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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,205
Radical prostatectomy: performed open, laparoscopically or using a robotically assisted laparoscopic approach.
Conventional fractionation delivered to a dose of: (PACE-B) 78 Gy in 39 fractions or 62 Gy in 20 fractions; (PACE-C) 60 Gy in 20 fractions
Prostate SBRT delivered to a dose of 36.25 Gy in 5 fractions.
Northeast Cancer Centre
Greater Sudbury, Ontario, Canada
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
PACE-B and PACE-C: Freedom from biochemical or clinical failure
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 metastases
Time frame: 5 years from randomisation (primary timepoint)
PACE-A: Co-primary patient reported outcomes of urinary incontinence and bowel bother
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.
Time frame: 2 years from treatment (primary timepoint)
All arms: Clinician reported acute toxicity
CTCAE and RTOG (SBRT and conventional RT patients) or Clavien scale (surgical patients).
Time frame: 10 years
All arms: Clinician reported late toxicity
CTCAE and RTOG (SBRT and conventional RT patients only).
Time frame: 10 years
All arms: Patient reported acute and late bowel, bladder and erectile dysfunction symptoms.
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.
Time frame: 10 years
All arms: Disease-specific and overall survival
Disease-specific and overall survival
Time frame: 10 years
All arms: Progression-free survival
Radiographic, clinical or biochemical evidence of local or distant failure
Time frame: 10 years
PACE-A and PACE-B: Commencement of androgen deprivation therapy; PACE-C: Re-commencement of androgen deprivation therapy
LHRH analogues, anti-androgens, orchidectomy
Time frame: 10 years
PACE-A: Freedom from biochemical or clinical failure
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 metastases
Time frame: 5 years from randomisation (primary timepoint)
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Ottawa, Ontario, Canada
Odette Cancer Centre
Toronto, Ontario, Canada
Hôpital Charles-LeMoyne
Montreal, Quebec, Canada
Hôpital Maisonneuve Rosemont
Montreal, Quebec, Canada
Beacon Hospital
Dublin, Ireland
...and 58 more locations