Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06330909
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2023-05-23
Brief Title:
Image-guided Focal Dose Escalation- Primary pc Treated With Primary External Beam HypofractStereotactic rt
Sponsor:
University Hospital Freiburg
Organization:
University Hospital Freiburg
Study Overview
Official Title:
Image-guided Focal Dose Escalation in Patients With Primary Prostate Cancer Treated With Primary External Beam Hypofractionated Stereotactic Radiation Therapy HypoFocal-SBRT - a Prospective Multicenter Randomized Phase III Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
HypoF-SBRT
Brief Summary:
Technical advances in radiotherapy RT treatment planning and delivery have substantially changed RT concepts for primary prostate cancer PCa by i enabling a reduction of treatment time and by ii enabling a safe delivery of high RT doses Several studies proposed a dose-response relationship for patients with primary prostate cancer PCa and especially in patients with high-risk features a dose escalation should lead to improved tumor control In parallel to the improvements in RT techniques diagnostic imaging techniques like multiparametric magnetic resonance imaging mpMRI and positron-emission tomography PET evolved and enable an accurate depiction of the intraprostatic tumor mass for the first time The HypoFocal-SBRT study combines ultra-hypofractionated RT stereotactic body RT reduction of treatment time with a focal RT dose escalation on intraprostatic tumor sides by applying state of the art diagnostic imaging and most modern RT concepts This novel concept will be compared with moderate hypofractionated RT MHRT one option for the curative primary treatment of PCa which has been proven by several prospective trials and is recommended and carried out worldwide We suspect an increase in relapse-free survival RFS and we will also assess quality of life in order to detect potential changes
Detailed Description:
Prostate cancer PCa is the most frequent diagnosed malignancy in male patients in Europe and radiation therapy RT is a main treatment option Conventional RT for patients with primary PCa aims at delivering a homogeneous dose to the entire prostatic gland However recent studies proved that modern medical imaging is able to detect accurately the intraprostatic tumour mass ITM Consequently RT concepts for PCa have an imminent need to be rectified in order to individualize the RT strategy by considering the individual tumor localization In addition the radiobiological characteristics of the major organs at risk the rectum and urinary bladder urethra as well as of the PCa itself speak for clear advantages of hypofractionated radiation therapy High-precision stereotactic body radiation therapy SBRT significantly shortens the duration of treatment with clear implications for quality of life and socio-economic aspects
The aim of this prospective randomized multicenter phase III study is the personalization of RT for patients with primary PCa based on individual tumor geometry derived from modern imaging techniques mpMRI and PSMA-PETCT In the experimental arm A simultaneous RT dose escalation to the ITM will be performed under strict adherence to the organs at risks dose constraints by using SBRT ultra-hypofractionated radiation therapy in a shorter treatment time 5 fractions vs 20 fractions In the control arm arm B the entire prostatic gland will receive a homogeneous moderately hypofractionated RT according to the current guidelines RFS after RT calculated from randomization will be assessed as the primary endpoint as well as toxicities and patient reported quality of life as secondary endpoints For the patients in the experimental arm we expect a significant benefit in relapse free survival from 80 to 90 at 5 years The improvement in relapse free survival could increase the metastatic free survival prostate cancer survival and overall survival in high risk PCa patients Considering the epidemiological importance of the PCa these results could have a significant socio-economic impact In parallel a translational research program will address the identification of novel biomarkersbio-imaging-markers predictive for outcome after RT Furthermore involvement of patient representatives includes information about the studies status and contributes to patient empowerment These aspects will facilitate the evolution from an individualized RT to a personalized RT
The aim of this prospective randomized multicenter phase III study is the personalization of RT for patients with primary PCa based on individual tumor geometry derived from modern imaging techniques mpMRI and PSMA-PETCT In the experimental arm A simultaneous RT dose escalation to the ITM will be performed under strict adherence to the organs at risks dose constraints by using SBRT ultra-hypofractionated radiation therapy in a shorter treatment time 5 fractions vs 20 fractions In the control arm arm B the entire prostatic gland will receive a homogeneous moderately hypofractionated RT according to the current guidelines RFS after RT calculated from randomization will be assessed as the primary endpoint as well as toxicities and patient reported quality of life as secondary endpoints For the patients in the experimental arm we expect a significant benefit in relapse free survival from 80 to 90 at 5 years The improvement in relapse free survival could increase the metastatic free survival prostate cancer survival and overall survival in high risk PCa patients Considering the epidemiological importance of the PCa these results could have a significant socio-economic impact In parallel a translational research program will address the identification of novel biomarkersbio-imaging-markers predictive for outcome after RT Furthermore involvement of patient representatives includes information about the studies status and contributes to patient empowerment These aspects will facilitate the evolution from an individualized RT to a personalized RT
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DRKS00022915 | OTHER | Deutsches Register Klinische Studien | None |