Prostatectomy: Radical prostatectomy: performed open, laparoscopically or using a robotically assisted laparoscopic approach.
Conventionally Fractionated Prostate Radiotherapy: 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: Prostate SBRT delivered to a dose of 36.25 Gy in 5 fractions.
Study 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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
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).
Primary outcome measure(s)
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 metastases
PACE-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.
Trial sites (68)
Facility
City
Region
Status
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
Ireland
Beaumont Hospital
Dublin
Ireland
St James's Hospital
Dublin
Ireland
St. Luke's Hospital
Dublin
Ireland
Auckland City Hospital
Auckland
New Zealand
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
United Kingdom
Belfast City Hospital
Belfast
United Kingdom
Queen Elizabeth Hospital
Birmingham
United Kingdom
Pilgrim Hospital
Boston
United Kingdom
Royal Sussex County Hospital
Brighton
United Kingdom
Bristol Haematology and Oncology Centre
Bristol
United Kingdom
West Suffolk Hospital
Bury
United Kingdom
Addenbrooke's Hospital
Cambridge
United Kingdom
Queen Elizabeth Hospital
Cambridge
United Kingdom
Kent and Canterbury Hospital
Canterbury
United Kingdom
Velindre Hospital
Cardiff
United Kingdom
Cheltenham General Hospital
Cheltenham
United Kingdom
Royal Derby Hospital
Derby
United Kingdom
Western General
Edinburgh
United Kingdom
Royal Devon and Exeter Hospital
Exeter
United Kingdom
The Beatson
Glasgow
United Kingdom
Royal Surrey County Hospital
Guildford
United Kingdom
Ipswich Hospital
Ipswich
United Kingdom
Leicester Royal Infirmary
Leicester
United Kingdom
Lincoln County Hospital
Lincoln
United Kingdom
+ 28 more sites — see the full list on the official registry below.
More Royal Marsden NHS Foundation Trust trials in Ireland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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