Clinical trial · Interventional
Hypofractionated Radiotherapy in Prostate Cancer Patients Aged 75 Years or Older.
Clinical Study to Evaluate Hypofractionated Radiotherapy in Prostate Cancer Patients Aged 75 Years or Older.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Treatment standard has changed.
Summary
Brief summary (as posted)
The majority of all new prostate cancer cases are diagnosed in men aged \> 70 years, with the highest incidence in men aged \> 90 years. Management options for localized prostate cancer include active surveillance in patients with low-risk disease, radical prostatectomy or external beam radiation therapy. In previous studies, hypofractionated prostate cancer irradiation regimens have been shown to represent a highly effective treatment option for prostate cancer. However, patients aged 75 years or older were underrepresented in most trials resulting in the lack of a robust evidence base. The proposed study will evaluate radiation-induced toxicity as well as outcome after hypofractionated external beam radiotherapy in prostate cancer patients aged 75 years or older.
Conditions
Conditions (2)
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 |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionated radiotherapy
- interventionNames
- Radiation: Hypofractionated radiotherapy
Primary outcomes (2)
- measure
- Acute radiation - induced toxicity
- timeFrame
- Measurement at the last 1 day of radiotherapy
- description
- Toxicity score using Common Terminology for Adverse Events (CTCAE)
- measure
- Acute radiation - induced toxicity
- timeFrame
- Measurement 3 months after completion of radiotherapy
- description
- Toxicity score using Common Terminology for Adverse Events (CTCAE)
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed prostate cancer adenocarcinoma * definitive radiotherapy for curative intent * low or intermediate risk prostate cancer * patient age ≥ 75 years * given informed consent Exclusion Criteria: * chronic inflammatory bowel disease * high risk prostate cancer * lymph node or distant metastases * unable to give informed consent
References
Publications (1)
- BACKGROUNDDearnaley 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