NCT00233610

Brief Summary

The aim of the study is to investigate the efficacy of different dosing and scheduling of Nolvadex in preventing gynecomastia/mastalgia induced by Casodex 150 mg monotherapy in patients with prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P25-P50 for phase_3 prostate-cancer

Timeline
Completed

Started Dec 2003

Geographic Reach
1 country

11 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

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

January 27, 2011

Status Verified

January 1, 2011

Enrollment Period

3.8 years

First QC Date

October 4, 2005

Last Update Submit

January 25, 2011

Conditions

Prostate Cancer

Keywords

Casodex monotherapy

Outcome Measures

Primary Outcomes (1)

  • Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit.

Secondary Outcomes (1)

  • Sexual functioning, Quality of life.

Interventions

BicalutamideDRUG
TamoxifenDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed prostate cancer
  • Locally advanced prostate cancer patients suitable for Casodex 150 mg monotherapy

You may not qualify if:

  • Age \> 75 yrs
  • No metastatic disease (M1).
  • No presence of gynaecomastia and/or mastalgia at screening
  • No therapy with medications able to provoke gynaecomastia and/or mastalgia within 6 months of trial entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Bari, BA, Italy

Location

Research Site

Bologna, BO, Italy

Location

Research Site

Catania, CT, Italy

Location

Research Site

Bagno a Ripoli, FI, Italy

Location

Research Site

Florence, FI, Italy

Location

Research Site

Genova, GE, Italy

Location

Research Site

Pisa, PI, Italy

Location

Research Site

Parma, PR, Italy

Location

Research Site

Roma, Roma, Italy

Location

Research Site

Udine, UD, Italy

Location

Research Site

Como, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamideTamoxifen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Astra Zeneca

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 4, 2005

First Posted

October 6, 2005

Study Start

December 1, 2003

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

January 27, 2011

Record last verified: 2011-01

Locations

IT(11)