24 Gy in One Fraction Urethral-sparing "HDR Like" SBRT for Prostate Cancer
Recruiting · NCT05936736 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
Where it is running
1 location listed.
- San Raffaele Scientific Institute - Milan, MI, Italy