Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer

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 irradiation for patients with node-negative high risk localized prostate cancer.

Eligibility

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)

Conditions2

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