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Clinical Trials in Ireland / NCT01584258
Active, not recruiting Phase 3

Prostate Advances in Comparative Evidence

NCT01584258 · tracked via the Priya Life Science Ireland tracker
Sponsor
Royal Marsden NHS Foundation Trust
Phase
Phase 3
Started
2012-08-07
Last updated
2024-01-19

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

ProstatectomyConventionally Fractionated Prostate RadiotherapyProstate SBRT

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)

Trial sites (68)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT01584258 on ClinicalTrials.gov ↗ ← All trials in Ireland