Clinical trial · Interventional
Intensity-Modulated Radiation Therapy in Treating Patients With Localized Prostate Cancer
Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer: CHHIP
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional radiotherapy 74 Gy delivered in 37 fractions | Radiation | — | UNRESOLVED |
| hypofractionated radiation therapy 57 Gy in 19 fractions | Radiation | — | UNRESOLVED |
| hypofractionated radiation therapy 60 Gy in 20 fractions | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Control arm
- description
- conventional radiotherapy (74 Gy delivered in 37 fractions over 7·4 weeks)
- interventionNames
- Radiation: conventional radiotherapy 74 Gy delivered in 37 fractions
- type
- EXPERIMENTAL
- label
- Hypofractionated arm 1
- description
- Hypofractionated radiotherapy (60 Gy in 20 fractions over 4 weeks)
- interventionNames
- Radiation: hypofractionated radiation therapy 60 Gy in 20 fractions
- type
- EXPERIMENTAL
- label
- Hypofractionated arm 2
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTDearnaley 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