.

PROJECTED ACCRUAL: Approximately 1266 patients (633 per treatment arm) will be accrued for this study within 5 years.

Eligibility

Ages Eligible for Study:	up to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed prostate cancer
- T1-3, any G (any Gleason), N0 or NX
High risk defined as G3 or Gleason more than 6 or PSA more than 20 ng/mL and unfit or unwilling to undergo local curative therapy OR
Low risk defined as G1-2 or Gleason less than 7 and PSA no more than 20 ng/mL and no prior local curative therapy
Asymptomatic (pain score of 0)
PSA no more than 100 ng/mL (no more than 25 times normal)
No metastatic disease by chest x-ray, bone scan (if PSA more than 10 ng/mL or 2.5 times normal), and pelvic CT (if chance of lymph node metastases is at least 5% by Partin tables)
No bone disease that would interfere with diagnosis of metastatic disease

PATIENT CHARACTERISTICS:

Age:

80 and under

Performance status:

WHO 0-2

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

No other malignancy within the past 5 years except adequately treated basal cell skin cancer
No psychological, personal, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00014586

Locations

Germany
Center of Operative Urology Bremen
Bremen, Germany, D-28277

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Investigators

Study Chair:

Gerald H.J. Mickisch, MD

Center of Operative Urology Bremen

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068560, EORTC-GU-30991
Study First Received:	April 10, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00014586 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I prostate cancer
stage II prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Goserelin
Urogenital Neoplasms

Genital Diseases, Male
Pharmacologic Actions
Androgen Antagonists
Neoplasms
Neoplasms by Site
Therapeutic Uses
Bicalutamide
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009