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

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ClinicalTrials.gov Identifier: NCT00392535
Recruitment Status : Active, not recruiting
First Posted : October 26, 2006
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom

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 Radiation: conventional radiotherapy 74 Gy delivered in 37 fractions Radiation: hypofractionated radiation therapy 60 Gy in 20 fractions Radiation: hypofractionated radiation therapy 57 Gy in 19 fractions Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer: CHHIP
Actual Study Start Date : October 18, 2002
Actual Primary Completion Date : September 8, 2015
Estimated Study Completion Date : June 17, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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



Primary Outcome Measures :
  1. 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.


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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00392535


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

Additional Information:
Publications of Results:
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Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT00392535     History of Changes
Other Study ID Numbers: CDR0000510112
ICR-CTSU-CHHIP-2006-10007
ISRCTN97182923
EU-20646
First Posted: October 26, 2006    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institute of Cancer Research, United Kingdom:
adenocarcinoma of the prostate
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
Genital Diseases, Male
Prostatic Diseases