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Proteomic Analysis of the Combined Hormonal Therapy and Radiation Therapy for Localized Prostate Cancer

18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Proteomic Analysis of the Combined Hormonal Therapy and Radiation Therapy for Localized Prostate Cancer


- Detect changes in serum and urine proteomic profiles that predict outcome in patients
with newly diagnosed localized prostate cancer treated with hormonal therapy and

- 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

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.

Inclusion 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/

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Changes in serum and urine proteomic profiles

Outcome Time Frame:

Ongoing until patient progression

Safety Issue:


Principal Investigator

John Gerard Armstrong, MD, MB, MRCPI

Investigator Role:

Principal Investigator

Investigator Affiliation:

Saint Luke's Hospital


Ireland: Health Information and Quality Authority

Study ID:




Start Date:

September 2005

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • Prostatic Neoplasms