Tumor-directed radiation therapy for high-risk localized prostate cancer
Real-time Image-guided Ultra-hypofractionated Focal Boost to Intraprostatic Lesion(s) With Lymph Node Irradiation for a Very High High-risk Localized Prostate Cancer (the HYPO-RT-PC Boost Trial)
This study is testing a new type of targeted radiation therapy for men with very high-risk localized prostate cancer to see if it can effectively treat their cancer while using advanced imaging techniques.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Region Skane Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Lund and 1 other locations) |
| Trial ID | NCT06220435 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with histologically confirmed very high-risk localized prostate cancer and specific imaging findings.
Not a fit: Patients with regional or distant metastasis or those who have had previous pelvic radiotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective localized therapy for patients with very high-risk prostate cancer, potentially improving outcomes.
How similar studies have performed: Other studies have shown promise with similar ultra-hypofractionated radiation approaches, but this specific combination is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lund and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.