From Medicalnewstoday.com

07 Nov. 2005

New data resulting from the 3rd analysis of the Early Prostate Cancer (EPC)
Trial Programme confirm that bicalutamide 150mg improves the chance of
survival by more than one third (35 per cent) in men with locally advanced
prostate cancer (when the disease has spread into the capsule of the
prostate or through the prostate into the surrounding tissue) when given as
adjuvant to radiotherapy, compared to radiotherapy alone. Bicalutamide 150mg
is the only anti-androgen for which this has been shown.1

Also the data from the largest ever treatment study in prostate cancer show
that in locally advanced disease, bicalutamide 150mg adjuvant to
radiotherapy or radical prostatectomy reduces the risk of disease
progression by 31 per cent, leading to a significant survival benefit of 35
per cent when used as adjuvant to radiotherapy. In addition, in men with
locally advanced prostate cancer, when bicalutamide 150mg was given as
monotherapy there was a 40 per cent reduction in risk, which extended
survival free of progression by a median of 2.9 years, showing a trend
towards improved survival.1

Commenting on the data, Dr Heather Payne, Consultant in Clinical Oncology,
Middlesex Hospital, London stated: "A diagnosis of prostate cancer is truly
devastating for the patient. A treatment that both extends a patient's life
and delays the recurrence of the disease whilst maintaining quality of life
is the ultimate goal when managing this condition. This new data from the
EPC Trial Programme demonstrates that bicalutamide 150mg meets these vital
needs and will have this effect for men with locally advanced prostate
cancer."

Results also confirm that treatment with bicalutamide 150mg significantly
reduces the risk of bone metastases by 36 per cent in men with locally
advanced prostate cancer compared to watchful waiting, and by 23 per cent
when added to radiotherapy or radical prostatectomy alone.1 Bone metastases
are a symptom of disease progression and can include bone and back pain that
can cause difficulty in walking and carrying out other daily activities. In
more advanced cases, bone metastases can lead to spinal cord compression. By
delaying disease progression, bicalutamide 150mg helps men with locally
advanced prostate cancer to maintain an active lifestyle.

Patients with locally advanced prostate cancer have a significant risk of
their disease progressing, seriously impacting quality of life. Therefore,
therapies that improve progression-free survival whilst allowing patients to
maintain a normal lifestyle are vital in managing the disease. In addition
to improving progression-free survival, bicalutamide 150mg alone
demonstrates equal efficacy to castration and provides patients with
significant quality of life benefits. Compared with castration, bicalutamide
150mg provides better maintenance of physical capacity and sexual
interest.2, Bicalutamide 150mg maintains bone mineral density, which is lost
with castration and is associated with an increased risk of fractures.

The EPC Trial Programme has followed 8,113 patients for an average of 7.4
years in 23 different countries. Patients will continue to be followed up
for both disease progression and survival for a minimum period of ten years
after the last patient was enrolled into the study.

The 3rd analysis of the EPC Programme gives additional confirmation that
bicalutamide 150mg is a proven treatment option for men with locally
advanced prostate cancer delaying disease progression.

In the UK, bicalutamide (Casodex) 150mg is indicated for patients with
locally advanced prostate cancer (T3-T4, any N, MO; T1-T2, N+, MO).
Bicalutamide (Casodex) 150mg is indicated as immediate therapy either alone
or as adjuvant to treatment by radical prostatectomy or radiotherapy.
Bicalutamide (Casodex) 150mg is also indicated for the management of
patients with locally advanced, non-metastatic prostate cancer for whom
surgical castration or other medical intervention is not considered
appropriate or acceptable.

- When the prostate cancer has spread into the capsule of the prostate or
through the prostate into the surrounding tissue, it is described as being
'locally advanced'.

- Bicalutamide (Casodex) 150mg is the leading anti-androgen in the locally
advanced prostate cancer market (disease that has spread to organs adjacent
to the prostate gland).

- Bicalutamide (Casodex) 150mg is a non-steroidal anti-androgen, which
blocks the action of androgens, such as testosterone and prevents the
stimulation of prostate tumour growth.

- Bicalutamide (Casodex) 50mg is used as a combination treatment (with
surgical or medical castration) for advanced prostate cancer

- Watchful waiting is a type of prostate cancer management where no surgical
or medical intervention is pursued immediately, but the prostate cancer is
watched by the doctor using regular PSA blood tests and digital rectal
examinations. Active treatments are delayed until the cancer produces
troublesome symptoms. In watchful waiting, the doctor balances the impact of
treatments upon a patient's quality of life against the symptoms produced by
the disease.

- Prostate cancer is the most common cancer to be found in elderly men in
the UK. Over 30,000 men in the UK alone are diagnosed with prostate cancer
each year and prostate cancer has overtaken lung cancer to become the most
common cancer for men in the UK. Prostate cancer is the second biggest cause
of death from cancer in men in the UK with around 10,000 deaths each year.

Dan