Tumor-directed radiation therapy for high-risk localized prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the safety and efficacy of a real-time image-guided ultra-hypofractionated radiation boost combined with lymph node irradiation for patients with node-negative very high-risk localized prostate cancer. It aims to assess the feasibility of this treatment approach and its effectiveness in targeting high-risk lesions. The study will enroll 76 participants and will utilize advanced imaging methods to define focal boosts during concomitant androgen deprivation therapy.

Why it matters

Who can join: the full rules

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)

Where it's running

• Region Skåne, Skåne University Hospital
  Lund, Sweden Recruiting
• Region Västerbotten, Umeå University Hospital
  Umeå, Sweden Recruiting

Study contacts

• Principal investigator: Adalsteinn Gunnlaugsson, MD, PhD — Region Skåne, Lund University
• Study coordinator: Adalsteinn Gunnlaugsson, MD, PhD
• Email: Adalsteinn.Gunnlaugsson@skane.se
• Phone: +46 4617 6268

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.