NCT05936736Recruiting
24 Gy in One Fraction Urethral-sparing "HDR Like" SBRT for Prostate Cancer
24 Gy in One Fraction Urethral-sparing "High-Dose-Rate Like" Stereotactic Body RadioTherapy for Prostate Cancer: a Single-center Non-randomized Prospective Clinical Study (PRO-FAST)
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 20 Jun 2023
- Start date
- 8 Nov 2023
- Primary completion date
- 31 May 2028
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Prostate cancer
- NCT number
- NCT05936736
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 8 Nov 2023 to the primary completion date, 31 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant urinary/gastrointestinal inflammatory diseases (e.g. ulcerative colitis, Crohn's disease)
Other illness
- 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)
- Contraindication for hormonal treatment for patients with unfavorable intermediate, high or very high risk disease
Other
- Evidence of distant metastases (M1)
- IPSS questionnaire data \> 20 points
- Uroflowmetry with maximum basal flow ≤ 11 ml/sec and/or PVR \>100 ml
- Overactive bladder
- Impossibility of implantation of fiducials
- Inability or refusal to place bladder catheter for simulation CT and MR
- Inability to perform simulation MRI
- Non-compliance with dose limits established in the treatment plan
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| San Raffaele Scientific Institute Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.