Prostate Advances in Comparative Evidence (PACE)

Inclusion Criteria: All of the following criteria are mandatory for inclusion:

• Histological confirmation of prostate adenocarcinoma with a minimum of 10 biopsy cores taken within 18 months of randomisation.
• Gleason score ≤ 3+4
• Men aged ≥18
• Clinical and MRI stage T1c -T2c, N0-X, M0-X (TNM 6th Edition [72], See Appendix 1)
• PSA ≤ 20 ng/ml
• Pre-enrollment PSA must be completed within 60 days of randomisation

• Patients belonging in one of the following risk groups according to the National Comprehensive Cancer Network (www.nccn.org):

  • 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 orT2c
  • PSA 10-20 ng/ml or
  • Gleason 3+4
• WHO performance status 0 - 2
• Prostate volume ≤ 90 cc measured within 6 months of randomisation (height*width*length *π/6)
• Ability of the research subject to understand and the willingness to sign a written informed consent document

Exclusion criteria: One of the following criteria is sufficient for exclusion:

• Clinical stage T3 or greater
• Gleason score ≥ 4 + 3
• High risk disease defined by National Comprehensive Cancer Network (www.nccn.org)
• Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival
• Prior pelvic radiotherapy
• Prior androgen deprivation therapy (including LHRH agonists and antagonists and anti-androgens)
• Any prior active treatment for prostate cancer. Patients previously on active surveillance are eligible if they continue to meet all other eligibility criteria.
• Life expectancy <5 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/ bleeding tendency making fiducial placement or surgery unsafe in the opinion of the clinician (see section 11, Treatment).
• Participation in another concurrent treatment protocol for prostate cancer