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Compare the Value of Prophylactic Versus Therapeutic Breast Radiotherapy in CASODEX (COMART)
This study has been completed.
Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00590213
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Casodex 150mg
Procedure: Radiotherapy
Procedure: Haematology
Phase IV

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Bicalutamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: An Open Randomised Trial to Compare the Value of Prophylactic Versus Therapeutic Breast Radiotherapy in CASODEX Monotherapy Induced Gynaecomastia and/or Breast Pain in Prostate Cancer Patients

Further study details as provided by AstraZeneca:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 125
Study Start Date: June 2003
  Eligibility

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00590213

Locations
Turkey
Research Site
Adana, Turkey
Research Site
Ankara, Turkey
Research Site
Diyarbak?r, Turkey
Research Site
Edirne, Turkey
Research Site
Samsun, Turkey
Research Site
Istanbul, Turkey
Research Site
Izmir, Turkey
Research Site
Manisa, Turkey
Research Site
Eskisehir, Turkey
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Haluk Ozen, Prof Hacettepe Univ. Med. Fac
  More Information

Responsible Party: Turkey Clinical Study Information ( AstraZeneca )
Study ID Numbers: 7054TR/01
Study First Received: December 28, 2007
Last Updated: January 23, 2008
ClinicalTrials.gov Identifier: NCT00590213  
Health Authority: Turkey: Ministry of Health

Keywords provided by AstraZeneca:
Casodex
Prostate Cancer

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Bicalutamide
Urogenital Neoplasms
Pain
Genital Diseases, Male
Prostatic Neoplasms
Gynecomastia

Additional relevant MeSH terms:
Androgen Antagonists
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009