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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00955435
First Posted: August 10, 2009
Last Update Posted: May 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cancer Trials Ireland
August 7, 2009
August 10, 2009
May 24, 2017
September 2005
October 2012   (Final data collection date for primary outcome 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 ]
  • Changes in serum and urine proteomic profiles
  • Prognostic and biochemical markers of early disease progression
  • Protein expression and temporal alterations
  • Molecular targets
Complete list of historical versions of study NCT00955435 on ClinicalTrials.gov Archive Site
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Study of Blood and Urine Samples in Patients With Newly Diagnosed Localized Prostate Cancer Treated With Hormone Therapy and Radiation Therapy. ICORG 06-15
Proteomic Analysis of the Combined Hormonal Therapy and Radiation Therapy for Localized Prostate Cancer

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients diagnosed with localised prostate cancer who will receive radiation therapy plus hormonal therapy, for 4 - 8 months, are eligible for the trial. Patients will be eligible to participate in the trial provided they have not received prior therapy for their prostate cancer. It is planned that 60 patients will participate in the research study. All patients will receive approx 4 months of induction hormone therapy (LHRH agonist and Bicalutamide) prior to starting radiotherapy treatment.
Prostate Cancer
  • Drug: bicalutamide
  • Drug: releasing hormone agonist therapy
  • Genetic: protein expression analysis
  • Genetic: proteomic profiling
  • Other: laboratory biomarker analysis
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
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October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Ireland
 
 
NCT00955435
CTRIAL-IE (ICORG) 06-15
CTRIAL-IE (ICORG) 06-15
EU-20921
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Cancer Trials Ireland
Cancer Trials Ireland
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Principal Investigator: John Gerard Armstrong, MD, MB, MRCPI Saint Luke's Hospital
Cancer Trials Ireland
May 2017