Condition: Localized Prostate Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05936736

Sponsor: IRCCS San Raffaele

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• 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
• Clinical M0 (PSMA PET/CT and/or bone scan and/or pelvic MRI with and without contrast medium in suspected patients and unfavorable intermediate and high risk patients, according to NCCN guidelines), in the previous 3 months
• Acceptable uroflowmetry: peak urine flow index (peak flow preferably ≥ 15 ml/s), post voiding residue (PVR) ≤50 cc. If lower, acceptable if, by carrying out 3 months of neoadjuvant hormone therapy + alpha-lytic for the reduction of prostate volume, uroflowmetry is reset to at least ≥ 12 ml/s.
• PS (ECOG) ≤2
• No previous pelvic radiotherapy
• Other conditions necessary for the correct execution of the proposed treatment (ability to fill in the questionnaires for the evaluation of the Quality of Life EORTC QLQ-C30, EORTC QLQ-PR25, IPSS, IIEF-5, EPIC 26)

Exclusion Criteria:

• 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)
• Evidence of distant metastases (M1)
• IPSS questionnaire data > 20 points
• Uroflowmetry with maximum basal flow ≤ 11 ml/sec and/or PVR >100 ml
• Concomitant urinary/gastrointestinal inflammatory diseases (e.g. ulcerative colitis, Crohn's disease)
• Overactive bladder
• Impossibility of implantation of fiducials
• Inability or refusal to place bladder catheter for simulation CT and MR
• Inability to perform simulation MRI
• Contraindication for hormonal treatment for patients with unfavorable intermediate, high or very high risk disease
• Non-compliance with dose limits established in the treatment plan

View trial on ClinicalTrials.gov