Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer

Launched by VARIAN, A SIEMENS HEALTHINEERS COMPANY · Mar 26, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to deliver radiation therapy for men with low to intermediate risk prostate cancer. The researchers want to see if an individualized approach that protects the urethra (the tube that carries urine from the bladder) can reduce the number of urinary side effects that patients experience during and after treatment. Patients will be asked to fill out a questionnaire to help measure any changes in their urinary health compared to what has been reported in previous studies using standard treatment methods.

To participate, men must be at least 18 years old and have a confirmed diagnosis of low or intermediate risk prostate cancer. They should have a prostate size of 80cc or less and a specific score on a urinary symptom assessment. Participants will need to be able to complete questionnaires and provide informed consent. However, individuals with certain health issues, past treatments, or specific conditions may not be eligible. If you join this trial, you can expect close monitoring and support as you receive this personalized treatment for your prostate cancer.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient has NCCN low or intermediate risk prostate cancer that is biopsy proven.
• • 2. Prostate volume is ≤80cc as assessed by MRI prior to radiotherapy.
• • 3. AUA/IPSS score is ≤ 15.
• • 4. ECOG performance status is ≤2 (or Karnofsky score is ≥60%).
• • 5. Patient has no PIRADS 4 or 5 lesion on prostate MRI contacting the urethra (determined at physician discretion).
• • 6. Patient has the ability to complete required patient questionnaires.
• • 7. Patient age ≥ 18 years (or greater than the local age of majority).
• • 8. Patient has the ability to understand and the willingness to sign a written informed consent document.
• Exclusion Criteria:
• • 1. Patient has baseline grade ≥3 GI or GU toxicity
• • 2. Patient has had prior overlapping pelvic radiotherapy.
• • 3. Patient has had prior transurethral resection of the prostate, prostate HIFU, or cryoablation.
• • 4. Patient has node positive prostate cancer.
• • 5. Patient has extracapsular extension (capsular abutment is permitted).
• • 6. Patient has active inflammatory bowel disease or active collagen vascular disease.
• • 7. Patient cannot undergo prostate MRI.
• • 8. Patient cannot undergo prostate fiducial marker placement.
• • 9. Patient has ongoing receipt of cytotoxic chemotherapy (androgen deprivation therapy is allowed).