NCT00668083

Brief Summary

Observational Retrospective trial on sequential hormonal therapy in patients with Prostate Cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

Shorter than P25 for all trials

Geographic Reach
1 country

12 active sites

Status
completed

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

September 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

December 10, 2010

Status Verified

December 1, 2010

Enrollment Period

1 month

First QC Date

April 24, 2008

Last Update Submit

December 9, 2010

Conditions

Prostate Cancer

Keywords

second lineProstate Cancerbicalutamidebiochemical relapse/progression in patients with Prostate Cancer treated with bicalutamide 150mg

Outcome Measures

Primary Outcomes (1)

  • Hormonal sensitivity to second line treatment for CaP after Bicalutamide

    six months

Secondary Outcomes (1)

  • median duration of second and third line treatments;

    six months

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

THIS IS A RETROSPECTIVE TRIAL THEREFORE CLINICAL DATA ARE FROM ARCHIVED CLINICAL RECORD OF PATIENTS WHO WERE ADMITTED IN THE HOSPITAL.

You may qualify if:

  • non metastatic Prostate Cancer
  • previous treatment with bicalutamide 150mg
  • biochemical relapse/progression

You may not qualify if:

  • use of other treatments for Prostate Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Research Site

Acquaviva delle Fonti, Italy

Location

Research Site

Ancona, Italy

Location

Research SIte

Florence, Italy

Location

Research Site

Matera, Italy

Location

Research Site

Messina, Italy

Location

Research Site

Milan, Italy

Location

Research Site

Monza, Italy

Location

Research Site

Napoli, Italy

Location

Research Site

Pisa, Italy

Location

Research Site

Portogruaro, Italy

Location

Research Site

Roma, Italy

Location

Research Site

Viareggio, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Davide Meani, MD

    AstraZeneca Medical Dept

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 24, 2008

First Posted

April 28, 2008

Study Start

September 1, 2007

Primary Completion

October 1, 2007

Study Completion

July 1, 2008

Last Updated

December 10, 2010

Record last verified: 2010-12

Locations

IT(12)