Ireland
--:--IST
Recruiting Not applicable

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

NCT06220435 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2023-09-25
Last updated
2025-08-12

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Ultra-hypofractionated radiotherapy regimen.

Ultra-hypofractionated radiotherapy regimen.: * Prostate tumor(s): 49 Gray (Gy)/7 fractions * Prostate gland: 42.7 Gy/7 fractions * Elective lymph nodes: 29.4 Gy/7 fractions * Seminal vesicles: 31.15 Gy/7 fractions

Study 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

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Grade 3+ Genitourinary Adverse Events — start of treatment - 5 years
    Acute grade 3+ genitourinary Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Trial sites (2)

FacilityCityRegionStatus
Region Skåne, Skåne University Hospital Lund Sweden Recruiting
Region Västerbotten, Umeå University Hospital Umeå Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06220435 on ClinicalTrials.gov ↗ ← All trials in Sweden