Status:
RECRUITING
Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer
Lead Sponsor:
Region Skane
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 irradiat...
Detailed 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 irradiat...
Eligibility Criteria
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
- 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)
Key Trial Info
Start Date :
September 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2031
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06220435
Start Date
September 25 2023
End Date
September 1 2031
Last Update
August 12 2025
Active Locations (2)
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1
Region Skåne, Skåne University Hospital
Lund, Sweden
2
Region Västerbotten, Umeå University Hospital
Umeå, Sweden