Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582446
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Artificial Intelligence to Personalize Prostate Cancer Treatment the HypoElect Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Whole-pelvis Hypofractionated Radiotherapy Combined With Dose-escalation to the Prostate and Androgen Deprivation Therapy in Primary Localized NCCN and MMAI High-risk Prostate Cancer - a Prospective Single-arm Phase II Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HypoElect
Brief Summary:
A prospective single-arm phase II study is the individualization of RT for patients with high-risk localized PCa based on multimodal artificial intelligence MMAI All patients will receive the current standard of care i a dose escalation to the prostate via HDR brachytherapy ii two years of ADT and iii whole-pelvis UHF-RT 5 fractions
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 For primary high-risk localized PCa patients NCCNv42023 guidelines recommend normo- or hypofractionated RT to the prostate the elective pelvic lymphatics and systemic treatment in terms of ADT Although the standard of care the benefit of this therapy regimen is controversially discussed the benefit of i an RT dose escalation using brachytherapy 2 or focal dose escalated RT3 or ii an elective RT of the pelvic lymph nodes 1 is not finally proven yet In parallel first studies proposed a reduction in treatment fractions in terms of ultra-hypofractionated RT UHF-RT 4
The aim of this prospective single-arm phase II study is the individualization of RT for patients with high-risk localized PCa based on MMAI All patients will receive the current standard of care i a dose escalation to the prostate via HDR brachytherapy ii two years of ADT and iii whole-pelvis UHF-RT 5 fractions
For the HypoElect patients we expect no significant differences in toxicity rates compared to the randomized controlled POP-RT trial 1 which treated the patients with moderately-hypofractionated RT to the prostate and the elective pelvic lymph nodes in parallel to 24 months of ADT Secondary endpoints like relapse free survival metastatic free survival prostate cancer survival and overall survival will depict the oncologic efficacy in this patient cohort Thus the safety and oncologic outcome results of this study might be the first in this highly selected treatment group NCCN high-risk PSMA PET cN0cM0 and MMAI high-risk 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 biomarkers to predict the treatment outcome
The aim of this prospective single-arm phase II study is the individualization of RT for patients with high-risk localized PCa based on MMAI All patients will receive the current standard of care i a dose escalation to the prostate via HDR brachytherapy ii two years of ADT and iii whole-pelvis UHF-RT 5 fractions
For the HypoElect patients we expect no significant differences in toxicity rates compared to the randomized controlled POP-RT trial 1 which treated the patients with moderately-hypofractionated RT to the prostate and the elective pelvic lymph nodes in parallel to 24 months of ADT Secondary endpoints like relapse free survival metastatic free survival prostate cancer survival and overall survival will depict the oncologic efficacy in this patient cohort Thus the safety and oncologic outcome results of this study might be the first in this highly selected treatment group NCCN high-risk PSMA PET cN0cM0 and MMAI high-risk 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 biomarkers to predict the treatment outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None