High-dose single fraction radiation therapy 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)
This study is testing a high-dose radiation treatment for localized prostate cancer to see if it is safe and effective while protecting the urethra.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | IRCCS San Raffaele Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT05936736 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a single fraction of 24 Gy high-dose-rate radiation therapy that spares the urethra in patients with localized prostate cancer. Participants will undergo staging exams, including PSMA PET/CT scans, and if eligible, will receive treatment after fiducial implantation and imaging simulations. The study aims to assess acute and late toxicity, biochemical control, overall survival, cancer-specific survival, and quality of life through questionnaires in a total of 70 patients. The trial is designed to monitor toxicity levels closely to ensure patient safety.
Who should consider this trial
Good fit: Ideal candidates include adult males diagnosed with localized prostate adenocarcinoma who meet specific imaging and uroflowmetry criteria.
Not a fit: Patients with distant metastases or significant urinary flow issues that cannot be corrected may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective treatment option for patients with localized prostate cancer.
How similar studies have performed: While similar approaches have been explored, this specific urethral-sparing technique in a single fraction setting is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan, MI
- San Raffaele Scientific Institute — Milan, Mi, Italy (Recruiting)
Study contacts
- Study coordinator: Andrei Fodor, MD
- Email: fodor.andrei@hsr.it
- Phone: +390226437634
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.