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Prostate CancerPhase 3NCT00003290

Radiation Therapy in Treating Patients With Prostate Cancer

A Phase 3 study testing gonadotrophin releasing hormone and radiation therapy in people with Prostate Cancer, run by Medical Research Council at 19 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, men only
Conditions the study is for
Prostate Cancer
What is being tested?
gonadotrophin releasing hormone and radiation therapy
Type of treatment
Surgery or procedure
How many people
800 participants
Where
19 sitesin 2 countries
Study dates
Jan 1998to Aug 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

United Kingdom18 sites

  • University of Birmingham

    Birmingham, England, B15 2TT

  • Bristol Royal Hospital for Children

    Bristol, England, BS2 8BJ

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

  • Derbyshire Royal Infirmary

    Derby, England, DE1 2QY

  • Royal Hospital for Sick Children

    Edinburgh, Scotland

  • Beatson Oncology Centre

    Glasgow, Scotland, G11 6NT

  • Cookridge Hospital

    Leeds, England, LS16 6QB

  • University Hospitals of Leicester

    Leicester, England, LE1 5WW

  • Middlesex Hospital- Meyerstein Institute

    London, England, WIT 3AA

  • Christie Hospital N.H.S. Trust

    Manchester, England, M20 4BX

  • Clatterbridge Centre for Oncology NHS Trust

    Merseyside, England, L63 4JY

  • Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

  • Mount Vernon Hospital

    Northwood, England, HA6 2RN

  • Norfolk & Norwich Hospital

    Norwich, England, NR1 3SR

  • Oxford Radcliffe Hospital

    Oxford, England, 0X3 9DU

  • Royal Preston Hospital

    Preston, PR2 9HT

  • Royal Marsden Hospital

    Sutton, England, SM2 5PT

  • Southend NHS Trust Hospital

    Westcliff-on-Sea, England

Other trials in United Kingdom

South Africa1 site

  • Groote Schuur Hospital, Cape Town

    Cape Town, 7925

Other trials in South Africa

About this study

Official title: A Randomised Trial of High Dose Therapy in Localised Cancer of the Prostate Using Conformal Radiotherapy Techniques

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
gonadotrophin releasing hormone, radiation therapy
Keywords
stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gonadotrophin releasing hormoneBiological

  • radiation therapyRadiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2003 (estimated)
  2. Study startJan 1998
  3. Study completionAug 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003290
Sponsor's protocol ID
CDR0000066222
Other IDs
MRC-RT01, EU-98005
Status last verified
Jul 2001
First submitted
1 Nov 1999
Last updated
4 Dec 2013
Results posted
No

Publications

  • South CP, Khoo VS, Naismith O, Norman A, Dearnaley DP. A comparison of treatment planning techniques used in two randomised UK external beam radiotherapy trials for localised prostate cancer. Clin Oncol (R Coll Radiol). 2008 Feb;20(1):15-21. doi: 10.1016/j.clon.2007.10.012. Epub 2007 Dec 3.

    PubMed 18054471

  • 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.

  • Mayles WP, Moore AR, Aird EG, Bidmead AM, Dearnaley DP, Griffiths SE, Warrington AP; RT01 collaborators. Questionnaire based quality assurance for the RT01 trial of dose escalation in conformal radiotherapy for prostate cancer (ISRCTN 47772397). Radiother Oncol. 2004 Nov;73(2):199-207. doi: 10.1016/j.radonc.2004.08.017.

    PubMed 15622611

  • Sydes MR, Stephens RJ, Moore AR, Aird EG, Bidmead AM, Fallowfield LJ, Graham J, Griffiths S, Mayles WP, McGuire A, Stanley S, Warrington AP, Dearnaley DP; RT01 collaborators. Implementing the UK Medical Research Council (MRC) RT01 trial (ISRCTN 47772397): methods and practicalities of a randomised controlled trial of conformal radiotherapy in men with localised prostate cancer. Radiother Oncol. 2004 Aug;72(2):199-211. doi: 10.1016/j.radonc.2004.04.007.

    PubMed 15297138

  • Gulliford SL, Partridge M, Sydes MR, Webb S, Evans PM, Dearnaley DP. Parameters for the Lyman Kutcher Burman (LKB) model of Normal Tissue Complication Probability (NTCP) for specific rectal complications observed in clinical practise. Radiother Oncol. 2012 Mar;102(3):347-51. doi: 10.1016/j.radonc.2011.10.022. Epub 2011 Nov 25.

    PubMed 22119373

  • Barnett GC, De Meerleer G, Gulliford SL, Sydes MR, Elliott RM, Dearnaley DP. The impact of clinical factors on the development of late radiation toxicity: results from the Medical Research Council RT01 trial (ISRCTN47772397). Clin Oncol (R Coll Radiol). 2011 Nov;23(9):613-24. doi: 10.1016/j.clon.2011.03.001. Epub 2011 Apr 5.

    PubMed 21470834

  • Gulliford SL, Foo K, Morgan RC, Aird EG, Bidmead AM, Critchley H, Evans PM, Gianolini S, Mayles WP, Moore AR, Sanchez-Nieto B, Partridge M, Sydes MR, Webb S, Dearnaley DP. Dose-volume constraints to reduce rectal side effects from prostate radiotherapy: evidence from MRC RT01 Trial ISRCTN 47772397. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):747-54. doi: 10.1016/j.ijrobp.2009.02.025. Epub 2009 Jun 18.

    PubMed 19540054

  • Syndikus I, Morgan RC, Sydes MR, Graham JD, Dearnaley DP; MRC RT01 collaborators. Late gastrointestinal toxicity after dose-escalated conformal radiotherapy for early prostate cancer: results from the UK Medical Research Council RT01 trial (ISRCTN47772397). Int J Radiat Oncol Biol Phys. 2010 Jul 1;77(3):773-83. doi: 10.1016/j.ijrobp.2009.05.052. Epub 2009 Oct 14.

    PubMed 19836155

  • Stanley S, Griffiths S, Sydes MR, Moore AR, Syndikus I, Dearnaley DP; RT01 Radiographer Trial Implementation Group. Accuracy and reproducibility of conformal radiotherapy using data from a randomised controlled trial of conformal radiotherapy in prostate cancer (MRC RT01, ISRCTN47772397). Clin Oncol (R Coll Radiol). 2008 Oct;20(8):582-90. doi: 10.1016/j.clon.2008.04.019. Epub 2008 Jun 18.

    PubMed 18565744

  • Dearnaley DP, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA, Huddart RA, Jose CC, Matthews JH, Millar J, Moore AR, Morgan RC, Russell JM, Scrase CD, Stephens RJ, Syndikus I, Parmar MK; RT01 collaborators. Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2007 Jun;8(6):475-87. doi: 10.1016/S1470-2045(07)70143-2.

    PubMed 17482880

  • Dearnaley DP, Sydes MR, Langley RE, Graham JD, Huddart RA, Syndikus I, Matthews JH, Scrase CD, Jose CC, Logue J, Stephens RJ; RT01 Collaborators. The early toxicity of escalated versus standard dose conformal radiotherapy with neo-adjuvant androgen suppression for patients with localised prostate cancer: results from the MRC RT01 trial (ISRCTN47772397). Radiother Oncol. 2007 Apr;83(1):31-41. doi: 10.1016/j.radonc.2007.02.014. Epub 2007 Mar 27.

    PubMed 17391791

  • Mangar SA, Sydes MR, Tucker HL, Coffey J, Sohaib SA, Gianolini S, Webb S, Khoo VS; MRC RT01 Trial Management Group; Dearnaley DP. Evaluating the relationship between erectile dysfunction and dose received by the penile bulb: using data from a randomised controlled trial of conformal radiotherapy in prostate cancer (MRC RT01, ISRCTN47772397). Radiother Oncol. 2006 Sep;80(3):355-62. doi: 10.1016/j.radonc.2006.07.037. Epub 2006 Sep 1.

    PubMed 16949694

  • Dearnaley DP, Hall E, Lawrence D, Huddart RA, Eeles R, Nutting CM, Gadd J, Warrington A, Bidmead M, Horwich A. Phase III pilot study of dose escalation using conformal radiotherapy in prostate cancer: PSA control and side effects. Br J Cancer. 2005 Feb 14;92(3):488-98. doi: 10.1038/sj.bjc.6602301.

    PubMed 15685244

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing gonadotrophin releasing hormone and radiation therapy in people with Prostate Cancer, run by Medical Research Council at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United Kingdom, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003290, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2013.

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