An observational study in Radiation Toxicity, sponsored by University of Milano Bicocca. Recruiting at 2 sites in Italy. Open to male participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-10-25.
Sponsored by University of Milano Bicocca · Observational
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.
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 6.2 Gy to the prostatic bed delivered in one week, and up to 32.5 Gy in 5 sessions each of 6.5 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 v5.0. 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.
University of Milano Bicocca is the lead sponsor of 124 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with adverse pathological features or biochemical and clinical relapse following radical prostatectomy
EXCLUSION CRITERIA
Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0
To assess treatment related acute (\< 90 days from the end of treatment) and late (\> 90 days) gastrointestinal (GI) and genitourinary (GU) toxicity in patients who undergo postoperative SBRT using CTCAE v.5.0
Time frame: 60 months
QUALITY OF LIFE (QOL) assessed by Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire. For each domain minimum symptom score (=0) means best QOL and maximum symptom score (=12) means worst QOL
To measure symptom scores for each QOL domain (urinary incontinence, urinary irritative/obstructive, bowel, sexual) after SDRT by EPIC-26 Questionnaire
Time frame: 60 months
Number of participants with urinary incontinence assessed by International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), ranging from 0 (best) to 21 (worst)
To assess urinary continence after postoperative SBRT using ICIQ-SF
Time frame: 60 months
Number of participants with erectile dysfunction assessed by International Index of Erectile Function Questionnaire ranging from 5 (worst ) to 25 (best)
To assess erectile function after postoperative SBRT using IIEF 5
Time frame: 60 months
Number of participants with biochemical relapse assessed by PSA (cut off 0.20 ng/mL)
To assess biochemical outcome after postoperative SBRT using serum PSA levels
Time frame: 60 months
Plan to share: Yes — outcomes of individual participant data sets will be shared with other investigators involved in the study
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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University of Milano Bicocca