NCT00590213

Brief Summary

The primary objective of this trial is to examine the value of prophylactic versus therapeutic breast radiotherapy in Casodex monotherapy induced gynaecomastia and/or breast pain. Patients will receive either prophylactic radiotherapy to the breast at a dose of 12Gy (as two fractions of 6 Gy in consecutives days), or will not receive any radiotherapy prior to commencing CASODEX 150mg monotherapy.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for phase_4 prostate-cancer

Geographic Reach
1 country

9 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

June 1, 2003

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 10, 2008

Completed
Last Updated

January 25, 2008

Status Verified

January 1, 2008

First QC Date

December 28, 2007

Last Update Submit

January 23, 2008

Conditions

Prostate Cancer

Keywords

CasodexProstate Cancer

Outcome Measures

Primary Outcomes (1)

  • To examine the value of prophylactic versus therapeutic breast radiotherapy in Casodex monotherapy induced gynaecomastia and/or breast pain

Secondary Outcomes (3)

  • To examine the tolerability of radiotherapy to male breast

  • To examine the tolerability of Casodex 150mg in localized and locally advanced prostate cancer patients

  • To examine the efficacy of Casodex 150mg in prostate cancer patients

Interventions

Casodex 150mgDRUG
RadiotherapyPROCEDURE
HaematologyPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Males patients aged 18 years or over on entry into the trial
  • Patients who have non-metastatic cancer that is confirmed by histology or cytology. This primary treatment should have been completed in the last 8 weeks
  • The stage should be T1b/T1c/T2/T3/T4 any N category
  • Paitents must have given written, fully informed consent to participate in the trial prior to any trial specific assessments being made
  • Be able and prepared to comply with trial procedures and restrictions
  • Have a life expectancy greater than 2 years

You may not qualify if:

  • Any known sensitivity to radiation therapy or any conditions which in the investigator's opinion may lead to radiation sensitivity
  • Patients with any concurrent malignancy (except for basal cell or TO-2 NO MO squamous cell carcinoma of the skin). History of previous malignancy or treatment for any cancer in the past 5 years
  • Previous history of mastectomy including a Webster operation or radiation therapy to the chest area
  • Any previous treatment with surgical or medical castration, anti-androgens, monotherapy or oestrogen therapy at any time
  • Any evidence of pre-existing gynaecomastia or breast pain
  • Patients with history or presence of testicular abnormalities (as CASODEX can potentially aggravate testicular tumours)
  • Patients with any concurrent disease or condition that in the opinion of the treating physician, would constitute a hazard for participation in this study or may interfere with the patient's ability to comply with the scheduled visits and assessments. This includes patients whose physical build would prevent reasonable assessment of gynaecomastia
  • Liver disease (bilirubin greater than 2.0mg/dL; AST/ALT greater than 2 times the upper limit or normal)
  • Patients taking the following drugs; terfenadine, cisapride, astemizole, cyclosporin, and warfarin are excluded from the trial due to the possibility of drug interaction
  • Patients with a known history of alcohol abuse
  • Concurrent treatment with any druges known to have high potential for causing gynaecomastia or breast pain, eg.Spironolactone, steroid therapy, cimetidine and neuroleptic agents.
  • Treatment with a new chemical entity within the previous 4 months or current participation in another clinical trial involving an investigational product
  • Patients considered by the investigator to be at risk of transmitting any infection through the body or other body fluids, including acquired immue dificiency syndrome (AIDS) other sexually transmitted diseases or hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Research Site

Adana, Turkey (Türkiye)

Location

Research Site

Ankara, Turkey (Türkiye)

Location

Research Site

Diyarbak?r, Turkey (Türkiye)

Location

Research Site

Edirne, Turkey (Türkiye)

Location

Research Site

Eskişehir, Turkey (Türkiye)

Location

Research Site

Istanbul, Turkey (Türkiye)

Location

Research Site

Izmir, Turkey (Türkiye)

Location

Research Site

Manisa, Turkey (Türkiye)

Location

Research Site

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamideRadiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Haluk Ozen, Prof

    Hacettepe Univ. Med. Fac

    PRINCIPAL INVESTIGATOR

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

December 28, 2007

First Posted

January 10, 2008

Study Start

June 1, 2003

Last Updated

January 25, 2008

Record last verified: 2008-01

Locations

TU(9)