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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392535

Locations
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
Halton Hospital
Cheshire, England, United Kingdom, WA7 2DA
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
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
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom, CH63 4JY
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom, NR4 7UY
Whiston Hospital
Prescot Merseyside, England, United Kingdom, L35 5DR
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, United Kingdom, PR2 9HT
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 Incorporating Belvoir Park Hospital
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
Study Chair: David P. Dearnaley, MD, FRCP, FRCR Royal Marsden NHS Foundation Trust
  More 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
Hormones
Cyproterone
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

ClinicalTrials.gov processed this record on December 05, 2016