Two-fraction Proton Therapy With MRI Guidance for Prostate Cancer: A Phase II Trial
NCT ID: NCT07130682
Last Updated: 2025-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
35 participants
INTERVENTIONAL
2025-09-01
2033-06-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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2-fraction Proton therapy
Pencil Beam Proton Therapy Treatment Machine
2 fractions will be delivered to treat low- or intermediate- risk prostate cancer
Interventions
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Pencil Beam Proton Therapy Treatment Machine
2 fractions will be delivered to treat low- or intermediate- risk prostate cancer
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status \<2
* Ability to undergo magnetic resonance imaging (MRI) simulation scans without absolute contraindications, such as cardiac implantable electronic devices
* Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
Exclusion Criteria
* Prior pelvic radiotherapy, chemotherapy, radical prostatectomy, cryosurgery, or focal therapy (e.g. high-intensity focused ultrasound \[HIFU\]) for prostate cancer
* History of bladder neck or urethral stricture
* Transurethral resection of the prostate (TURP) \< 8 weeks prior to SBPT
* Prostate volume \> 100cc on MRI
* Unilateral or bilateral hip replacements
* Nodal or distant metastases, as indicated by computed tomography (CT), MRI, or prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scans
* Previous androgen deprivation therapy (ADT) lasting more than 6 months
MALE
No
Sponsors
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Hong Kong Sanatorium & Hospital
INDUSTRY
Responsible Party
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Locations
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Hong Kong Sanatorium and Hospital
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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References
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Kishan AU, Ma TM, Lamb JM, Casado M, Wilhalme H, Low DA, Sheng K, Sharma S, Nickols NG, Pham J, Yang Y, Gao Y, Neylon J, Basehart V, Cao M, Steinberg ML. Magnetic Resonance Imaging-Guided vs Computed Tomography-Guided Stereotactic Body Radiotherapy for Prostate Cancer: The MIRAGE Randomized Clinical Trial. JAMA Oncol. 2023 Mar 1;9(3):365-373. doi: 10.1001/jamaoncol.2022.6558.
Westley RL, Biscombe K, Dunlop A, Mitchell A, Oelfke U, Nill S, Murray J, Pathmanathan A, Hafeez S, Parker C, Ratnakumaran R, Alexander S, Herbert T, Hall E, Tree AC. Interim Toxicity Analysis From the Randomized HERMES Trial of 2- and 5-Fraction Magnetic Resonance Imaging-Guided Adaptive Prostate Radiation Therapy. Int J Radiat Oncol Biol Phys. 2024 Mar 1;118(3):682-687. doi: 10.1016/j.ijrobp.2023.09.032. Epub 2023 Sep 29.
Wolfe S, Diven MA, Marciscano AE, Zhou XK, Kishan AU, Steinberg ML, Miccio JA, Camilleri P, Nagar H. A randomized phase II trial of MR-guided prostate stereotactic body radiotherapy administered in 5 or 2 fractions for localized prostate cancer (FORT). BMC Cancer. 2023 Sep 30;23(1):923. doi: 10.1186/s12885-023-11430-z.
Fredman E, Moore A, Icht O, Tschernichovsky R, Shemesh D, Bragilovski D, Kindler J, Golan S, Shochet T, Limon D. Acute Toxicity and Early Prostate Specific Antigen Response After Two-Fraction Stereotactic Radiation Therapy for Localized Prostate Cancer Using Peri-Rectal Spacing-Initial Report of the SABR-Dual Trial. Int J Radiat Oncol Biol Phys. 2024 Dec 1;120(5):1404-1409. doi: 10.1016/j.ijrobp.2024.06.038. Epub 2024 Jul 11.
Widmark A, Gunnlaugsson A, Beckman L, Thellenberg-Karlsson C, Hoyer M, Lagerlund M, Kindblom J, Ginman C, Johansson B, Bjornlinger K, Seke M, Agrup M, Fransson P, Tavelin B, Norman D, Zackrisson B, Anderson H, Kjellen E, Franzen L, Nilsson P. Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial. Lancet. 2019 Aug 3;394(10196):385-395. doi: 10.1016/S0140-6736(19)31131-6. Epub 2019 Jun 18.
Fransson P, Nilsson P, Gunnlaugsson A, Beckman L, Tavelin B, Norman D, Thellenberg-Karlsson C, Hoyer M, Lagerlund M, Kindblom J, Ginman C, Johansson B, Bjornlinger K, Seke M, Agrup M, Zackrisson B, Kjellen E, Franzen L, Widmark A. Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer (HYPO-RT-PC): patient-reported quality-of-life outcomes of a randomised, controlled, non-inferiority, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):235-245. doi: 10.1016/S1470-2045(20)30581-7. Epub 2021 Jan 11.
Tree AC, Ostler P, van der Voet H, Chu W, Loblaw A, Ford D, Tolan S, Jain S, Martin A, Staffurth J, Armstrong J, Camilleri P, Kancherla K, Frew J, Chan A, Dayes IS, Duffton A, Brand DH, Henderson D, Morrison K, Brown S, Pugh J, Burnett S, Mahmud M, Hinder V, Naismith O, Hall E, van As N; PACE Trial Investigators. Intensity-modulated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): 2-year toxicity results from an open-label, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2022 Oct;23(10):1308-1320. doi: 10.1016/S1470-2045(22)00517-4. Epub 2022 Sep 13.
Santos A, Penfold S, Gorayski P, Le H. The Role of Hypofractionation in Proton Therapy. Cancers (Basel). 2022 May 2;14(9):2271. doi: 10.3390/cancers14092271.
Vidal M, Moignier C, Patriarca A, Sotiropoulos M, Schneider T, De Marzi L. Future technological developments in proton therapy - A predicted technological breakthrough. Cancer Radiother. 2021 Oct;25(6-7):554-564. doi: 10.1016/j.canrad.2021.06.017. Epub 2021 Jul 13.
Schippers JM, Lomax A, Garonna A, Parodi K. Can Technological Improvements Reduce the Cost of Proton Radiation Therapy? Semin Radiat Oncol. 2018 Apr;28(2):150-159. doi: 10.1016/j.semradonc.2017.11.007.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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REC-2025-08
Identifier Type: -
Identifier Source: org_study_id
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