Prostate Advances in Comparative Evidence
- Conditions
- Prostate Cancer
- Registration Number
- NCT01584258
- Lead Sponsor
- Royal Marsden NHS Foundation Trust
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 2205
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method PACE-B and PACE-C: Freedom from biochemical or clinical failure 5 years from randomisation (primary timepoint) Biochemical progression is defined as: Phoenix definition
Clinical progression is defined as: commencement (PACE-B) or re-commencement (PACE-C) of androgen deprivation therapy, local recurrence, nodal recurrence and distant metastasesPACE-A: Co-primary patient reported outcomes of urinary incontinence and bowel bother 2 years from treatment (primary timepoint) Urinary incontinence assessed by the number of absorbent pads required per day to control leakage measured by The Expanded Prostate Cancer Index (EPIC) questionnaire.
Bowel bother assessed by summary score from the EPIC questionnaire.
- Secondary Outcome Measures
Name Time Method All arms: Clinician reported acute toxicity 10 years CTCAE and RTOG (SBRT and conventional RT patients) or Clavien scale (surgical patients).
All arms: Progression-free survival 10 years Radiographic, clinical or biochemical evidence of local or distant failure
All arms: Disease-specific and overall survival 10 years Disease-specific and overall survival
All arms: Patient reported acute and late bowel, bladder and erectile dysfunction symptoms. 10 years Assessed using International Index of Erectile Function-5 (IIEF-5), International Prostate Symptom Score (IPSS), Vaizey score, and Expanded Prostate Index Composite-26 (EPIC-26) instruments.
PACE-A and PACE-B: Commencement of androgen deprivation therapy; PACE-C: Re-commencement of androgen deprivation therapy 10 years LHRH analogues, anti-androgens, orchidectomy
PACE-A: Freedom from biochemical or clinical failure 5 years from randomisation (primary timepoint) Biochemical progression is defined as: Phoenix definition (SBRT arm) or \>0.2ng/ml (surgical arm)
Clinical progression is defined as: commencement of androgen deprivation therapy, local recurrence, nodal recurrence and distant metastasesAll arms: Clinician reported late toxicity 10 years CTCAE and RTOG (SBRT and conventional RT patients only).
Trial Locations
- Locations (67)
Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Walker Family Cancer Centre
🇨🇦Niagara, Ontario, Canada
Lakeridge Health
🇨🇦Oshawa, Ontario, Canada
The Ottawa Hospital Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Northeast Cancer Centre
🇨🇦Sudbury, Ontario, Canada
Odette Cancer Centre
🇨🇦Toronto, Ontario, Canada
Hôpital Maisonneuve Rosemont
🇨🇦Montreal, Quebec, Canada
Hôpital Charles-LeMoyne
🇨🇦Montréal, Quebec, Canada
Beacon Hospital
🇮🇪Dublin, Ireland
Scroll for more (57 remaining)Juravinski Cancer Centre🇨🇦Hamilton, Ontario, Canada