Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments bicalutamide, releasing hormone agonist therapy, protein expression analysis, proteomic profiling, laboratory biomarker analysis, radiation therapy
Sponsor ICORG- All Ireland Cooperative Oncology Research Group
Start date September 2005
End date October 2012
Trial size 60 participants
Trial identifier NCT00955435, 06-15 ICORG, EU-20921, ICORG-06-15

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Changes in serum and urine proteomic profiles
time frame: Ongoing until patient progression
Prognostic and biochemical markers of early disease progression
time frame: Ongoing until patient progression
Protein expression and temporal alterations
time frame: Ongoing until patient progression
Molecular targets
time frame: Ongoing until patient progression

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title Proteomic Analysis of the Combined Hormonal Therapy and Radiation Therapy for Localized Prostate Cancer
Principal investigator John Gerard Armstrong, MD, MB, MRCPI
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. - Identify prognostic and biochemical markers of early disease progression in patients treated with this regimen. - Identify unique protein expression and temporal alterations, in these profiles, that facilitate understanding of the factors predicting relapse or toxicity. - Identify molecular signatures that allow identification of targets for therapeutic intervention. OUTLINE: This is a multicenter study. Patients receive induction hormones* (bicalutimide and releasing-hormone agonist) for approximately 4 months prior to starting radiotherapy. Patients then receive radiotherapy consisting of 74 Gy up to a maximum of 81 Gy to the prostate gland per standard treatment.NOTE: * Patients receiving short-term hormonal treatment for 4-8 months are eligible to participate in the trial. Blood and urine samples are collected at baseline, and periodically during and after induction therapy for proteomic analysis. After completion of study therapy, patients are followed up periodically for up to 3 years.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by ICORG- All Ireland Cooperative Oncology Research Group.