Overview
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.
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. 76 participants will be enrolled in the study.
Specific aims of the study are:
- To study the feasibility of ultra-hypofractionation target lesion boost for node-negative very high-risk prostate cancer together with lymph node irradiation (primary outcome).
- To study the effectiveness of ultra-hypofractionated target lesion boost for high-risk prostate cancer.
- To study the feasibility of defining focal boost during concomitant androgen deprivation therapy with advanced functional imaging methods.
Eligibility
Inclusion Criteria:
- Life expectancy >5 years
- Age ≥18 years
- 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 / PSA 20-49 μg/L or and/or Gleason score 9-10 and/or PSA ≥40 μg/L
- At least one PI-RADS 4-5 lesion on diagnostic 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)