Clinical trial · Interventional
Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer
Real-time Image-guided Ultra-hypofractionated Focal Boost to Intraprostatic Lesion(s) With Lymph Node Irradiation for a Very High High-risk Localized Prostate Cancer (the HYPO-RT-PC Boost Trial)
NCT06220435CI-TRIAL-00093519recruitingN/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)
HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultra-hypofractionated radiotherapy regimen. | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HYPO-RT-PC boost
- description
- Ultra-hypofractionated seven-fraction radiotherapy regimen including focal boost and lymph node irradiation.
- interventionNames
- Radiation: Ultra-hypofractionated radiotherapy regimen.
Primary outcomes (1)
- measure
- Grade 3+ Genitourinary Adverse Events
- timeFrame
- start of treatment - 5 years
- description
- Acute grade 3+ genitourinary Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Secondary outcomes (11)
- measure
- Grade 2+ Genitourinary Adverse Events
- timeFrame
- start of treatment - 5 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Life expectancy \>5 years * Age ≥18 years * World Health Organization (WHO) performance status 0-2 * Histological evidence of prostate cancer * Classified as very high-risk according to national guidelines (2-3 of following high risk criteria: T3 / Gleason grade 8 /Prostate-specific antigen (PSA) 20-49 μg/L or and/or Gleason score 9-10 and/or PSA ≥40 μg/L * At least one Prostate Imaging-Reporting and Data System (PI-RADS) 4-5 lesion on diagnostic Magnetic resonance imaging (MRI) * Patients must be able to comply with the protocol * Signed informed consent * Adequate laboratory findings: haemoglobin (Hb) \>90 g/L, absolute neutrophil count \>1.0x10\^9/l, platelets \>75x10\^9/l, bilirubin \<2.0 x upper limit of normal (ULN), alanine aminotransferase (ALAT) \<5x ULN and creatinine \<2.0x ULN) Exclusion Criteria: * Regional or distant metastasis * Any contraindications for MRI * PSA \>150 ng/ml * Previous pelvic radiotherapy * Prior prostate surgery including transurethral resection of the prostate (TURP) * Endocrine treatment (past or present) * Other malignancies than prostate cancer and basalioma in the past five years * Serious disease state that makes study inclusion and treatment unsuitable * Severe lower urinary tract symptoms (International Prostate Symptom Score (IPSS) ≥20)
References
Publications (0)
Data not yet available
No reference posted for this study.