Prostate Advances in Comparative Evidence (PACE)

Inclusion Criteria:

• Histological confirmation of prostate adenocarcinoma with a minimum of 10 biopsy cores taken.
• Gleason score ≤ 3+4
• Men aged ≥18
• Clinical and MRI stage T1c -T2c, N0-X, M0-X
• PSA ≤ 20 ng/mL
• Pre-enrollment PSA must be completed within 60 days of registration

• Patients belonging in one of the following risk groups according to the National Comprehensive Cancer Network:

  • Low risk: Clinical stage T1-T2a and Gleason ≤ 6 and PSA < 10 ng/ml, or

  • Intermediate risk includes any one of the following:

    • Clinical stage T2b or T2c
    • PSA 10-20 ng/ml or
    • Gleason 7
• WHO performance status 0 - 2
• Prostate volume ≤ 90 cc
• Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Clinical stage T3 or greater
• Gleason score ≥ 4 + 3
• < 10 prostate biopsies taken
• High risk disease as defined by National Comprehensive Cancer Network (www.nccn.org)
• Previous malignancy within last 5 years except basal cell carcinoma or squamous cell carcinoma of the skin
• Prior pelvic radiotherapy
• Prior androgen deprivation therapy (including androgen agonists and antagonists)
• Any prior active treatment for prostate cancer
• Life expectancy <10 years
• Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artifacts
• Medical conditions likely to make radiotherapy inadvisable eg inflammatory bowel disease, significant urinary symptoms
• Anticoagulation with warfarin or bleeding tendency making fiducial placement unsafe.
• Medical condition/ implant that prohibits MRI
• Comorbidity that excludes surgery (patients can still be entered into radiotherapy randomization arm)