Compare the Value of Prophylactic Versus Therapeutic Breast Radiotherapy in CASODEX

Condition(s) targeted: Prostate Cancer

Intervention: Casodex 150mg (Drug); Radiotherapy (Procedure); Haematology (Procedure)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Haluk Ozen, Prof, Principal Investigator, Affiliation: Hacettepe Univ. Med. Fac

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.

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

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

Starting date: June 2003
Last updated: January 23, 2008