Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer

July 20, 2016 updated by: St. Luke's Hospital, Ireland

A Randomised Comparison of Short and Protracted Neoadjuvant Hormonal Therapy Prior to Radiation Therapy of High Risk Localized Prostate Cancer

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using triptorelin and flutamide may fight cancer by reducing the production of androgens. It is not yet known whether giving hormone therapy for 4 months is more effective than giving therapy for 8 months prior to radiation therapy for prostate cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of combination hormone therapy for 4 or 8 months followed by radiation therapy in treating patients with prostate cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Compare the efficacy of 4 months vs 8 months of luteinizing hormone-releasing hormone (LHRH) agonist therapy combined with antiandrogen therapy prior to radiotherapy, in terms of disease-free survival and overall survival, in patients with stage I-IV localized invasive prostate cancer.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. All patients receive triptorelin IM once a month and oral flutamide three times daily with meals. Patients randomized to arm I receive this therapy regimen for 4 months. Patients randomized to arm II receive this therapy regimen for 8 months. All patients then undergo radiotherapy 5 days a week for 7 weeks within 2 months of the last injection of triptorelin and within 1 month of the last oral flutamide tablet. Patients are followed every 3 months after radiotherapy.

PROJECTED ACCRUAL: A total of 276 patients (138 per treatment arm) will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

276

Phase

  • Phase 3

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
      • Cork, Ireland
        • Cork University Hospital
      • Donnegal, Ireland
        • Letterkenny Hospital
      • Dublin, Ireland, 9
        • Beaumont Hospital
      • Dublin, Ireland, 6
        • Saint Luke's Hospital
      • Dublin, Ireland, 7
        • Mater Misericordiae Hospital
      • Dublin, Ireland, 4
        • St. Vincent's Hospital
      • Dublin, Ireland, 8
        • Adelaide and Meath Hospital
      • Galway, Ireland
        • Galway University Hospital
      • Galway, Ireland
        • Bon Secours Hospital
      • Limerick, Ireland
        • Regional Hospital - Limerick
      • Sligo, Ireland
        • Sligo General
  • United Kingdom
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT8 8JR
        • Belfast City Hospital Trust Incorporating Belvoir Park 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 to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS: Histologically confirmed invasive adenocarcinoma of the prostate Stage I or II (PSA greater than 20 or Gleason score at least 7) OR Stage III or IV (any PSA, any Gleason) Histologically confirmed benign nodal status No distant metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior malignancy except nonmelanoma skin cancer No other uncontrolled illness that would prevent compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No prior or other concurrent hormonal therapy Radiotherapy: Not specified Surgery: No prior treatment other than transurethral prostatectomy No prior orchiectomy

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

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

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

Sponsor

St. Luke's Hospital, Ireland

Investigators

  • Study Chair: John Gerard Armstrong, MD, MB, MRCPI, Saint Luke's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 1998

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

December 8, 2003

First Posted (Estimate)

December 9, 2003

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 20, 2016

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066849
  • ICORG-97-01
  • EU-98060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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