Know Cancer

or
forgot password

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


Phase 4
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Haluk Ozen, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hacettepe Univ. Med. Fac

Authority:

Turkey: Ministry of Health

Study ID:

7054TR/01

NCT ID:

NCT00590213

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Casodex
  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location