Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 Aug 27;20(1):134.
doi: 10.1186/s13014-025-02713-9.

Comprehensive one-day management of prostate cancer patients: PRO-FAST single-fraction ablative, urethral-sparing, HDR-like, robotic SBRT

Andrei Fodor  1 , Laura Giannini  2 , Miriam Torrisi  2 , Chiara Brombin  3   4 , Sara Broggi  5 , Andrea Losa  6 , Tommaso Maga  6 , Renata Mellone  7 , Carlo Martinenghi  7 , Roberta Tummineri  2 , Paola Mangili  5 , Chiara Lucrezia Deantoni  2 , Alessia Tudda  5 , Roberta Castriconi  5 , Paola Maria Vittoria Rancoita  3   4 , Mariaclelia Stefania Di Serio  3   4 , Franco Gaboardi  6 , Claudio Fiorino  5 , Antonella Del Vecchio  5 , Arturo Chiti  4   8 , Francesco De Cobelli  4   7 , Nadia Di Muzio  2   4
Affiliations
Clinical Trial

Comprehensive one-day management of prostate cancer patients: PRO-FAST single-fraction ablative, urethral-sparing, HDR-like, robotic SBRT

Andrei Fodor et al. Radiat Oncol. .

Abstract

Background: Radiotherapy (RT) is a standard curative treatment for prostate cancer (PCa) and there is growing evidence of the high efficacy of moderate and ultra-hypofractionated RT. Reducing treatment duration to one week or less is a major advance, but very few studies have explored single-fraction therapy. This study evaluates the feasibility, safety, and efficacy of single-fraction stereotactic body RT (SBRT) while delivering the entire procedure in one day, with a potentially high benefit in terms of patient comfort and therapy cost and logistics.

Methods: This prospective, non-randomized monocentric trial uses Robotic Radiosurgery (CyberKnife v.7 system) to deliver a single 24 Gy fraction to the prostate (± seminal vesicles) with a "urethral sparing HDR-like" technique, and target tracking. The first phase will enroll 13 PCa patients following Simon's optimal design. Treatment is to be stopped if ≥ 2 patients develop ≥ G3 toxicity (CTCAE v5.0) within a month from RT end; otherwise, 52 more patients will be added, totaling 65. To account for minimal drop-out, 5 extra patients will be enrolled, reaching 70. All procedures are performed in a single day, including fiducial implantation, imaging acquisition, contouring, planning, dosimetry quality control, and treatment. Apart from treatment feasibility in terms of one-month acute toxicity, secondary endpoints include late toxicity, biochemical and clinical control.

Discussion: Few others have investigated the 24 Gy single-fraction schedule using different delivery modalities (not including tracking), which has proved to be non-inferior to 5 fraction SBRT. Our approach aims to maintain (and possibly improve) the previously reported acute, subacute and late toxicity as well as disease control, adding evidence in favor of single-fraction delivery. Another significant goal of the study is the demonstration that all the complex treatment procedures can be safely delivered in a single day. This would be especially appealing for patients far from radiotherapy centers and those with work commitments not allowing daily hospital visits. The study of response to RT can also provide useful information about PCa radiobiology. Planned additional analyses may help in better assessing the clinical value of PSMA PET/CT in the selection of high-risk patients with true limited disease, and in identifying radiomic features associated to outcome.

Trial registration: The study was prospectively registered at clinicaltrials.gov (NCT05936736).

Keywords: Clinical prospective trial; PSMA PET/CT; Prostate cancer; Single fraction; Stereotactic body radiotherapy; T2 weighted MRI.

PubMed Disclaimer

Conflict of interest statement

Declarations. Ethics approval and consent to participate: All procedures performed in the present study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies using animals performed by any of the authors. This study has been approved by the Institutional Scientific Board of the IRCCS San Raffaele Scientific Institute (registration number 27/INT//2023). All participants will sign an Informed Consent. Consent for publication: Not applicable. Competing interests: Miriam Torrisi and Roberta Tummineri received a speaker honorarium from Accuray Inc. independently from the current work. Laura Giannini received a research fellowship from AIRC: IG 25951-project “Toward clinical use of PET in selecting patients with pancreatic cancer for local treatment intensification”. Miriam Torrisi received a research grant from the Next Generation EU (PNRR-MCNT2-2023-12378239), with a project entitled “Radio-immunotherapy in solid tumors” (CUP Code: C43C24000320005). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The remaining authors declare no conflicts of interest.

References

    1. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: prostate cancer. Version 1.2025: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf - PubMed
    1. Hamdy FC, Donovan JL, Lane JA, et al. 10-year outcomes after monitoring, surgery, or radiotherapy for localized prostate cancer. New Engl J Med. 2016;375:1415–24. - PubMed
    1. Donovan JL, Hamdy FC, Lane JA, et al. Pateint-reported outcomes after monitoring, surgery, or radiotherapy for prostate cancer. N Engl J Med. 2016;375:1425–37. - PMC - PubMed
    1. Parker C, Castro E, Fizazi K, et al. Prostate Cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020;31(9):1119–34. - PubMed
    1. Prada PJ, Cardenal J, Blanco AG, et al. High-dose-rate interstitial brachytherapy as monotherapy in one fraction for the treatment of favorable stage prostate cance: toxicity and long-term biochemical results. Radiother Oncol. 2016;119(3):411–6. - PubMed

Publication types

MeSH terms

Associated data