Prostate Advances in Comparative Evidence (NCT01584258)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (32 items) and avoid the listed exclusions (12 items).
Location: Northeast Cancer Centre — Greater Sudbury, Ontario
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion criteria (all arms):
- 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) 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.
- Life expectancy \<5 years.
- Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts.
- 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.
- Participation in another concurrent treatment protocol for prostate cancer. Specific exclusion criteria for PACE-C:
- \>14 weeks of androgen deprivation therapy prior to randomisation
- Medical conditions likely to make ADT inadvisable (e.g. significant and ongoing cardiac issues).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (68 Sites)
- Northeast Cancer Centre — Greater Sudbury, Ontario
- Juravinski Cancer Centre — Hamilton, Ontario
- London Health Sciences Centre — London, Ontario
- Walker Family Cancer Centre — Niagara, Ontario
- Lakeridge Health — Oshawa, Ontario
- The Ottawa Hospital Cancer Centre — Ottawa, Ontario
- Odette Cancer Centre — Toronto, Ontario
- Hôpital Charles-LeMoyne — Montreal, Quebec
- Hôpital Maisonneuve Rosemont — Montreal, Quebec
- Beacon Hospital — Dublin,
- Beaumont Hospital — Dublin,
- St James's Hospital — Dublin,
- St. Luke's Hospital — Dublin,
- Auckland City Hospital — Auckland,
- Hinchingbrooke Hospital — Huntingdon, Cambridgeshire
- Colchester General Hospital — Colchester, Essex
- Churchill Hospital — Oxford, Oxfordshire
- Mount Vernon Cancer Centre — London, Surrey
- Velindre Cancer Centre — Cardiff, Wales
- University Hospital Coventry & Warwickshire NHS Trust — Coventry, West Midlands
- Royal United Hospital — Bath,
- Belfast City Hospital — Belfast,
- Queen Elizabeth Hospital — Birmingham,
- Pilgrim Hospital — Boston,
- Royal Sussex County Hospital — Brighton,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.