CMAB vs IMAB in Metastatic Prostate Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00255268
First received: October 26, 2005
Last updated: August 24, 2007
Last verified: August 2007
  Purpose

To evaluate the efficacy, safety and survival of two treatment regimens: Continuous Intermittent Maximum Androgen Blockade, using goserelin and bicalutamide in patients with prostate cancer. Primary endpoint is time to progression. Fifteen patients will be evaluated. QoL evaluation is also included.


Condition Intervention Phase
Metastatic Prostate Cancer
Drug: Goserelin
Drug: Bicalutamide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Longitudinal, Randomized, Open and Prospective Clinical Trial to Evaluate the Efficacy of Continuous vs Intermittent Maximum Androgen Blockade (CMAB vs IMAB) With Goserelin-Bicalutamide Combination in the Treatment of Hormonal naïve With Metastatic Prostate Cancer

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to progression

Secondary Outcome Measures:
  • Safety
  • Quality of Life

Estimated Enrollment: 15
Study Start Date: August 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological diagnosis of D2 of Adenocarcinoma,
  • Naivety to treatment
  • Valuable bone metastasis

Exclusion Criteria:

  • Hematological, liver or renal toxicity Grade IV
  • Severe and active infections
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255268

Locations
Mexico
Research Site
Metepec, Mexico
Research Site
Mexico City, Mexico
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Mexico Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00255268     History of Changes
Other Study ID Numbers: D6876L00010
Study First Received: October 26, 2005
Last Updated: August 24, 2007
Health Authority: Mexico: Ministry of Health

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bicalutamide
Goserelin
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on October 19, 2014