Prostate Cancer Patients Treated by RadiotherapyPT2NCT07130682
Two-fraction Proton Therapy With MRI Guidance for Prostate Cancer: A Phase II Trial
A study testing Pencil Beam Proton Therapy Treatment Machine in people with Prostate Cancer Patients Treated by Radiotherapy, run by Hong Kong Sanatorium & Hospital at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer Patients Treated by Radiotherapy
- What is being tested?
- Pencil Beam Proton Therapy Treatment Machine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2025to 2 Jun 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Sanatorium and Hospital
Hong Kong
Oi Lei Wong, Ph.D., 1-852-2917 5550, penguin.oilei@gmail.com
Darren Ming Chun Poon, Dr.
About this study
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
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.
Read the 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.
- Being tested
- Pencil Beam Proton Therapy Treatment Machine
- Keywords
- Proton Therapy, Clinician reported outcome, patient reported outcome, low or intermediate risk prostate cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pencil Beam Proton Therapy Treatment MachineRadiation
2 fractions will be delivered to treat low- or intermediate- risk prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| 2-fraction Proton therapy | Experimental | Not described Receives: Radiation: Pencil Beam Proton Therapy Treatment Machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Gastrointestinal and genitourinary health-related quality of life (HQOL) are measured using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire, which is a validated comprehensive instrument to measure the health-related quality of life among men with prostate cancer. EPIC consists of 5 primary domains, including urinary function, bowel habits, sexual function, hormonal functions, and overall satisfaction. Responses to each question form a Likert scale and are transformed to a 0-100 scale for each domain and subdomain, higher scores representing better HQOL.
Measured: before treatment to 3-months and 24-months after treatment completed
Biochemical Progression Free Survival (bPFS)
Biochemical progression-free survival (bPFS) among participants will be assessed during clinical follow-up. bPFS is defined as the duration of time a localized prostate cancer patient remains free from biochemical recurrence after treatment. Biochemical recurrence is defined as a prostate-specific antigen (PSA) increase of 2 ng/mL above the nadir based on the Phoenix criteria (nadir + 2 ng/mL), confirmed by a second PSA value obtained three or more weeks later.
Measured: Treatment completion date to 5 years follow-up
Distant Metastasis Free Survival
Distant metastasis (DM) refers to the spread of cancer cells from the prostate to distant sites outside the pelvic region. DF will be assessed during clinical follow-up using prostate-specific membrane antigen positron emission tomography (PSMA-PET), MRI, and/or other clinical imaging in cases of persistent PSA progression or emergence of symptoms. Distant metastasis free survival is defined as the duration of time from treatment completion date to the date of distant metastasis diagnosis by clinical imaging or death.
Measured: Treatment completion date to 5 years follow-up
Local Failure-Free Survival (LFFS)
Local Failure (LF) refers to recurrent prostatic mass diagnosed by digital rectal examination, clinical imaging techniques like PSMA-PET and/or MRI, or histopathological confirmation of recurrence by biopsy. Local failure-free survival is defined as the duration of time from treatment completion date to date of local failure diagnosis or death.
Measured: Treatment completion date to 5 years follow-up
Regional Failure Free Survival (RFFS)
Regional Failure (RF) refers to recurrent in the regional lymph nodes diagnosed by clinical imaging techniques like PSMA-PET and/or MRI. Regional failure-free survival is defined as the duration of time from treatment completion date to date of regional failure diagnosis or death.
Measured: Treatment completion date to 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Sep 2025
- Primary completion2 Jan 2033 (estimated)
- Study completion2 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer Patients Treated by RadiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Sanatorium & Hospital
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130682
- Sponsor's protocol ID
- REC-2025-08
- Acronym
- PT2
- Status last verified
- Mar 2026
- First submitted
- 28 Jul 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD cannot be shared due to hospital policy, which restricts the sharing of patient data-even in de-identified or masked form-to ensure compliance with privacy regulations and ethical safeguards.
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.
PubMed 36633877Westley 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.
PubMed 37776979Wolfe 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.
PubMed 37777738Fredman 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.
PubMed 39002849Widmark 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.
PubMed 31227373Fransson 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.
PubMed 33444529Tree 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.
PubMed 36113498Santos 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.
PubMed 35565400Vidal 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.
PubMed 34272182Schippers 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.
PubMed 29735191
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07130682
- Acronym / sponsor ID
- PT2 / REC-2025-08
- Keywords
- Proton Therapy, Clinician reported outcome, patient reported outcome, low or intermediate risk prostate cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Hong Kong Sanatorium & HospitalIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 2 Jan 2033 (estimated)
- Study completion
- 2 Jun 2033 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2-fraction Proton therapy | Experimental | Radiation: Pencil Beam Proton Therapy Treatment Machine |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pencil Beam Proton Therapy Treatment Machine2 fractions will be delivered to treat low- or intermediate- risk prostate cancer | Radiation | 2-fraction Proton therapy |
Primary outcome
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.
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 36633877Kishan 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.
- Background: PubMed 37776979Westley 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.
- Background: PubMed 37777738Wolfe 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.
- Background: PubMed 39002849Fredman 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.
- Background: PubMed 31227373Widmark 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.
- Background: PubMed 33444529Fransson 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.
- Background: PubMed 36113498Tree 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.
- Background: PubMed 35565400Santos 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.
- Background: PubMed 34272182Vidal 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.
- Background: PubMed 29735191Schippers 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.
- Individual participant dataSharing planned: No. The IPD cannot be shared due to hospital policy, which restricts the sharing of patient data-even in de-identified or masked form-to ensure compliance with privacy regulations and ethical safeguards.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pencil Beam Proton Therapy Treatment Machine in people with Prostate Cancer Patients Treated by Radiotherapy, run by Hong Kong Sanatorium & Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oi Lei Wong, Ph.D. (1-852-2917 5550, oilei.ol.wong@hksh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07130682, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.