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NCT01584258Active, not recruitingPhase 3

Prostate Advances in Comparative Evidence

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

Source: ClinicalTrials.gov · Last updated 19 Jan 2024

Brief summary (registry, in English)

This study is an international multicentre randomised study of low, intermediate, and high risk prostate cancer and is composed of three parallel randomisation schemes based on applicability of surgery as a treatment for the patient and risk group. Low and intermediate risk patients, for whom surgery is a consideration, are randomised to either prostatectomy or prostate SBRT. Low and intermediate risk patients, for whom surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Intermediate and high risk patients, for whom ADT treatment is indiacted and surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Efficacy, toxicity and quality of life outcomes will be compared across the pairs in each randomisation.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
2205 (actual)
First submitted
22 Apr 2012
Start date
7 Aug 2012
Primary completion date
Dec 2025
Lead sponsor
Royal Marsden NHS Foundation Trust
NCT number
NCT01584258

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 2205
  • From 7 Aug 2012 to the primary completion date, Dec 2025
  • 68 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior pelvic radiotherapy.
  • Prior androgen deprivation therapy (including androgen agonists and antagonists) for PACE-A and PACE-B participants.
  • Any prior active treatment for prostate cancer (with the exception of ADT for PACE-C participants). Patients previously on active surveillance are eligible if they continue to meet all other eligibility criteria.
  • Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts.
  • Participation in another concurrent treatment protocol for prostate cancer.
    • Specific exclusion criteria for PACE-C:
  • \>14 weeks of androgen deprivation therapy prior to randomisation

Other illness

  • 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.
  • Medical conditions likely to make radiotherapy inadvisable eg inflammatory bowel disease, significant urinary symptoms.
  • For patients having fiducials inserted: Anticoagulation with warfarin/ bleeding tendency making fiducial placement or surgery unsafe in the opinion of the clinician.
  • Medical conditions likely to make ADT inadvisable (e.g. significant and ongoing cardiac issues).

Age

  • Life expectancy \<5 years.

Criteria the registry did not label

  • Inclusion critieria (all arms):
  • Histological confirmation of prostate adenocarcinoma within the last 18 months (unless on active surveillance and not clinically indicated)
  • Men aged ≥18 years at randomisation
  • WHO performance status 0 - 2
  • Patients considered candidates for surgery are eligible for PACE-A; patients not considered candidates for surgery and patients who decline surgery or prefer to avoid surgery are eligible for PACE-B and PACE-C.
  • Ability of the research subject to understand and the willingness to sign a written informed consent document.
    • Specific risk stratification inclusion criteria for PACE-A and PACE-B:
  • Minimum of 10 biopsy cores.
  • Gleason score ≤ 3+4
  • Clinical and/or MRI stage T1c -T2c, N0-X, M0-X
  • PSA ≤ 20 ng/ml (completed within 60 days of randomisation)
  • Patients belonging to one of the following risk groups:
  • Low risk - patients with tumours meeting all of the following criteria:
    • Gleason ≤ 6
    • Clinical stage T1-T2a
    • PSA \< 10 ng/ml (within 60 days prior to randomisation)
  • Intermediate risk - patients with tumours meeting any one of the following criteria:
    • Gleason 3+4
    • Clinical stage T2b or T2c
    • PSA 10-20 ng/ml (within 60 days prior to randomisation)
    • Specific risk stratification inclusion criteria for PACE-C:
  • Patient planned for a minimum of 6 months ADT (maximum of 12 months). Patients receiving extended androgen deprivation therapy (18 months maximum) to permit safe delay of radiotherapy as a result of the COVID19 pandemic (only) are eligible.
  • Gleason score ≤ 4+4
  • MRI stage T1c -T3a, N0-X, M0-X
  • PSA ≤ 30 ng/ml (within 60 days prior to starting ADT)
  • Patients belonging to one of the following risk groups:
  • Intermediate risk - includes the presence of any of the following, assuming no high risk features apply:
    • Gleason 7 (3+4 or 4+3)
    • T2 (N0, M0-X)
    • PSA 10-20 ng/ml
  • High risk - patients with tumours that meet a maximum of 2 of the following criteria:
    • Gleason 4+4 (max ≤ 50% cores)
    • T3a (N0, M0)
    • PSA \>20 ng/ml

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (68)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Northeast Cancer Centre
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Greater SudburyCanadaUnknown status
Juravinski Cancer Centre
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HamiltonCanadaUnknown status
London Health Sciences Centre
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LondonCanadaUnknown status
Hôpital Maisonneuve-Rosemont
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MontrealCanadaUnknown status
Hôpital Charles-LeMoyne
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MontrealCanadaUnknown status
Walker Family Cancer Centre
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NiagaraCanadaUnknown status
Lakeridge Health
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OshawaCanadaUnknown status
The Ottawa Hospital Cancer Centre
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OttawaCanadaUnknown status
Odette Cancer Centre
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TorontoCanadaUnknown status
Royal United Hospital
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BathUnited KingdomUnknown status
Belfast City Hospital
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BelfastUnited KingdomUnknown status
Queen Elizabeth Hospital
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BirminghamUnited KingdomUnknown status
Pilgrim Hospital
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BostonUnited KingdomUnknown status
Royal Sussex County Hospital
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BrightonUnited KingdomUnknown status
Bristol Haematology and Oncology Centre
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BristolUnited KingdomUnknown status
West Suffolk Hospital
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BuryUnited KingdomUnknown status
Addenbrooke's Hospital
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CambridgeUnited KingdomUnknown status
Queen Elizabeth Hospital
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CambridgeUnited KingdomUnknown status
Kent and Canterbury Hospital
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CanterburyUnited KingdomUnknown status
Velindre Cancer Centre
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CardiffUnited KingdomUnknown status
Velindre Hospital
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CardiffUnited KingdomUnknown status
Cheltenham General Hospital
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CheltenhamUnited KingdomUnknown status
Colchester General Hospital
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ColchesterUnited KingdomUnknown status
University Hospital Coventry & Warwickshire NHS Trust
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CoventryUnited KingdomUnknown status
Royal Derby Hospital
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DerbyUnited KingdomUnknown status
Western General
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EdinburghUnited KingdomUnknown status
Royal Devon and Exeter Hospital
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ExeterUnited KingdomUnknown status
The Beatson
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GlasgowUnited KingdomUnknown status
Royal Surrey County Hospital
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GuildfordUnited KingdomUnknown status
Hinchingbrooke Hospital
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HuntingdonUnited KingdomUnknown status
Ipswich Hospital
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IpswichUnited KingdomUnknown status
Leicester Royal Infirmary
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LeicesterUnited KingdomUnknown status
Lincoln County Hospital
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LincolnUnited KingdomUnknown status
Guy's Hospital
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LondonUnited KingdomUnknown status
University College Hospital
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LondonUnited KingdomUnknown status
Royal Free Hospital
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LondonUnited KingdomUnknown status
Mount Vernon Cancer Centre
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LondonUnited KingdomUnknown status
Royal Marsden NHS Foundation Trust
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LondonUnited KingdomUnknown status
Charing Cross Hospital
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LondonUnited KingdomUnknown status
Imperial College London
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LondonUnited KingdomUnknown status
St. Bartholomew's Hospital
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LondonUnited KingdomUnknown status
North Middlesex University Hospital
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LondonUnited KingdomUnknown status
Maidstone Hospital
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MaidstoneUnited KingdomUnknown status
Christie Hospital
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ManchesterUnited KingdomUnknown status
Clatterbridge Cancer Centre
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Metropolitan Borough of WirralUnited KingdomUnknown status
James Cook University Hospital
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MiddlesbroughUnited KingdomUnknown status
Freeman Hospital
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Newcastle upon TyneUnited KingdomUnknown status
Northampton General Hospital
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NorthamptonUnited KingdomUnknown status
Norfolk & Norwich Hospital
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NorwichUnited KingdomUnknown status
Nottingham City Hospital
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NottinghamUnited KingdomUnknown status
Churchill Hospital
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OxfordUnited KingdomUnknown status
Peterborough City Hospital
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PeterboroughUnited KingdomUnknown status
Derriford Hospital
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PlymouthUnited KingdomUnknown status
Glan Clwyd Hospital
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RhylUnited KingdomUnknown status
Queens Hospital
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RomfordUnited KingdomUnknown status
Weston Park Hospital
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SheffieldUnited KingdomUnknown status
Royal Stoke University Hospital
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Stoke-on-TrentUnited KingdomUnknown status
Sunderland Royal Hospital
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SunderlandUnited KingdomUnknown status
Kings Mill Hospital
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Sutton in AshfieldUnited KingdomUnknown status
Torbay District General Hospital
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TorquayUnited KingdomUnknown status
Royal Cornwall Hospital
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TruroUnited KingdomUnknown status
Southend University Hospital
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Westcliff-on-SeaUnited KingdomUnknown status
Worcestershire Royal Hospital
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WorcesterUnited KingdomUnknown status
Beaumont Hospital
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DublinIrelandUnknown status
St Luke's Hospital
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DublinIrelandUnknown status
St. James's Hospital
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DublinIrelandUnknown status
Beacon Hospital
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DublinIrelandUnknown status
Auckland City Hospital
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AucklandNew ZealandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.