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

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

Conditions2

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