PACE

 Prostate Cancer / Posted 1 year ago

A trial comparing surgery, conventional radiotherapy and stereotactic radiotherapy for localised prostate cancer (PACE)

If prostate cancer is diagnosed before it has spread outside the prostate gland, there are several treatment options including surgery to remove the prostate gland, external radiotherapy and internal radiotherapy (brachytherapy). Some men may now also be offered a new way of having external radiotherapy called stereotactic radiotherapy. You have stereotactic radiotherapy over a shorter period of time than conventional radiotherapy.
All of the treatments listed above work well, but doctors don’t know if one is better than the other or which one has the fewest side effects.
In this trial, some men will have keyhole surgery to remove the prostate gland (laparoscopic prostatectomy), some will have conventional radiotherapy and some will have stereotactic radiotherapy.
The aim of the study is to compare the different treatments to find out
How long men live after each treatment without any sign of their cancer coming back
More about the side effects of each treatment

  • Inclusion Criteria :
    • Histological confirmation of prostate adenocarcinoma with a minimum of 10 biopsy cores taken within last 18 months (unless on active surveillance and not clinically indicated).
    • 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 (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 7 (3+4 for PACE)
    • WHO performance status 0 - 2
    • Ability of the research subject to understand and the willingness to sign a written informed consent document
  • Exclusion Criteria :
    • 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 androgen agonists and antagonists)
    • 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.
    • Medical condition/ implant that prohibits MRI
    • Participation in another concurrent treatment protocol
  • Study start date : 01/08/2012
  • Study end date : 31/12/2020
  • Wales-Based Study Contact : please speak to your clinician
  • Principal Investigator : Dr Nicholas Van As
Contact details

Velindre and Betsi Cadwaladr (Glan Clwyd Hospital)Wales Wide pace-icrctsu@icr.ac.uk www.cancerresearchuk.org

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