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

AstraZeneca

Status and phase

Completed

Phase 4

Conditions

Prostate Cancer

Treatments

Procedure: Haematology

Procedure: Radiotherapy

Drug: Casodex 150mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00590213

7054TR/01

Details and patient eligibility

About

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.

Enrollment

125 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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