POst-Prostatectomy Ablative Radiation Therapy
ConditionRadiation Toxicity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-90
SponsorUniversity of Milano Bicocca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adenocarcinoma of the prostate treated with radical prostatectomy (any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy).
Pathologic T3N0/Nx disease or pathologic T2N0/Nx disease, with or without a positive prostatectomy surgical margin
Post-radical prostatectomy PSA of ≥ 0.1 - < 2.0 ng/mL.
Clinical local relapse assessed by Magnetic Resonance Imaging (MRI) of the pelvis
Disqualifiers
N1 and or M1 patients
Prior radiation of any kind to the prostate gland or pelvis
Prior brachytherapy is not allowed
History of inflammatory colitis or other active severe comorbidities
Trial population
Patients with adverse pathological features or biochemical and clinical relapse following radical prostatectomy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov