Actively Recruiting
Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer
Led by Region Skane · Updated on 2025-08-12
76
Participants Needed
2
Research Sites
414 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Life expectancy over 5 years
- Age 18 years or older
- World Health Organization (WHO) performance status 0-2
- Histological confirmation of prostate cancer
- Classified as very high-risk by national guidelines with 2-3 high risk criteria: T3 stage, Gleason grade 8, PSA 20-49 µg/L, Gleason score 9-10, or PSA 40 µg/L or higher
- At least one PI-RADS 4-5 lesion on prostate MRI
- Able to comply with the study protocol
- Signed informed consent
- Adequate laboratory results: hemoglobin over 90 g/L, neutrophil count over 1.0x10^9/L, platelets over 75x10^9/L, bilirubin below 2.0 times the upper limit of normal, alanine aminotransferase below 5 times the upper limit of normal, creatinine below 2.0 times the upper limit of normal
You will not qualify if you...
- Presence of regional or distant metastasis
- Any contraindications to MRI
- PSA level over 150 ng/ml
- Previous pelvic radiotherapy
- Prior prostate surgery including transurethral resection of the prostate (TURP)
- Past or present endocrine treatment
- Other cancers (except basalioma) within the past five years
- Serious medical conditions making participation or treatment unsuitable
- Severe lower urinary tract symptoms with International Prostate Symptom Score of 20 or higher
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Region Skåne, Skåne University Hospital
Lund, Sweden
Actively Recruiting
2
Region Västerbotten, Umeå University Hospital
Umeå, Sweden
Actively Recruiting
Research Team
A
Adalsteinn Gunnlaugsson, MD, PhD
CONTACT
H
HYPO-RT-PC boost Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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