Revolutionary Single-Day Prostate Cancer Treatment Shows Promise:


A, Cumulative incidence of bowel grade 1 gastrointestinal (GI) toxic effects. 
B, Cumulative incidence of genitourinary (GU) grade 1 toxic effects. 
C, Cumulative incidence of urinary grade ≥2 toxic effects. 
D, Percentage volume reductions compared to baseline measured by magnetic resonance imaging. Error bars indicate SE; HR, hazard ratio.

The PRO-FAST Study Leads New Wave of Ultra-Hypofractionated SBRT Research

A new frontier in prostate cancer treatment could compress the entire treatment process—from diagnosis to completion—into a single day, according to groundbreaking research from Milan, Italy.

PRO-FAST Study: Complete Treatment in One Day

Researchers at IRCCS San Rafaele Scientific Institute in Milan have launched the PRO-FAST trial (NCT05936736), a pioneering study investigating whether the entire prostate cancer treatment process can be completed in a single day. The study, published in Radiation Oncology in August 2025, represents the most ambitious attempt yet to compress SBRT treatment timelines.

The PRO-FAST protocol delivers a single 24 Gy fraction using "urethral sparing HDR-like" technique with CyberKnife robotic radiosurgery and continuous target tracking. Remarkably, all procedures—fiducial implantation, imaging acquisition, contouring, planning, quality control, and treatment delivery—are performed in one day.

The study follows Simon's optimal two-stage design, enrolling 13 patients initially. Treatment will be halted if two or more patients experience grade 3 or higher toxicity within a month. Otherwise, the study will expand to include 70 patients total.

Growing Evidence for Single-Fraction SBRT

The PRO-FAST study builds on encouraging results from several completed and ongoing single-fraction trials:

ONE SHOT Trial Results

The multicenter ONE SHOT trial, using a single 19 Gy fraction with urethral sparing, recently reported 18-month results showing acceptable toxicity rates. The worst urinary toxicity occurred at day 5 (42.5% grade 1, 20% grade 2), returning to baseline by week 12, with only 7% biochemical failures after median follow-up of 26 months.

PROSINT Trial Success

The PROSINT phase 2 randomized trial compared single-dose 24 Gy radiotherapy versus 5-fraction SBRT in 30 intermediate-risk patients. Results showed SDRT was safe with low toxicity, and tumor control and quality-of-life outcomes closely matched the SBRT arm. With 48 months median follow-up, actuarial 4-year PSA relapse-free survival rates were 85.7% for SBRT versus 77.1% for single-dose treatment.

PACE-B Trial Validates 5-Fraction SBRT

The landmark PACE-B phase 3 trial provided strong validation for ultra-hypofractionated SBRT. The study of 874 patients demonstrated that 5-fraction SBRT (36.25 Gy) was noninferior to conventional radiation therapy for low- and intermediate-risk prostate cancer, with 95.8% 5-year freedom from biochemical/clinical failure versus 94.6% for controls.

Importantly, urinary problems were initially higher in the SBRT group (27% vs 18% at 5 years) but this difference disappeared after 2 years, with most side effects being short-lived and controllable with medications.

CyberKnife Advantage

A significant finding from PACE-B was that CyberKnife SBRT showed fewer urinary side effects compared to conventional linac SBRT (6% vs 17% grade 2+ toxicity at 2 years), despite actually delivering higher planned doses to urinary structures. This suggests that real-time tracking and robotic precision may be crucial advantages for ultra-hypofractionated treatments.

Multiple Single-Fraction Trials Underway

The field is rapidly expanding with numerous active trials:

  • PROSINT II: 200-patient study of 24 Gy single-dose treatment
  • ABRUPT: Testing 21 Gy to whole prostate with 24 Gy boost to visible tumors
  • Multiple institutional studies: Various centers testing single-fraction approaches with doses ranging from 19-24 Gy

Clinical Implications and Patient Benefits

The shift toward ultra-hypofractionation offers several advantages:

  1. Convenience: Reducing treatment from 8-10 weeks to potentially one day eliminates travel burden and work disruptions
  2. Cost-effectiveness: Dramatically reduced healthcare resources and patient costs
  3. Equivalent outcomes: Studies consistently show similar cancer control rates
  4. Quality of life: SBRT patients experience less patient-reported urinary incontinence and sexual dysfunction compared to surgery, with only slightly more bowel toxicity

Current Treatment Guidelines

The National Comprehensive Cancer Network now recommends SBRT as standard treatment for all risk groups, with typical regimens ranging from 35-50 Gy in up to 7 fractions. However, single-fraction treatment remains investigational pending longer-term results.

Expert Perspectives

Dr. Krishnan Patel from NCI's Center for Cancer Research noted: "These data support the use of SBRT as a standard of care for intermediate-risk prostate cancer, but it still may not be for everyone." Patients with larger prostates or existing urinary problems may not be ideal candidates.

Leading radiation oncologists emphasize that while higher doses can be delivered safely in fewer fractions, "it remains unclear whether there is any apparent benefit to this intensive whole-gland dose escalation on quality of life or hard clinical endpoints" compared to standard 5-fraction regimens.

Looking Ahead

The convergence of evidence from multiple trials suggests single-fraction SBRT may become a viable option for carefully selected patients. The PRO-FAST study's ambitious "one-day treatment" approach represents the ultimate goal of convenience and efficiency.

However, longer follow-up data is needed to establish optimal patient selection criteria and ensure long-term safety. The field continues to balance the appeal of convenience with the need for proven long-term outcomes.

Sources and Citations

  1. Fodor, A., Giannini, L., Torrisi, M., et al. (2025). Comprehensive one-day management of prostate cancer patients: PRO-FAST single-fraction ablative, urethral-sparing, HDR-like, robotic SBRT. Radiation Oncology, 20, 134. https://doi.org/10.1186/s13014-025-02713-9
  2. van As, N., Griffin, C., Tree, A., et al. (2024). Phase 3 Trial of Stereotactic Body Radiotherapy in Localized Prostate Cancer. New England Journal of Medicine, 391, 1413-1425. https://doi.org/10.1056/NEJMoa2403365
  3. National Cancer Institute. (2024, October). SBRT Proves Effective for Some Prostate Cancers. Cancer Currents Blog. https://www.cancer.gov/news-events/cancer-currents-blog/2024/prostate-cancer-sbrt-effective-safe
  4. Greco, C., Pares, O., Pimentel, N., et al. (2021). Safety and Efficacy of Virtual Prostatectomy With Single-Dose Radiotherapy in Patients With Intermediate-Risk Prostate Cancer: Results From the PROSINT Phase 2 Randomized Clinical Trial. JAMA Oncology, 7(7), 1031-1039. https://doi.org/10.1001/jamaoncol.2021.0039
  5. Zilli, T., Franzese, C., Guckenberger, M., et al. (2024). ONE SHOT - single shot radiotherapy for localized prostate cancer: 18-month results of a single arm, multicenter phase I/II trial. Radiotherapy and Oncology, 194, 110181. https://doi.org/10.1016/j.radonc.2024.110181
  6. Ratnakumaran, R., Sasitharan, A., Khan, A., et al. (2025). Dosimetric comparison of CyberKnife and conventional linac prostate stereotactic body radiation therapy plans: analysis of the PACE-B study. International Journal of Radiation Oncology, Biology, Physics. https://doi.org/10.1016/j.ijrobp.2025.01.014
  7. Tree, A.C., et al. (2022). Intensity-Modulated Fractionated Radiotherapy Versus Stereotactic Body Radiotherapy for Prostate Cancer (PACE-B): 2-year Toxicity Results From an Open-label, Randomised, Phase III, Non-inferiority Trial. The Lancet Oncology. https://doi.org/10.1016/S1470-2045(22)00517-4
  8. ClinicalTrials.gov. PRO-FAST Study. NCT05936736. https://clinicaltrials.gov/study/NCT05936736
  9. European Society for Medical Oncology. (2024, October). Five Fraction SBRT Noninferior to Moderately Fractionated Image-Guided Radiotherapy. https://www.esmo.org/oncology-news/five-fraction-sbrt-noninferior-to-moderately-fractionated-image-guided-radiotherapy-for-patients-with-low-to-intermediate-risk-localised-prostate-cancer
  10. Accuray Inc. (2024). Prostate Cancer Studies Demonstrate Minimized Toxicity with Ultra-hypofractionated SBRT on the CyberKnife System. https://www.accuray.com/blog/prostate-cancer-studies-demonstrate-minimized-toxicity-with-cyberknife-system/
  11. Comprehensive one-day management of prostate cancer patients: PRO-FAST single-fraction ablative, urethral-sparing, HDR-like, robotic SBRT | Radiation Oncology | Full Text

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