Prostate CancerNCT00955435
Study of Blood and Urine Samples in Patients With Newly Diagnosed Localized Prostate Cancer Treated With Hormone Therapy and Radiation Therapy. ICORG 06-15
An observational study of Prostate Cancer, run by Cancer Trials Ireland at 2 sites in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Non-interventional, Protein expression analysis and Proteomic profiling
- How many people
- 60 participants
- Where
- 2 sitesIreland
- Study dates
- Feb 2006to 6 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
Beacon Hospital
Dublin, 18
Saint Luke's Radiation Oncology Network
Dublin, 6
About this study
Official title: 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.
Read the 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 (per standard treatment). 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 5 years and yearly thereafter for the duration of the trial.
- Conditions
- Prostate Cancer
- Being tested
- Non-interventional, Protein expression analysis, Proteomic profiling, Laboratory biomarker analysis
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
Patients receive induction hormones* (bicalutimide and releasing-hormone agonist) for approximately 4 months prior to starting radiotherapy per standard treatment. Patients then receive radiotherapy consisting of 74 Gy up to a maximum of 81 Gy to the prostate gland per standard treatment.
Protein expression analysisGenetic
Proteomic profilingGenetic
Laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum and urine proteomic profiles
Measured: Ongoing until patient progression
Prognostic and biochemical markers of early disease progression
Measured: Ongoing until patient progression
Protein expression and temporal alterations
Measured: Ongoing until patient progression
Molecular targets
Measured: Ongoing until patient progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startFeb 2006
- Primary completion26 Jan 2026
- Study completion6 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- John Gerard Armstrong, MD, MB, MRCPI, Principal investigator, Saint Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955435
- Sponsor's protocol ID
- CTRIAL-IE (ICORG) 06-15
- Other IDs
- CTRIAL-IE (ICORG) 06-15, EU-20921
- Status last verified
- Oct 2026
- First submitted
- 7 Aug 2009
- Last updated
- 29 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic Analysis of the Combined Hormonal Therapy and Radiation Therapy for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT00955435
- Acronym / sponsor ID
- CTRIAL-IE (ICORG) 06-15
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Feb 2006 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 6 Aug 2026 (actual)
- First posted
- 10 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (per standard treatment). 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 5 years and yearly thereafter for the duration of the trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionalPatients receive induction hormones* (bicalutimide and releasing-hormone agonist) for approximately 4 months prior to starting radiotherapy per standard treatment. Patients then receive radiotherapy consisting of 74 Gy up to a maximum of 81 Gy to the prostate gland per standard treatment. | Other | – |
| Protein expression analysis | Genetic | – |
| Proteomic profiling | Genetic | – |
| Laboratory biomarker analysis | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Gerard Armstrong, MD, MB, MRCPI principal investigator
Saint Luke's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Cancer Trials Ireland at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in serum and urine proteomic profiles (time frame: Ongoing until patient progression). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.