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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Clinician-reported grade 2 or above genitourinary and gastrointestinal toxicity
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
2-fraction Proton therapy
Intervention: Pencil Beam Proton Therapy Treatment Machine (Radiation)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Regional Failure Free Survival (RFFS)(Treatment completion date to 5 years follow-up)
- 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)