NCT07130682 Two-fraction Proton Therapy With MRI Guidance for Prostate Cancer: A Phase II Trial
| NCT ID | NCT07130682 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hong Kong Sanatorium & Hospital |
| Condition | Prostate Cancer Patients Treated by Radiotherapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2033-01-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2025-09-01 with a primary completion date of 2033-01-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07130682 clinical trial?
This trial is open to male participants only, studying Prostate Cancer Patients Treated by Radiotherapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07130682 currently recruiting?
Yes, NCT07130682 is actively recruiting participants. Contact the research team at oilei.ol.wong@hksh.com for enrollment information.
Where is the NCT07130682 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT07130682 clinical trial?
NCT07130682 is sponsored by Hong Kong Sanatorium & Hospital. The trial plans to enroll 35 participants.
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