Clinical trial · Interventional
Hypofractionated Boost vs Conventionally Fractionated Boost for Localized High Risk Prostate Cancer
Randomized Trial of Concomitant Hypofractionated IMRT Boost Versus Conventional Fractionated IMRT Boost for Localized High Risk Prostate Cancer
NCT03526510CI-TRIAL-00056952unknownN/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)
Randomized trial comparing 2 external beam radiotherapy fractionation schemes in patients with localized high risk prostate cancer. Primary endpoint is acute toxicity.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventionally Fractionated versus Hypofractionated Boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Fractionation
- description
- Using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy.
- interventionNames
- Radiation: Conventionally Fractionated versus Hypofractionated Boost
- type
- EXPERIMENTAL
- label
- Hypofractionation
- description
- Using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost).
- interventionNames
- Radiation: Conventionally Fractionated versus Hypofractionated Boost
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent obtained. * Histologically confirmed diagnosis of adenocarcinoma of the prostate. * T1-2 N0 M0, Gleason Score \<= 7, PSA 20 - 100 * T1-2 N0 M0, Gleason Score 8 - 10, PSA \<= 100 * T3 N0 M0, any Gleason Score, PSA \<= 100 Exclusion Criteria: * Patients with unilateral or bilateral hip replacement. * Patients with active collagen vascular disease. * Patients with active inflammatory bowel disease. * Patients with previous radiotherapy to the pelvis. * Patients with ataxia telangiectasia. * Patients with nodal or distant metastases
References
Publications (0)
Data not yet available
No reference posted for this study.