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

February 17, 2021 updated by: Cancer Trials Ireland

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.

Study Overview

Status

Unknown

Conditions

Prostate Cancer

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Ireland
- - Dublin, Ireland, 6
    - Saint Luke's Radiation Oncology Network
  - Dublin, Ireland, 18
    - Beacon Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

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.

Description

Inclusion criteria:

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

Exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Trials Ireland

Investigators

Principal Investigator: John Gerard Armstrong, MD, MB, MRCPI, Saint Luke's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2006

Study Registration Dates

First Submitted

August 7, 2009

First Submitted That Met QC Criteria