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

NCT00955435 | Unknown

• 2 other identifiers: CTRIAL-IE (ICORG) 06-15EU-20921
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (4)

• Changes in serum and urine proteomic profiles

  Ongoing until patient progression

• Prognostic and biochemical markers of early disease progression

  Ongoing until patient progression

• Protein expression and temporal alterations

  Ongoing until patient progression

• Molecular targets

  Ongoing until patient progression

Interventions

Non-interventional OTHER

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 analysis GENETIC

Proteomic profiling GENETIC

Laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Trials Ireland: lead

Study Sites (2)

Beacon Hospital

Dublin, 18, Ireland

Location

Saint Luke's Radiation Oncology Network

Dublin, 6, Ireland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• John Gerard Armstrong, MD, MB, MRCPI

  Saint Luke's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2009
• First Posted: August 10, 2009
• Study Start: February 1, 2006
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

IE (2)