Vessel Sparing Prostate Radiation Therapy
Condition: Cancer of the PROSTATE
MeSH terms: Prostatic Neoplasms
Intervention: Radiation Therapy
Intervention description: Radiation Therapy Using MRI Based Treatment Planning
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 135.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Prostate cancer patients have a number of excellent treatment options to consider, and
      quality of life following treatment is often a consideration in treatment choice. One
      critical quality of life concern for patients diagnosed with prostate cancer is sexual
      function. Previous studies point to a vascular mechanism of impotence post-radiation therapy,
      as opposed to a nerve-based mechanism following surgery. In this study, the critical vascular
      structures (internal pudendal artery and corpus cavernosum) are defined by MRI-based imaging
      and included in treatment planning for radiation treatments, hopefully preserving critical
      artery function. This study will collect erectile function preservation rates at 5-years
      post-vessel-sparing radiotherapy with or without aids using the patient reported using the
      simplified three-question erectile function scale.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of prostate cancer

          -  Patients must have measurable erectile function. Patients with erectile function on
             Viagra and drugs of the same class are eligible. Patients who require 6 months of
             hormonal therapy or less are eligible, provided baseline erectile function is measured
             prior to or within 14 days of the start of hormonal therapy.

          -  Baseline PSA (Prostate Specific Antigen), TNM stage (a classification of malignant
             tumors in cancer), and Gleason Score (A system of grading prostate cancer tissue based
             on how it looks under a microscope): Patients with low (PSA less than 10, T2a or less,
             Gleason 6 or less), intermediate, or high (Gleason 8-10, T3a, PSA over 20) risk
             disease are eligible for this protocol. Patients on finasteride or drugs of the same
             class are eligible.

          -  Patients must be 18 years or older. No upper age restriction.

          -  Patients treated with external beam radiotherapy alone or external beam therapy plus
             implant therapy are eligible.

          -  Patients must have an ECOG (Eastern Cooperative Oncology Group system of grading
             patient status that attempts to quantify cancer patients' general well-being and
             activities of daily life) performance status <2.

          -  The patient must sign study specific informed consent approved by the IRB of U of M
             indicating they are aware of the investigational nature of the treatment.

        Exclusion Criteria:

          -  Patients who are impotent or have an IIEF (International Index of Erectile Function)
             <16.

          -  Patients who are medically ineligible for radiation therapy due to other medical
             conditions.

          -  Patients given hormonal therapy before baseline questionnaires filled out.

          -  Patients who receive implant only therapy.

          -  Patients unable to undergo MRI (Magnetic Resonance Imaging).