Intensity-Modulated Radiation Therapy in Treating Patients With Localized Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00392535
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : October 26, 2006
Last Update Posted : May 20, 2011
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which schedule of intensity-modulated radiation therapy is more effective in treating patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying the side effects of three schedules of intensity-modulated radiation therapy and compares how well they work in treating patients with localized prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: cyproterone acetate Drug: releasing hormone agonist therapy Radiation: hypofractionated radiation therapy Radiation: intensity-modulated radiation therapy Phase 3

Detailed Description:


  • Determine the safety and efficacy of conventional vs hypofractionated high-dose intensity-modulated radiotherapy in patients with localized prostate cancer.
  • Determine the side effects of these regimens in these patients.
  • Determine whether hypofractionated radiotherapy schedules will improve the therapeutic ratio by either improving tumor control or reducing normal tissue side effects.
  • Compare acute and late treatment-related gastrointestinal and urological toxicity in these patients.
  • Determine different prostate-specific antigen-related endpoints for local failure and distant metastases.
  • Extend the database of patients treated to escalated doses with dose-volume histograms (DVHs) of normal tissues at risk and relate these to common toxicity endpoints.
  • Develop a model to estimate normal tissue complication probability (NTCP) of rectum and bladder for hypofractionated as well as conventional dose-escalated radiotherapy schedules.

OUTLINE: This is a multicenter, randomized, pilot study. Patients are stratified according to risk of seminal vesicle involvement (low-risk vs moderate-risk or high-risk).

  • Hormone therapy: Patients receive androgen-deprivation therapy comprising an injection of luteinizing hormone-releasing hormone (LHRH) agonist once monthly for 3-6 months and oral cyproterone acetate beginning the week before the first LHRH agonist injection and continuing for at least 2 weeks after each LHRH agonist injection. Within one week after the last LHRH agonist injection, patients proceed to radiotherapy.
  • Radiotherapy: Patients are randomized to 1 of 3 treatment arms.

    • Arm I: Patients undergo conventional high-dose intensity-modulated radiotherapy (IMRT) in 37 fractions over 7.5 weeks.
    • Arm II: Patients undergo hypofractionated high-dose IMRT in 20 fractions over 4 weeks.
    • Arm III: Patients undergo hypofractionated high-dose IMRT in 19 fractions over 3.8 weeks.

In all arms, treatment continues in the absence of unacceptable toxicity.

Quality of life is assessed periodically during study treatment.

After completion of study treatment, patients are followed periodically for up to 15 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 2,163 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2163 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer: CHHIP
Study Start Date : October 2002
Estimated Primary Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Primary Outcome Measures :
  1. Acute and late radiation-induced side effects
  2. Freedom from prostate cancer recurrence

Secondary Outcome Measures :
  1. Acute and late radiation-induced side effects
  2. Development of metastases
  3. Recommencement of hormonal treatment for disease occurrence
  4. Cause-specific and overall survival
  5. Quality of life
  6. Health economics
  7. Models of normal tissue and tumor control

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate, meeting the following criteria:

    • Clinical stage T1b-T3a, N0, M0
    • Locally confined disease
    • Previously untreated disease
  • Prostate-specific antigen (PSA) ≤ 30 ng/mL
  • Estimated risk of seminal vesicle involvement < 30%

    • Estimated risk of seminal vesicle involvement is defined as PSA + ([Gleason score - 6] x 10) (i.e., if Gleason score ≤ 6, then PSA must be ≤ 30 ng/mL; if Gleason score = 7, then PSA must be < 20 ng/mL; if Gleason score = 8, then PSA must be < 10 ng/mL; if Gleason score = 9 or 10 patient is ineligible)


  • WHO performance status 0 or 1
  • Life expectancy > 10 years (5 years for patients with poorly differentiated cancers)
  • WBC > 4,000/mm^3
  • Hemoglobin > 11g/dL
  • Platelet count > 100,000/mm^3
  • No other active malignancy within the past 5 years except basal cell carcinoma
  • No hip prosthesis or fixation that would interfere with standard radiation beam configuration
  • No comorbid conditions likely to impact on the advisability of radical radiotherapy (e.g., previous inflammatory bowel disease, previous colorectal surgery, significant bladder instability, or urinary incontinence)


  • No prior pelvic radiotherapy
  • No prior radical prostatectomy
  • No prior androgen-deprivation therapy
  • No concurrent full anticoagulation therapy with warfarin or heparin

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 identifier (NCT number): NCT00392535

United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust Recruiting
Basingstoke, England, United Kingdom, RG24 9NA
Contact: Contact Person    44-125-631-4793      
Sussex Cancer Centre at Royal Sussex County Hospital Recruiting
Brighton, England, United Kingdom, BN2 5BF
Contact: David Bloomfield, MD    44-1273-696-955 ext. 7686      
Bristol Haematology and Oncology Centre Recruiting
Bristol, England, United Kingdom, BS2 8ED
Contact: Contact Person    44-117-928-3074      
West Suffolk Hospital Recruiting
Bury St. Edmunds, England, United Kingdom, IP33 2QZ
Contact: Contact Person    44-1284-713-000      
Addenbrooke's Hospital Recruiting
Cambridge, England, United Kingdom, CB2 2QQ
Contact: Helen Patterson, MD    44-122324-5151 ext. 2523 and 2      
Halton Hospital Recruiting
Cheshire, England, United Kingdom, WA7 2DA
Contact: Contact Person    44-1928-714-567      
Countess of Chester Hospital Recruiting
Chester, England, United Kingdom, CH2 1UL
Contact: Contact Person    44-1244-365-000      
Walsgrave Hospital Recruiting
Coventry, England, United Kingdom, CV2 2DX
Contact: Caroline Humber, MD    44-2476-696-7483      
Eastbourne District General Hospital Recruiting
Eastbourne, England, United Kingdom, BN21 2UD
Contact: Fiona McKinna, MD    44-12-7369-6955 ext. 4600   
St. Luke's Cancer Centre at Royal Surrey County Hospital Recruiting
Guildford, England, United Kingdom, GU2 7XX
Contact: J. F. Money-Kyrle, MA, MBBS, MRCP, FRCR    44-1483-406-800   
Ipswich Hospital Recruiting
Ipswich, England, United Kingdom, IP4 5PD
Contact: Christopher Scrase, MD    44-147-370-4177      
Saint Bartholomew's Hospital Recruiting
London, England, United Kingdom, EC1A 7BE
Contact: Paula Wells, MD    44-207-601-8044      
Royal Marsden - London Recruiting
London, England, United Kingdom, SW3 6JJ
Contact: Contact Person    44-20-7352-8171      
Christie Hospital Recruiting
Manchester, England, United Kingdom, M20 4BX
Contact: John Logue    44-161-446-3407   
Clatterbridge Centre for Oncology Recruiting
Merseyside, England, United Kingdom, CH63 4JY
Contact: Isabel Syndikus, MD    44-151-334-1155 ext. 4748      
Norfolk and Norwich University Hospital Recruiting
Norwich, England, United Kingdom, NR4 7UY
Contact: M. J. Ostrowski    44-603-286-286      
Whiston Hospital Recruiting
Prescot Merseyside, England, United Kingdom, L35 5DR
Contact: Zafar Malik, MD    44-151-426-1600      
Rosemere Cancer Centre at Royal Preston Hospital Recruiting
Preston, England, United Kingdom, PR2 9HT
Contact: Alison Birtle, MD    44-177-252-2916   
Cancer Research Centre at Weston Park Hospital Recruiting
Sheffield, England, United Kingdom, S10 2SJ
Contact: Catherine Ferguson, MD    44-114-226-5077      
Southport and Formby District General Hospital Recruiting
Southport, England, United Kingdom, PR8 6PN
Contact: Chinnamani Eswar, MD    44-1704-547-471      
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: David P. Dearnaley, MD, FRCP, FRCR    44-20-8661-3271      
Warrington Hospital NHS Trust Recruiting
Warrington, England, United Kingdom, WA5 1QG
Contact: Contact Person    44-1925-635-911      
Worthing Hospital Recruiting
Worthing, England, United Kingdom, BN11 2DH
Contact: Contact Person    44-1903-205-111      
Belfast City Hospital Trust Incorporating Belvoir Park Hospital Recruiting
Belfast, Northern Ireland, United Kingdom, BT8 8JR
Contact: Contact Person    44-2890-699-204      
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, Scotland, United Kingdom, G12 0YN
Contact: Contact Person    44-141-211-2318      
Velindre Cancer Center at Velindre Hospital Recruiting
Cardiff, Wales, United Kingdom, CF14 2TL
Contact: John Staffurth, MD    44-292-061-5888 ext. 6353      
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Study Chair: David P. Dearnaley, MD, FRCP, FRCR Royal Marsden NHS Foundation Trust

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. Identifier: NCT00392535     History of Changes
Other Study ID Numbers: CDR0000510112
First Posted: October 26, 2006    Key Record Dates
Last Update Posted: May 20, 2011
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
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
Genital Diseases, Male
Prostatic Diseases
Cyproterone Acetate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents