NCT06220435Recruiting
Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of 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)
Source: ClinicalTrials.gov · Last updated 12 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- First submitted
- 10 Jan 2024
- Start date
- 25 Sept 2023
- Primary completion date
- 1 Sept 2031
- Lead sponsor
- Region Skane
- Diseases
- Prostate cancer
- NCT number
- NCT06220435
What you commit to
- Study type: Interventional
- Planned participants: 76
- From 25 Sept 2023 to the primary completion date, 1 Sept 2031
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvic radiotherapy
- Prior prostate surgery including transurethral resection of the prostate (TURP)
Other illness
- Other malignancies than prostate cancer and basalioma in the past five years
- Serious disease state that makes study inclusion and treatment unsuitable
Other
- Regional or distant metastasis
- Any contraindications for MRI
- PSA \>150 ng/ml
- Endocrine treatment (past or present)
- Severe lower urinary tract symptoms (International Prostate Symptom Score (IPSS) ≥20)
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Skåne - Skåne University Hospital Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
| Region Västerbotten, Umeå University Hospital Coordinator of this site? Confirm its status | Umeå | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.