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

NCT00392535 | Unknown DMC

• 4 other identifiers: CDR0000510112ICR-CTSU-CHHIP-2006-10007ISRCTN97182923EU-20646
• Study Type: interventional
• Target: 3,216
• Locations: 1 country
• Sites: 26

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (1)

• Time to biochemical or clinical failure

  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 Outcomes (5)

• Disease-free survival

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

• Overall survival

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

• Development of metastases

  Time from randomisation to development of metastases up to 15 years

• Recommencement of hormonal treatment for disease recurrence

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

• Acute and late side-effects

  Peak and week 18 bowel and bladder side-effects

Study Arms (3)

Control arm

ACTIVE COMPARATOR

conventional radiotherapy (74 Gy delivered in 37 fractions over 7·4 weeks)

Radiation: conventional radiotherapy 74 Gy delivered in 37 fractions

Hypofractionated arm 1

EXPERIMENTAL

Hypofractionated radiotherapy (60 Gy in 20 fractions over 4 weeks)

Radiation: hypofractionated radiation therapy 60 Gy in 20 fractions

Hypofractionated arm 2

EXPERIMENTAL

Hypofractionated radiotherapy (57 Gy in 19 fractions over 3·8 weeks)

Radiation: hypofractionated radiation therapy 57 Gy in 19 fractions

Interventions

conventional radiotherapy 74 Gy delivered in 37 fractions RADIATION

Control arm

hypofractionated radiation therapy 60 Gy in 20 fractions RADIATION

Hypofractionated arm 1

hypofractionated radiation therapy 57 Gy in 19 fractions RADIATION

Hypofractionated arm 2

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead

Study Sites (26)

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, England, RG24 9NA, United Kingdom

Location

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, BN2 5BF, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

West Suffolk Hospital

Bury St Edmunds, England, IP33 2QZ, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Countess of Chester Hospital

Chester, England, CH2 1UL, United Kingdom

Location

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

Eastbourne District General Hospital

Eastbourne, England, BN21 2UD, United Kingdom

Location

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

Guildford, England, GU2 7XX, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

Clatterbridge Centre for Oncology

Liverpool, England, CH63 4JY, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, England, NR4 7UY, United Kingdom

Location

Whiston Hospital

Prescot, England, L35 5DR, United Kingdom

Location

Rosemere Cancer Centre at Royal Preston Hospital

Preston, England, PR2 9HT, United Kingdom

Location

Halton Hospital

Runcorn, England, WA7 2DA, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S10 2SJ, United Kingdom

Location

Southport and Formby District General Hospital

Southport, England, PR8 6PN, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Warrington Hospital NHS Trust

Warrington, England, WA5 1QG, United Kingdom

Location

Worthing Hospital

Worthing, England, BN11 2DH, United Kingdom

Location

Belfast City Hospital Trust

Belfast, Northern Ireland, BT8 8JR, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27339115 RESULT

Related Links

• ISRCTN registry

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• David P. Dearnaley, FRCR

  Royal Marsden NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2006
• First Posted: October 26, 2006
• Study Start: October 18, 2002
• Primary Completion: September 8, 2015
• Study Completion: June 17, 2021
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

GB (26)