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Radiation Therapy in Treating Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00003290
Recruitment Status : Completed
First Posted : April 23, 2003
Last Update Posted : December 4, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Biological: gonadotrophin releasing hormone Radiation: radiation therapy Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomised Trial of High Dose Therapy in Localised Cancer of the Prostate Using Conformal Radiotherapy Techniques
Study Start Date : January 1998
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003290


Locations
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Sponsors and Collaborators
Medical Research Council
Investigators
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Study Chair: David P. Dearnaley, MD, FRCP, FRCR Royal Marsden NHS Foundation Trust
More Information
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Publications of Results:
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.

Other Publications:
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.

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ClinicalTrials.gov Identifier: NCT00003290    
Other Study ID Numbers: CDR0000066222
MRC-RT01
EU-98005
First Posted: April 23, 2003    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: July 2001
Keywords provided by National Cancer Institute (NCI):
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs