International Randomised Study of Laparoscopic Prostatectomy vs Stereotactic Body Radiotherapy (SBRT) and Conventionally Fractionated Radiotherapy vs SBRT for Early Stage Organ-Confined Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01584258

Sponsor: Royal Marsden NHS Foundation Trust

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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

View trial on ClinicalTrials.gov