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

Prostate Cancer Clinical Trial

Official title:

Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer: CHHIP

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00392535
• Other study ID #: CDR0000510112
• Secondary ID: ICR-CTSU-CHHIP-2
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 18, 2002
• Est. completion date: June 17, 2021

Study information

• Verified date: February 2019
• Source: Institute of Cancer Research, United Kingdom
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3216
• Est. completion date: June 17, 2021
• Est. primary completion date: September 8, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• conventional radiotherapy 74 Gy delivered in 37 fractions

• hypofractionated radiation therapy 60 Gy in 20 fractions

• hypofractionated radiation therapy 57 Gy in 19 fractions

Locations

Country	Name	City	State
United Kingdom	Basingstoke and North Hampshire NHS Foundation Trust	Basingstoke	England
United Kingdom	Belfast City Hospital Trust	Belfast	Northern Ireland
United Kingdom	Sussex Cancer Centre at Royal Sussex County Hospital	Brighton	England
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	West Suffolk Hospital	Bury St. Edmunds	England
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
United Kingdom	Countess of Chester Hospital	Chester	England
United Kingdom	Walsgrave Hospital	Coventry	England
United Kingdom	Eastbourne District General Hospital	Eastbourne	England
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow	Scotland
United Kingdom	St. Luke's Cancer Centre at Royal Surrey County Hospital	Guildford	England
United Kingdom	Ipswich Hospital	Ipswich	England
United Kingdom	Clatterbridge Centre for Oncology	Liverpool	England
United Kingdom	Royal Marsden - London	London	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	Christie Hospital	Manchester	England
United Kingdom	Norfolk and Norwich University Hospital	Norwich	England
United Kingdom	Whiston Hospital	Prescot	England
United Kingdom	Rosemere Cancer Centre at Royal Preston Hospital	Preston	England
United Kingdom	Halton Hospital	Runcorn	England
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield	England
United Kingdom	Southport and Formby District General Hospital	Southport	England
United Kingdom	Royal Marsden - Surrey	Sutton	England
United Kingdom	Warrington Hospital NHS Trust	Warrington	England
United Kingdom	Worthing Hospital	Worthing	England

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

References & 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, So — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disease-free survival		time from randomisation to any prostate cancer-related event or death from any cause up to 15 years
Secondary	Overall survival		Time from randomisation to death from any cause up to 15 years
Secondary	Development of metastases		Time from randomisation to development of metastases up to 15 years
Secondary	Recommencement of hormonal treatment for disease recurrence		Time from randomisation to recommencement of hormone treatment for disease recurrence up to 15 years
Secondary	Acute and late side-effects		Peak and week 18 bowel and bladder side-effects

External Links

•   ISRCTN registry