Status:
UNKNOWN
Study of Blood and Urine Samples in Patients With Newly Diagnosed Localized Prostate Cancer Treated With Hormone Therapy and Radiation Therapy. ICORG 06-15
Lead Sponsor:
Cancer Trials Ireland
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Brief 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...
Detailed Description
OBJECTIVES: * Detect changes in serum and urine proteomic profiles that predict outcome in patients with newly diagnosed localized prostate cancer treated with hormonal therapy and radiotherapy. * Id...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age 18 years or over.
- Histologically confirmed invasive adenocarcinoma of the prostate (by TURP or TRUS).
- Localised prostate cancer with a Gleason score 7
- Short term hormonal treatment 4-8 months
- Performance status of KPS ≥ 60 / WHO 0-2
- Absence of distant metastases
- Exclusion criteria:
- The patient has previously received treatment for prostate cancer other than TURP/ TRUS
- The patient has had a bilateral orchidectomy
- The patient has previously received hormonal treatment for prostate cancer
- 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
- The patient has or had other co-existing malignancies within the past 5 years other than non- melanoma skin cancer
- Treatment with non-approved or investigational drug within 30 days before day one of the trial
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00955435
Start Date
February 1 2006
Last Update
February 18 2021
Active Locations (2)
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1
Beacon Hospital
Dublin, Ireland, 18
2
Saint Luke's Radiation Oncology Network
Dublin, Ireland, 6