NCT00255268

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2005

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 18, 2005

Completed
Last Updated

August 28, 2007

Status Verified

August 1, 2007

First QC Date

October 26, 2005

Last Update Submit

August 24, 2007

Conditions

Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Time to progression

Secondary Outcomes (2)

  • Safety

  • Quality of Life

Interventions

GoserelinDRUG
BicalutamideDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Hematological, liver or renal toxicity Grade IV
  • Severe and active infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Metepec, Mexico

Location

Research Site

Mexico City, Mexico

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Goserelinbicalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • AstraZeneca Mexico Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 26, 2005

First Posted

November 18, 2005

Study Start

August 1, 2004

Last Updated

August 28, 2007

Record last verified: 2007-08

Locations

ME(2)