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Prostate Advances in Comparative Evidence

NCT01584258 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2205

Last updated 2024-01-19

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

Prostatectomy

Radical prostatectomy: performed open, laparoscopically or using a robotically assisted laparoscopic approach.

RADIATION

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

RADIATION

Prostate SBRT

Prostate SBRT delivered to a dose of 36.25 Gy in 5 fractions.

Sponsors & Collaborators

  • The Institute of Cancer Research, Sutton, Surrey, UK

    collaborator UNKNOWN

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Nicholas van As, MD · Royal Marsden NHS Foundation Trust, London, United Kingdom

  • Peter Ostler, MD · Mount Vernon Cancer Centre, United Kingdom

  • Alison Tree, MD · Royal Marsden NHS Foundation Trust, London, United Kingdom

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-07
Primary Completion
2025-12-31
Completion
2027-12-31

Countries

  • Canada
  • Ireland
  • New Zealand
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01584258 on ClinicalTrials.gov