Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04831970
Status:
RECRUITING
Last Update Posted:
2022-10-25
First Post:
2021-03-30
Brief Title:
POst-Prostatectomy Ablative Radiation Therapy
Sponsor:
University of Milano Bicocca
Organization:
University of Milano Bicocca
Study Overview
Official Title:
POst-Prostatectomy Ablative Radiation Therapy
Status:
RECRUITING
Status Verified Date:
2022-10
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:
POPART
Brief Summary:
The use of hypofractionated radiotherapy for prostate cancer has matured to a point that in current guidelines extremely hypofractionated image-guided IMRT regimens 6 Gy per fraction or greater can be considered an alternative to conventionally fractionated regimens at clinics with appropriate technology physics and clinical expertise The delivery of fewer and larger fractions with hypofractionation compared to conventional radiotherapy might effectively improve the therapeutic ratio while maintaining isoeffective tumour doses thus shortening overall treatment time In the present study patients will undergo postoperative image-guided SBRT by means of volumetric intensity-modulated arc radiotherapy IGRT-VMAT with state-of-the-art treatment-planning and quality assurance procedures Normal tissue sparing and delivery accuracy are accomplished by the use of devices that ensure stability and beam location reproducibility The primary endpoint is to evaluate the cumulative incidence of treatment related toxicities and adverse events in the acute 90 days from the end of treatment and late 90 days setting
Detailed Description:
In this observational prospective trial eligible patients are those with adverse pathological features or rising PSA after radical prostatectomy proposed for receiving 31 Gy in 5 sessions each of 62 Gy to the prostatic bed delivered in one week and up to 325 Gy in 5 sessions each of 65 Gy delivered in one week respectively in case of clinical relapse
Patients will be treated by means of image guided volumetric modulated radiotherapy IGRT-VMAT A real time non-ionizing target monitoring might be used to account for intra-fractional errors if deemed appropriate Whether the dose constraints to the normal tissues are at risk these will be prioritised over the prescription dose to the target The primary endpoint of the trial is to assess 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 approximately 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 ICIQ-SF at various timepoints Percentage or total mean score will be reported according to 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 treated by means of image guided volumetric modulated radiotherapy IGRT-VMAT A real time non-ionizing target monitoring might be used to account for intra-fractional errors if deemed appropriate Whether the dose constraints to the normal tissues are at risk these will be prioritised over the prescription dose to the target The primary endpoint of the trial is to assess 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 approximately 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 ICIQ-SF at various timepoints Percentage or total mean score will be reported according to 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