Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04831983
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2021-03-30
Brief Title:
ABlative Radiotherapy for Unfavorable Prostate Tumors
Sponsor:
University of Milano Bicocca
Organization:
University of Milano Bicocca
Study Overview
Official Title:
Single-Dose Image-Guided Radiotherapy IGRT With Focal Boost to the MRI-defined Macroscopic Tumor Volume for Intermediate Unfavorable and High Risk Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-01
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:
ABRUPT
Brief Summary:
Published clinical evidence confirms that a single dose of 24 Gy provides unprecedented long-term local control in primary and metastatic prostate cancer with safe toxicity profiles provided that exposure of surrounding healthy tissues is critically assessed with fulfillment of strict constraints and dose distribution is accomplished using image guidance and tracking tools In the present trial intermediate unfavorable and selected high-risk organ-confined prostate cancer patients will undergo Single Dose Radiation Therapy SDRT With Focal Boost to the MRI-defined Macroscopic Tumor Volume by means of image-guided volumetric intensity-modulated arc radiotherapy IGRT-VMAT and state-of-the-art treatment-planning and quality assurance procedures Androgen Deprivation Therapy ADT type and duration has been set as per standard of care in accordance with current recommendations and guidelines
Detailed Description:
Patients enrolled in this observational prospective trial will be offered image-guided volumetric modulated radiotherapy IGRT-VMAT in a single session SDRT of 21 Gy to the whole gland with a simultaneous boost of 24 Gy to the macroscopic PI-RADS driven 4-5 tumours ADT will be prescribed concomitantly as per standard of care A real time non-ionizing prostate monitoring will be used to account for intra-fractional errors If the dose constraints to the normal tissues are at risk these will be prioritised over the aimed boost dose The primary endpoint of the trial is the treatment related toxicity measured by the CTCAE v50 Secondary endpoints are quality of life in different domains sexual rectal urinary and biochemical outcome
Patients will be followed at one month then every 3 months for the first 12 months and every 6 months thereafter Quality of Life will be prospectively evaluated through validated tools ECOG EPIC IIEF-5 IPSS ICIQ-SF at various timepoints Percentage or total mean score will be reported according the questionnaires whether they grade values in a scale or use descriptive statistics Kaplan-Meier curve analysis of biochemical relapse free survival b-RFS at 2 and 5-year bRFS for all patients will be estimated
Patients will be followed at one month then every 3 months for the first 12 months and every 6 months thereafter Quality of Life will be prospectively evaluated through validated tools ECOG EPIC IIEF-5 IPSS ICIQ-SF at various timepoints Percentage or total mean score will be reported according the questionnaires whether they grade values in a scale or use descriptive statistics Kaplan-Meier curve analysis of biochemical relapse free survival b-RFS at 2 and 5-year bRFS for all patients will be estimated
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