Radiation Therapy in Treating Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003290
First received: November 1, 1999
Last updated: December 3, 2013
Last verified: July 2001
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether standard radiation therapy is more effective than high-dose radiation therapy in treating patients with prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation therapy with that of high-dose radiation therapy in treating patients with stage II or stage III prostate cancer.


Condition Intervention Phase
Prostate Cancer
Biological: gonadotrophin releasing hormone
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomised Trial of High Dose Therapy in Localised Cancer of the Prostate Using Conformal Radiotherapy Techniques

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 800
Study Start Date: January 1998
Study Completion Date: August 2004
Detailed Description:

OBJECTIVES:

  • Compare local tumor control in patients with stage II or III prostate cancer treated with neoadjuvant androgen deprivation therapy with standard vs high-dose conformal radiotherapy.
  • Compare the incidence of biochemical failure (prostate-specific antigen (PSA) greater than 2 ng/mL at 6 or more months after initiation of radiotherapy and PSA rising from nadir level by at least 50%), development of metastases, and survival in patients treated with these regimens.
  • Compare the acute and late radiation-induced side effects of these regimens in this patient population.
  • Compare aspects of quality of life, health economics, models of normal tissue, and tumor control in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prostate-specific antigen, T stage, and Gleason score. Patients are randomized to one of two treatment arms.

All patients receive neoadjuvant androgen deprivation with luteinizing hormone-releasing hormone agonists every 4 weeks beginning 3-6 months before initiation of radiotherapy and continuing until completion of radiotherapy.

  • Arm I: Patients undergo standard conformal radiotherapy for 6.5 weeks.
  • Arm II: Patients undergo high-dose conformal radiotherapy for 7.5 weeks. Quality of life is assessed at baseline, every 6 months for 2 years, and then annually thereafter.

Patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer

    • T1b-T3a, N0, M0 (stage II or III)
  • Prostate-specific antigen at least 50 ng/mL

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC greater than 4,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 11 g/dL

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No significant past medical history that would preclude radical radiotherapy
  • No condition that would preclude standard radiotherapy
  • No hip prosthesis

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • No prior androgen deprivation therapy

Radiotherapy:

  • No prior pelvic radiotherapy

Surgery:

  • No prior radical prostatectomy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003290

Locations
South Africa
Groote Schuur Hospital, Cape Town
Cape Town, South Africa, 7925
United Kingdom
University of Birmingham
Birmingham, England, United Kingdom, B15 2TT
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
Bristol Royal Hospital for Children
Bristol, England, United Kingdom, BS2 8BJ
Derbyshire Royal Infirmary
Derby, England, United Kingdom, DE1 2QY
Cookridge Hospital
Leeds, England, United Kingdom, LS16 6QB
University Hospitals of Leicester
Leicester, England, United Kingdom, LE1 5WW
Middlesex Hospital- Meyerstein Institute
London, England, United Kingdom, WIT 3AA
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom, M20 4BX
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom, L63 4JY
Newcastle General Hospital
Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Norfolk & Norwich Hospital
Norwich, England, United Kingdom, NR1 3SR
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Royal Marsden Hospital
Sutton, England, United Kingdom, SM2 5PT
Southend NHS Trust Hospital
Westcliff-On-Sea, England, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Royal Preston Hospital
Preston, United Kingdom, PR2 9HT
Sponsors and Collaborators
Medical Research Council
Investigators
Study Chair: David P. Dearnaley, MD, FRCP, FRCR Royal Marsden NHS Foundation Trust
  More Information

Additional Information:
Publications:
Stephen M, Helen T, Matthew S, et al.: Evaluating the relationship between erectile dysfunction and dose received by the penile bulb in patients undergoing conformal radiotherapy for prostate cancer: analysis of data from the MRC RT01 dose escalation trial (ISRCTN47772397). [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-209, S126, 2005.
Stephens RJ, Cowan R, Dearnaley DP, et al.: The effect of hormone therapy on the quality of life of men with locally advanced prostate cancer (based on data from the MRC RT01 randomised trial (ISRCTN 47772397)). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1665, 414, 2003.
van As N, South C, Naismith O, et al.: Radiotherapy planning in UK phase III trials of dose-escalated (MRC RT01) and high-dose hypofractionated radiotherapy (CHHIP) in prostate cancer. [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-98, 2006.

ClinicalTrials.gov Identifier: NCT00003290     History of Changes
Other Study ID Numbers: CDR0000066222, MRC-RT01, EU-98005
Study First Received: November 1, 1999
Last Updated: December 3, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on October 16, 2014