Two-fraction Proton Therapy With MRI Guidance for Prostate Cancer: A Phase II Trial

NCT07130682 | Recruiting

• 1 other identifier: REC-2025-08
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study is testing a shorter treatment method for prostate cancer using proton therapy (PT), which is very precise and may cause fewer side effects compared to traditional radiation. However, it is expensive and not easily accessible for many patients. To make it more affordable and accessible, this study is testing whether 2 fractions of stereotactic body proton therapy (SBPT) can be as safe and effective as the standard 5 sessions.

Conditions

Prostate Cancer Patients Treated by Radiotherapy

Keywords

Proton Therapy; Clinician reported outcome; patient reported outcome; low or intermediate risk prostate cancer

Outcome Measures

Primary Outcomes (1)

• Clinician-reported grade 2 or above genitourinary and gastrointestinal toxicity

  Genitourinary and gastrointestinal toxicity were evaluated based on the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) developed by the National Cancer Institute (NCI). Adverse effects within 3 months post-treatment are classified as acute toxicities, while those occurring after 3 months are considered late toxicities.

  3 months and 24 months after treatment completion with a minimum of 24 months of follow-up and an average of 5 years.

Secondary Outcomes (5)

• Change in patient reported gastrointestinal and genitourinary symptoms

  before treatment to 3-months and 24-months after treatment completed

• Biochemical Progression Free Survival (bPFS)

  Treatment completion date to 5 years follow-up

• Distant Metastasis Free Survival

  Treatment completion date to 5 years follow-up

• Local Failure-Free Survival (LFFS)

  Treatment completion date to 5 years follow-up

• Regional Failure Free Survival (RFFS)

  Treatment completion date to 5 years follow-up

Study Arms (1)

2-fraction Proton therapy

EXPERIMENTAL

Radiation: Pencil Beam Proton Therapy Treatment Machine

Interventions

Pencil Beam Proton Therapy Treatment Machine RADIATION

2 fractions will be delivered to treat low- or intermediate- risk prostate cancer

2-fraction Proton therapy

Eligibility Criteria

• Gender Eligibility Details: This study focused on the prostate cancer, which only occur in male.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Men aged \< 18 years with histologically confirmed low- or intermediate-risk prostate cancer per NCCN guidelines
• 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

You may not qualify if:

• History of inflammatory bowel disease or other cancers (except prostate cancer)
• 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

Sponsors & Collaborators

• Hong Kong Sanatorium & Hospital: lead

Study Sites (1)

Hong Kong Sanatorium and Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (10)

• 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.

  PMID: 36633877 BACKGROUND

• 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.

  PMID: 37776979 BACKGROUND

• 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.

  PMID: 37777738 BACKGROUND

• 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.

  PMID: 39002849 BACKGROUND

• 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.

  PMID: 31227373 BACKGROUND

• 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.

  PMID: 33444529 BACKGROUND

• 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.

  PMID: 36113498 BACKGROUND

• 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.

  PMID: 35565400 BACKGROUND

• 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.

  PMID: 34272182 BACKGROUND

• 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.

  PMID: 29735191 BACKGROUND

Central Study Contacts

Oi Lei Wong, Ph.D.

CONTACT

1-852-2917 5550; oilei.ol.wong@hksh.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 19, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): January 2, 2033
• Study Completion (Estimated): June 2, 2033
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)