Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06220435
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-01-10
Brief Title:
Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer
Sponsor:
Region Skane
Organization:
Region Skane
Study Overview
Official Title:
Real-time Image-guided Ultra-hypofractionated Focal Boost to Intraprostatic Lesions With Lymph Node Irradiation for a Very High High-risk Localized Prostate Cancer the HYPO-RT-PC Boost Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None