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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
  Purpose

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.


Condition Intervention
Prostate Cancer Drug: bicalutamide Drug: releasing hormone agonist therapy Genetic: protein expression analysis Genetic: proteomic profiling Other: laboratory biomarker analysis Radiation: radiation therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Proteomic Analysis of the Combined Hormonal Therapy and Radiation Therapy for Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Cancer Trials Ireland:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: September 2005
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
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.
  • 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955435


Locations
Ireland
Beacon Hospital
Dublin, Ireland, 18
Saint Luke's Radiation Oncology Network
Dublin, Ireland, 6
Sponsors and Collaborators
Cancer Trials Ireland
Investigators
Principal Investigator: John Gerard Armstrong, MD, MB, MRCPI Saint Luke's Hospital
  More Information

Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT00955435     History of Changes
Other Study ID Numbers: CTRIAL-IE (ICORG) 06-15
EU-20921
First Submitted: August 7, 2009
First Posted: August 10, 2009
Last Update Posted: May 24, 2017
Last Verified: May 2017

Keywords provided by Cancer Trials Ireland:
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Bicalutamide
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents