Actively Recruiting
24 Gy in One Fraction Urethral-sparing "HDR Like" SBRT for Prostate Cancer
Led by IRCCS San Raffaele · Updated on 2025-06-08
70
Participants Needed
1
Research Sites
338 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
24 Gy in One Fraction Urethral-sparing "HDR Like" SBRT for Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of prostate adenocarcinoma, ISUP grade groups 1-5
- Patients over 18 years of age
- Signed informed consent
- Negative lymph nodes confirmed by imaging within the previous 3 months
- Clinical M0 status confirmed by imaging within the previous 3 months
- Acceptable uroflowmetry: peak urine flow preferably �3E= 15 ml/s, post voiding residue �3C= 50 cc, or after neoadjuvant hormone therapy and alpha-lytic treatment reset to �3E= 12 ml/s
- Performance status (ECOG) �3C= 2
- No previous pelvic radiotherapy
- Ability to complete quality of life questionnaires (EORTC QLQ-C30, QLQ-PR25, IPSS, IIEF-5, EPIC-26)
You will not qualify if you...
- Serious systemic diseases
- Psychiatric or other disorders preventing informed consent
- Previous invasive cancer except certain skin cancers unless disease-free for 3 years
- Presence of lymph node disease (N1)
- Evidence of distant metastases (M1)
- IPSS questionnaire score above 20
- Uroflowmetry with maximum basal flow �3C= 11 ml/sec and/or post voiding residue above 100 ml
- Concomitant urinary or gastrointestinal inflammatory diseases
- Overactive bladder
- Inability to implant fiducials
- Inability or refusal to place bladder catheter for simulation CT and MRI
- Inability to perform simulation MRI
- Contraindication to hormonal treatment for high-risk disease
- Non-compliance with dose limits in treatment plan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
San Raffaele Scientific Institute
Milan, MI, Italy, 20132
Actively Recruiting
Research Team
A
Andrei Fodor, MD
CONTACT
N
Nadia Di Muzio, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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