Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06220435

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

Age: 18Years +
MALE

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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