Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer
NCT ID: NCT06220435
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
76 participants
INTERVENTIONAL
2023-09-25
2031-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HYPO-RT-PC boost
Ultra-hypofractionated seven-fraction radiotherapy regimen including focal boost and lymph node irradiation.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
MALE
No
Sponsors
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Region Skane
OTHER
Responsible Party
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Principal Investigators
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Adalsteinn Gunnlaugsson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Region Skåne, Lund University
Locations
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Region Skåne, Skåne University Hospital
Lund, , Sweden
Region Västerbotten, Umeå University Hospital
Umeå, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HYPO-RT-PC boost
Identifier Type: -
Identifier Source: org_study_id
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