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

NCT00014586 | Terminated Phase 3

• 2 other identifiers: EORTC-30991EORTC-GU-30991
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer

Interventions

bicalutamide DRUG

goserelin acetate DRUG

orchiectomy PROCEDURE

Eligibility Criteria

• Age: Up to 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (1)

Center of Operative Urology Bremen

Bremen, D-28277, Germany

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide; Goserelin; Orchiectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Castration; Endocrine Surgical Procedures; Surgical Procedures, Operative; Urogenital Surgical Procedures; Urologic Surgical Procedures, Male; Urologic Surgical Procedures

Study Officials

• Gerald H.J. Mickisch, MD

  Center of Operative Urology Bremen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2001
• First Posted: January 27, 2003
• Study Start: January 1, 2001
• Primary Completion: February 1, 2003
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

DE (1)