Radiation Therapy in Treating Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003290
• Other study ID #: CDR0000066222
• Secondary ID: MRC-RT01EU-98005
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: December 3, 2013
• Start date: January 1998
• Est. completion date: August 2004

Study information

• Verified date: July 2001
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• gonadotrophin releasing hormone

Radiation:
• radiation therapy

Locations

Country	Name	City	State
South Africa	Groote Schuur Hospital, Cape Town	Cape Town
United Kingdom	University of Birmingham	Birmingham	England
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Bristol Royal Hospital for Children	Bristol	England
United Kingdom	Derbyshire Royal Infirmary	Derby	England
United Kingdom	Royal Hospital for Sick Children	Edinburgh	Scotland
United Kingdom	Beatson Oncology Centre	Glasgow	Scotland
United Kingdom	Cookridge Hospital	Leeds	England
United Kingdom	University Hospitals of Leicester	Leicester	England
United Kingdom	Middlesex Hospital- Meyerstein Institute	London	England
United Kingdom	Christie Hospital N.H.S. Trust	Manchester	England
United Kingdom	Clatterbridge Centre for Oncology NHS Trust	Merseyside	England
United Kingdom	Newcastle General Hospital	Newcastle Upon Tyne	England
United Kingdom	Mount Vernon Hospital	Northwood	England
United Kingdom	Norfolk & Norwich Hospital	Norwich	England
United Kingdom	Oxford Radcliffe Hospital	Oxford	England
United Kingdom	Royal Preston Hospital	Preston
United Kingdom	Royal Marsden Hospital	Sutton	England
United Kingdom	Southend NHS Trust Hospital	Westcliff-On-Sea	England

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Council

Countries where clinical trial is conducted

South Africa,  United Kingdom, 

References & Publications (16)

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). 2 — View Citation

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 — View Citation

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 conforma — View Citation

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 suppre — View Citation

Gulliford SL, Foo K, Morgan RC, Aird EG, Bidmead AM, Critchley H, Evans PM, Gianolini S, Mayles WP, Moore AR, Sánchez-Nieto B, Partridge M, Sydes MR, Webb S, Dearnaley DP. Dose-volume constraints to reduce rectal side effects from prostate radiotherapy: e — View Citation

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. 201 — View Citation

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 c — View Citation

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. — View Citation

Seddon B, Bidmead M, Wilson J, Khoo V, Dearnaley D. Target volume definition in conformal radiotherapy for prostate cancer: quality assurance in the MRC RT-01 trial. Radiother Oncol. 2000 Jul;56(1):73-83. — View Citation

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. Epub 2007 Dec 3. — View Citation

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 — View Citation

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 tria

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 Soci

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. — View Citation

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 — View Citation

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.

* Note: There are 16 references in all — Click here to view all references