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

February 26, 2019 updated by: Institute of Cancer Research, United Kingdom

Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer: CHHIP

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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

Enrollment (Actual)

3216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Basingstoke, England, United Kingdom, RG24 9NA
        • Basingstoke and North Hampshire NHS Foundation Trust
      • Brighton, England, United Kingdom, BN2 5BF
        • Sussex Cancer Centre at Royal Sussex County Hospital
      • Bristol, England, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology centre
      • Bury St. Edmunds, England, United Kingdom, IP33 2QZ
        • West Suffolk Hospital
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital
      • Chester, England, United Kingdom, CH2 1UL
        • Countess of Chester Hospital
      • Coventry, England, United Kingdom, CV2 2DX
        • Walsgrave Hospital
      • Eastbourne, England, United Kingdom, BN21 2UD
        • Eastbourne District General Hospital
      • Guildford, England, United Kingdom, GU2 7XX
        • St. Luke's Cancer Centre at Royal Surrey County Hospital
      • Ipswich, England, United Kingdom, IP4 5PD
        • Ipswich Hospital
      • Liverpool, England, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology
      • London, England, United Kingdom, EC1A 7BE
        • Saint Bartholomew's Hospital
      • London, England, United Kingdom, SW3 6JJ
        • Royal Marsden - London
      • Manchester, England, United Kingdom, M20 4BX
        • Christie Hospital
      • Norwich, England, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital
      • Prescot, England, United Kingdom, L35 5DR
        • Whiston Hospital
      • Preston, England, United Kingdom, PR2 9HT
        • Rosemere Cancer Centre at Royal Preston Hospital
      • Runcorn, England, United Kingdom, WA7 2DA
        • Halton Hospital
      • Sheffield, England, United Kingdom, S10 2SJ
        • Cancer Research Centre at Weston Park Hospital
      • Southport, England, United Kingdom, PR8 6PN
        • Southport and Formby District General Hospital
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden - Surrey
      • Warrington, England, United Kingdom, WA5 1QG
        • Warrington Hospital NHS Trust
      • Worthing, England, United Kingdom, BN11 2DH
        • Worthing Hospital
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT8 8JR
        • Belfast City Hospital Trust
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 0YN
        • Beatson West of Scotland Cancer Centre
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 2TL
        • Velindre Cancer Center at Velindre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

  • 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)

PRIOR CONCURRENT THERAPY:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control arm
conventional radiotherapy (74 Gy delivered in 37 fractions over 7·4 weeks)
Radiation: conventional radiotherapy 74 Gy delivered in 37 fractions
Experimental: Hypofractionated arm 1
Hypofractionated radiotherapy (60 Gy in 20 fractions over 4 weeks)
Radiation: hypofractionated radiation therapy 60 Gy in 20 fractions
Experimental: Hypofractionated arm 2
Hypofractionated radiotherapy (57 Gy in 19 fractions over 3·8 weeks)
Radiation: hypofractionated radiation therapy 57 Gy in 19 fractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to biochemical or clinical failure
Time Frame: Defined as the time from randomisation to biochemical failure or prostate cancer recurrence up to 5 years
Phoenix consensus guidelines as a PSA concentration greater than nadir plus 2 ng/mL.
Defined as the time from randomisation to biochemical failure or prostate cancer recurrence up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival
Time Frame: time from randomisation to any prostate cancer-related event or death from any cause up to 15 years
time from randomisation to any prostate cancer-related event or death from any cause up to 15 years
Overall survival
Time Frame: Time from randomisation to death from any cause up to 15 years
Time from randomisation to death from any cause up to 15 years
Development of metastases
Time Frame: Time from randomisation to development of metastases up to 15 years
Time from randomisation to development of metastases up to 15 years
Recommencement of hormonal treatment for disease recurrence
Time Frame: Time from randomisation to recommencement of hormone treatment for disease recurrence up to 15 years
Time from randomisation to recommencement of hormone treatment for disease recurrence up to 15 years
Acute and late side-effects
Time Frame: Peak and week 18 bowel and bladder side-effects
Peak and week 18 bowel and bladder side-effects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cancer Research, United Kingdom

Investigators

  • Study Chair: David P. Dearnaley, FRCR, Royal Marsden NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2002

Primary Completion (Actual)

September 8, 2015

Study Completion (Anticipated)

June 17, 2021

Study Registration Dates

First Submitted

October 25, 2006

First Submitted That Met QC Criteria

October 25, 2006

First Posted (Estimate)

October 26, 2006

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000510112
  • ICR-CTSU-CHHIP-2006-10007
  • ISRCTN97182923
  • EU-20646

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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