Clinical trial · Interventional
Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer
A Randomized Phase III, Multicenter Study to Evaluate Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer
NCT04612907CI-TRIAL-00074470Hypo-M1recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
de Novo metastatic prostate cancer with limited metastatic spread benefits from local radiotherapy to the prostate. Two different fractionation schedules will be tested.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Moderate hypo-fractionation | Radiation | — | UNRESOLVED |
| Ultra-hypo-fractionation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Moderate hypo-fractionation
- description
- Radiotherapy to the prostate delivered in 3Gy fractions x 19
- interventionNames
- Radiation: Moderate hypo-fractionation
- type
- EXPERIMENTAL
- label
- Ultra hypo-fractionation
- description
- Radiotherapy to the prostate delivered in 6.1Gy fractions x 6
- interventionNames
- Radiation: Ultra-hypo-fractionation
Primary outcomes (2)
- measure
- Toxicity as scored by PROM (Patient Reported Outcome Measures) at 8 weeks
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed Informed Consent 2. Histological confirmed prostate cancer 3. Indication for early palliative radiation therapy of low burden metastatic prostate cancer. Low burden as defined by modified CHAARTED trial criteria to maximum 4 skeletal mets at any site and/or any number of lymph nodes 4. baseline E-PROM Exclusion Criteria: 1. High burden metastatic prostate cancer including all with visceral mets. 2. Unable to comply with study procedures. 3. Other diseases or medication that will put the patient at risk for more toxicity from radiotherapy 4. Radiation treatment start later than nine months after the prostate cancer diagnosis. 5. Severe micturition problems, IPSS \> 20 ( International Prostate Symptom Score)
References
Publications (0)
Data not yet available
No reference posted for this study.