Overview

Study of Blood and Urine Samples in Patients With Newly Diagnosed Localized Prostate Cancer Treated With Hormone Therapy and Radiation Therapy. ICORG 06-15

Status:
Active, not recruiting

Trial end date:
0000-00-00

Target enrollment:
60

Participant gender:
Male

Summary

RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This clinical trial is studying blood and urine samples in patients with newly diagnosed localized prostate cancer treated with hormone therapy and radiation therapy.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Cancer Trials Ireland

Treatments:

Bicalutamide
Hormones

Last Updated:

2016-02-12

Criteria

Inclusion criteria:

1. Age 18 years or over.

2. Histologically confirmed invasive adenocarcinoma of the prostate (by TURP or TRUS).

3. Localised prostate cancer with a Gleason score 7

4. Short term hormonal treatment 4-8 months

5. Performance status of KPS ≥ 60 / WHO 0-2

6. Absence of distant metastases

Exclusion criteria:

1. The patient has previously received treatment for prostate cancer other than TURP/
TRUS

2. The patient has had a bilateral orchidectomy

3. The patient has previously received hormonal treatment for prostate cancer

4. Evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the patient to participate in the trial. In the opinion of the
investigator, any evidence of severe or uncontrolled systematic disease (e.g.
unstable or uncompensated respiratory, cardiac, hepatic or renal disease

5. The patient has or had other co-existing malignancies within the past 5 years other
than non- melanoma skin cancer

6. Treatment with non-approved or investigational drug within 30 days before day one of
the trial