24 Gy in One Fraction Urethral-sparing "HDR Like" SBRT for Prostate Cancer
ConditionLocalized Prostate Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorIRCCS San Raffaele
About this trial
Patients with prostate cancer who are candidates for stereotactic radiotherapy to the prostate and seminal vesicles will undergo staging exams, which will include prostate specific membrane antigen (PSMA) positron emission tomography-computed tomography (PET-CT). If the PET scan is negative and the uroflowmetry is acceptable, the patients will perform the treatment, after fiducial implantation, simulation CT and magnetic resonance (MR), in a single fraction, delivered with a high-dose-rate (HDR)-like urethral sparing technique. In 70 patients, acute and late toxicity, biochemical control, overall survival, cancer specific-survival, and quality of life (through specific questionnaires) will be evaluated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histological diagnosis of prostate adenocarcinoma, International Society of Urological Pathology (ISUP) grade groups 1-5
Patients over 18 years of age
Signed informed consent
Negative lymph nodes confirmed by imaging (PSMA PET/CT and/or pelvic MRI with and without contrast medium) where recommended by guidelines (intermediate and high risk patients, according to National Comprehensive Cancer Network (NCCN) guidelines) in the previous 3 months
Disqualifiers
Serious systemic diseases
Psychic or other disorders that may prevent the patient from signing the informed consent
Previous invasive cancer, except skin cancer (excluding melanoma) unless patient free of disease for at least 3 years (e.g. carcinoma in situ of the oral cavity or bladder)
Lymph node disease (N1)
Trial design
Design model
Single group
Treatments tested in this trial
prostate SBRT
RadiationPatients with prostate cancer will be treated with high-dose SBRT to prostate and seminal vesicles, delivered in one fraction, sparing the urethra and generating a dose distribution similar to HDR brachytherapy
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: 24 Gy in one fraction, urethral sparing HDR likeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acute toxicity
Incidence of acute toxicity of grade 3 or 4 as maximum toxicity value during the radiation treatment or in any case within a month of the end of SBRT, using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 scale (toxicity from 0- patients without toxicity to 5-death from toxicity)
Time frame
one monthSecondary outcomes
1
Biochemical control
Biochemical control rate at 1,3 and 5 years by measuring Prostate Specific Antigen-PSA- value which must be below (2+nadir) ng/ml
Time frame
5 years (with interim analyzes at 1 and 3 years)2
Biochemical relapse
Biochemical Relapse-Free survival
Time frame
5 years (with interim analyzes at 1 and 3 years)3
Local Control
Local Relapse-Free survival
Time frame
5 years (with interim analyzes at 1 and 3 years)4
Distant Disease Control
Distant Metastases-Free Survival
Time frame
5 years (with interim analyzes at 1 and 3 years)Other outcomes
1
Organ movement
Modeling of organ movements during treatment: Movements of the target and neighboring organs between the treatment fractions and during the treatment will be quantified in millimeters, the median value will be recorded with the range and mean with the standard deviation, and the contributing factors will be identified to find a useful solution
Time frame
3 years2
Radiomics
Evaluation of radiomic characteristics: Mathematical extraction of the spatial distribution of signal intensities and pixel interrelationships of medical images of the patients, to quantify textural information resampled according to International Biomarker Standardization Initiative (IBSI).
Time frame
5 years ( with interim analyzes at 3 years)Sponsors and contacts
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Source ClinicalTrials.gov