Trials / Recruiting
RecruitingNCT06220435
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)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- Sponsor
- Region Skane · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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. 76 participants will be enrolled in the study. 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
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | 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 |
Timeline
- Start date
- 2023-09-25
- Primary completion
- 2031-09-01
- Completion
- 2031-09-01
- First posted
- 2024-01-24
- Last updated
- 2025-08-12
Locations
2 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT06220435. Inclusion in this directory is not an endorsement.