NCT00392535 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: NA
Status at capture: UNKNOWN
Registry last update: 2019-02-27

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility 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
healthy Volunteers: false
maximum Age: 120 Years
minimum Age: 18 Years
sex: MALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
conventional radiotherapy (74 Gy delivered in 37 fractions over 7·4 weeks)
intervention Names
Radiation: conventional radiotherapy 74 Gy delivered in 37 fractions
label
Control arm
type
ACTIVE_COMPARATOR
description
Hypofractionated radiotherapy (60 Gy in 20 fractions over 4 weeks)
intervention Names
Radiation: hypofractionated radiation therapy 60 Gy in 20 fractions
label
Hypofractionated arm 1
type
EXPERIMENTAL
description
Hypofractionated radiotherapy (57 Gy in 19 fractions over 3·8 weeks)
intervention Names
Radiation: hypofractionated radiation therapy 57 Gy in 19 fractions
label
Hypofractionated arm 2
type
EXPERIMENTAL

interventions

arm Group Labels
Control arm
name
conventional radiotherapy 74 Gy delivered in 37 fractions
type
RADIATION
arm Group Labels
Hypofractionated arm 1
name
hypofractionated radiation therapy 60 Gy in 20 fractions
type
RADIATION
arm Group Labels
Hypofractionated arm 2
name
hypofractionated radiation therapy 57 Gy in 19 fractions
type
RADIATION

Study design

allocation: RANDOMIZED
intervention Model: PARALLEL
primary Purpose: TREATMENT

Enrollment

count: 3216
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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

secondary Outcomes

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

Full study description

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.
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.

Source references

references

citation
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
type
RESULT