Targeted high-dose radiation for the highest-risk localized prostate cancer
Tests a short, targeted radiation course in adults with high-risk localized prostate cancer.
Plain-language title generated from the registry record
Registry title: Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer
Key facts
- Where
- Lund and Umeå, SwedenSee the 2 sites
Where in Sweden
- Region Skåne - Skåne University HospitalLund, SwedenTaking people
- Region Västerbotten, Umeå University HospitalUmeå, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Skane
- Trial code
- NCT06220435
- Record updated
- 12 August 2025
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: Previous pelvic radiotherapy; Prior prostate surgery including transurethral resection of the prostate (TURP); Other malignancies than prostate cancer and basalioma in the past five years; Serious disease state that makes study inclusion and treatment unsuitable; Regional or distant metastasis; Any contraindications for MRI; PSA >150 ng/ml; Endocrine treatment (past or present); Severe lower urinary tract symptoms (International Prostate Symptom Score (IPSS) ≥20).