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

Official title

2-fraction Stereotactic Body Proton Therapy (SBPT) With Magnetic Resonance Imaging (MRI) Guidance in Localized Prostate Cancer: A Single-arm Phase II Non-randomized Trial

Overview

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.

Detailed description

Proton therapy is an advanced form of radiation that precisely targets tumors while minimizing damage to healthy tissues. However, its high cost has limited patient access. For prostate cancer, studies have already shown that ultra-short radiation courses (as few as 2-5 sessions) using conventional X-ray-based stereotactic body radiation therapy (SBRT) provide excellent results with manageable side effects. This study aims to investigate whether 2-fraction stereotactic body proton therapy (SBPT) with magnetic resonance imaging (MRI) guidance and real-time on-board tumor tracking can achieve similar safety and efficiency as the standard 5-fraction SBPT, with the added benefit of lower costs and greater convenience for patients.

Interventions

• Radiation Pencil Beam Proton Therapy Treatment Machine
  2 fractions will be delivered to treat low- or intermediate- risk prostate cancer

Primary outcome measures

• Clinician-reported grade 2 or above genitourinary and gastrointestinal toxicity [Time frame: 3 months and 24 months after treatment completion with a minimum of 24 months of follow-up and an average of 5 years.]

Secondary outcome measures (5)

• Change in patient reported gastrointestinal and genitourinary symptoms [Time frame: before treatment to 3-months and 24-months after treatment completed]
• Biochemical Progression Free Survival (bPFS) [Time frame: Treatment completion date to 5 years follow-up]
• Distant Metastasis Free Survival [Time frame: Treatment completion date to 5 years follow-up]
• Local Failure-Free Survival (LFFS) [Time frame: Treatment completion date to 5 years follow-up]
• Regional Failure Free Survival (RFFS) [Time frame: Treatment completion date to 5 years follow-up]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

• Hong Kong Sanatorium and Hospital — Hong Kong

Publications

• 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
• 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.202 PMID 37776979
• 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
• 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.2 PMID 39002849
• 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, ph PMID 31227373
• 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, contr PMID 33444529
• 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 c PMID 36113498
• 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

Identifiers

NCT: NCT07130682 · REC-2025-08

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗