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Compare the Value of Prophylactic Versus Therapeutic Breast Radiotherapy in CASODEX (COMART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00590213
Recruitment Status : Completed
First Posted : January 10, 2008
Last Update Posted : January 25, 2008
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Casodex 150mg Procedure: Radiotherapy Procedure: Haematology Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2003

Resource links provided by the National Library of Medicine





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

Secondary Outcome Measures :
  1. To examine the tolerability of radiotherapy to male breast
  2. To examine the tolerability of Casodex 150mg in localized and locally advanced prostate cancer patients
  3. To examine the efficacy of Casodex 150mg in prostate cancer patients


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590213


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

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Responsible Party: AstraZeneca, Turkey Clinical Study Information
ClinicalTrials.gov Identifier: NCT00590213    
Other Study ID Numbers: 7054TR/01
First Posted: January 10, 2008    Key Record Dates
Last Update Posted: January 25, 2008
Last Verified: January 2008
Keywords provided by AstraZeneca:
Casodex
Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents