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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00392535
First received: October 25, 2006
Last updated: May 19, 2011
Last verified: July 2009
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: cyproterone acetate
Drug: releasing hormone agonist therapy
Radiation: hypofractionated radiation therapy
Radiation: intensity-modulated radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer: CHHIP

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Acute and late radiation-induced side effects [ Designated as safety issue: Yes ]
  • Freedom from prostate cancer recurrence [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute and late radiation-induced side effects [ Designated as safety issue: Yes ]
  • Development of metastases [ Designated as safety issue: No ]
  • Recommencement of hormonal treatment for disease occurrence [ Designated as safety issue: No ]
  • Cause-specific and overall survival [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Health economics [ Designated as safety issue: No ]
  • Models of normal tissue and tumor control [ Designated as safety issue: No ]

Estimated Enrollment: 2163
Study Start Date: October 2002
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00392535

Locations
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    fiona.mckinna@bsuh.nhs.uk   
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    julian.money-kyrle@royalsurrey.nhs.uk   
Ipswich Hospital Recruiting
Ipswich, England, United Kingdom, IP4 5PD
Contact: Christopher Scrase, MD    44-147-370-4177      
Royal Marsden - London Recruiting
London, England, United Kingdom, SW3 6JJ
Contact: Contact Person    44-20-7352-8171      
Saint Bartholomew's Hospital Recruiting
London, England, United Kingdom, EC1A 7BE
Contact: Paula Wells, MD    44-207-601-8044      
Christie Hospital Recruiting
Manchester, England, United Kingdom, M20 4BX
Contact: John Logue    44-161-446-3407    john.logue@christie-tr.nwest.nhs.uk   
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    alison.birtle@lthtr.nhs.uk   
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
Investigators
Study Chair: David P. Dearnaley, MD, FRCP, FRCR Royal Marsden NHS Foundation Trust
  More Information

Additional Information:
Publications:
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.

ClinicalTrials.gov Identifier: NCT00392535     History of Changes
Other Study ID Numbers: CDR0000510112, ICR-CTSU-CHHIP-2006-10007, ISRCTN97182923, EU-20646
Study First Received: October 25, 2006
Last Updated: May 19, 2011
Health Authority: Unspecified

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
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Cyproterone
Cyproterone Acetate
Diane
Hormones
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on April 22, 2014