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Prostate CancerNCT00392535

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

A study testing conventional radiotherapy 74 Gy delivered in 37 fractions, hypofractionated radiation therapy 60 Gy in 20 fractions and hypofractionated radiation therapy 57 Gy in 19 fractions in people with Prostate Cancer, run by Institute of Cancer Research, United Kingdom at 26 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
conventional radiotherapy 74 Gy delivered in 37 fractions, hypofractionated radiation therapy 60 Gy in 20 fractions and hypofractionated radiation therapy 57 Gy in 19 fractions
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,216 participants
Where
26 sitesUnited Kingdom
Study dates
18 Oct 2002to 17 Jun 2021
Phase
Interventional
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 18 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

United Kingdom26 sites

  • Basingstoke and North Hampshire NHS Foundation Trust

    Basingstoke, England, RG24 9NA

  • Belfast City Hospital Trust

    Belfast, Northern Ireland, BT8 8JR

  • Sussex Cancer Centre at Royal Sussex County Hospital

    Brighton, England, BN2 5BF

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

  • West Suffolk Hospital

    Bury St Edmunds, England, IP33 2QZ

  • Addenbrooke's Hospital

    Cambridge, England, CB2 2QQ

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales, CF14 2TL

  • Countess of Chester Hospital

    Chester, England, CH2 1UL

  • Walsgrave Hospital

    Coventry, England, CV2 2DX

  • Eastbourne District General Hospital

    Eastbourne, England, BN21 2UD

  • Beatson West of Scotland Cancer Centre

    Glasgow, Scotland, G12 0YN

  • St. Luke's Cancer Centre at Royal Surrey County Hospital

    Guildford, England, GU2 7XX

  • Ipswich Hospital

    Ipswich, England, IP4 5PD

  • Clatterbridge Centre for Oncology

    Liverpool, England, CH63 4JY

  • Saint Bartholomew's Hospital

    London, England, EC1A 7BE

  • Royal Marsden - London

    London, England, SW3 6JJ

  • Christie Hospital

    Manchester, England, M20 4BX

  • Norfolk and Norwich University Hospital

    Norwich, England, NR4 7UY

  • Whiston Hospital

    Prescot, England, L35 5DR

  • Rosemere Cancer Centre at Royal Preston Hospital

    Preston, England, PR2 9HT

  • Halton Hospital

    Runcorn, England, WA7 2DA

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S10 2SJ

  • Southport and Formby District General Hospital

    Southport, England, PR8 6PN

  • Royal Marsden - Surrey

    Sutton, England, SM2 5PT

  • Warrington Hospital NHS Trust

    Warrington, England, WA5 1QG

  • Worthing Hospital

    Worthing, England, BN11 2DH

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Conditions
Prostate Cancer
Being tested
conventional radiotherapy 74 Gy delivered in 37 fractions, hypofractionated radiation therapy 60 Gy in 20 fractions, hypofractionated radiation therapy 57 Gy in 19 fractions
Keywords
adenocarcinoma of the prostate, 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.

  • conventional radiotherapy 74 Gy delivered in 37 fractionsRadiation

  • hypofractionated radiation therapy 60 Gy in 20 fractionsRadiation

  • hypofractionated radiation therapy 57 Gy in 19 fractionsRadiation

Study groups in NCT00392535
Study groupRoleWhat they receive
Control armActive comparatorconventional radiotherapy (74 Gy delivered in 37 fractions over 7·4 weeks)
Receives: Radiation: conventional radiotherapy 74 Gy delivered in 37 fractions
Hypofractionated arm 1ExperimentalHypofractionated radiotherapy (60 Gy in 20 fractions over 4 weeks)
Receives: Radiation: hypofractionated radiation therapy 60 Gy in 20 fractions
Hypofractionated arm 2ExperimentalHypofractionated radiotherapy (57 Gy in 19 fractions over 3·8 weeks)
Receives: Radiation: hypofractionated radiation therapy 57 Gy in 19 fractions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to biochemical or clinical failure

    Phoenix consensus guidelines as a PSA concentration greater than nadir plus 2 ng/mL.

    Measured: Defined as the time from randomisation to biochemical failure or prostate cancer recurrence up to 5 years

Secondary outcomes (5)

  1. Disease-free survival

    Measured: time from randomisation to any prostate cancer-related event or death from any cause up to 15 years

  2. Overall survival

    Measured: Time from randomisation to death from any cause up to 15 years

  3. Development of metastases

    Measured: Time from randomisation to development of metastases up to 15 years

  4. Recommencement of hormonal treatment for disease recurrence

    Measured: Time from randomisation to recommencement of hormone treatment for disease recurrence up to 15 years

  5. Acute and late side-effects

    Measured: Peak and week 18 bowel and bladder side-effects

Timeline

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

  1. First posted26 Oct 2006 (estimated)
  2. Study start18 Oct 2002
  3. Primary completion8 Sep 2015
  4. Study completion17 Jun 2021 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Enrolment
3,216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00392535
Sponsor's protocol ID
CDR0000510112
Other IDs
ICR-CTSU-CHHIP-2006-10007, ISRCTN97182923, EU-20646
Status last verified
Feb 2019
First submitted
25 Oct 2006
Last updated
27 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E; CHHiP Investigators. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016 Aug;17(8):1047-1060. doi: 10.1016/S1470-2045(16)30102-4. Epub 2016 Jun 20.

    PubMed 27339115

Questions about this trial

What is this clinical trial studying?

A study testing conventional radiotherapy 74 Gy delivered in 37 fractions, hypofractionated radiation therapy 60 Gy in 20 fractions and hypofractionated radiation therapy 57 Gy in 19 fractions in people with Prostate Cancer, run by Institute of Cancer Research, United Kingdom at 26 sites in United Kingdom.

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

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United Kingdom. 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.

Are results available for this study?

Results are not available in the source record.

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.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00392535, which also lists 1 linked publication.

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 27 Feb 2019.

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Clinical Trial NCT00392535 | AzTrials