Study on Shortened Proton Therapy with Internal Radiation Boost for High-Risk Prostate Cancer

Inclusion Criteria

• Diagnosed with prostate cancer.
• Classified as high-risk or unfavorable intermediate-risk based on specific medical criteria:
  • High risk: Stage T3a, Gleason Grade Group 4/5, or PSA level over 20.
  • Unfavorable intermediate risk: Stage T2b-T2c, Gleason Grade Group 2/3, PSA level between 10-20, or more than 50% of biopsy samples positive.
• Suitable for whole pelvis treatment as determined by the oncologist or a specific prediction tool.
• Eligible for external beam radiotherapy:
  • No previous radiotherapy in the treatment area.
  • No inflammatory bowel disease or active connective tissue disorders.
• Aged 18 years or older.
• General health status allowing normal activity or some restriction (ECOG score 0-2).
• May start hormone therapy up to 3 months before, during, or after radiation therapy. Duration of hormone therapy varies by risk level.
• Undergo a pre-treatment evaluation including:
  • Medical history and physical exam by a radiation oncologist within 6 weeks of joining the study.
  • MRI of the prostate.
  • PSMA PET scan.
  • PSA blood test.
• Eligible for a procedure to place a rectal spacer, as determined by the doctor.
• Must understand and agree to the study's requirements and risks by signing an informed consent form.

Exclusion Criteria

• Evidence of cancer spread to distant parts of the body.
• History of inflammatory bowel disease or active connective tissue disorders.
• Previous radiation treatment to the pelvis.
• Another invasive cancer, unless disease-free for at least five years, except for non-melanoma skin cancer.
• Severe, active health issues that could interfere with the study or treatment.
• History of a specific prostate surgery (TURP).
• High urinary symptoms score (IPSS over 20) or on maximum medication for urinary symptoms.
• On blood thinners for medical treatment.