A Trial Assessing Post-Operative Use of ProSpare, a Rectal Obturator in Prostate Cancer Radiotherapy

NCT02978014 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2021-04-19

No results posted yet for this study

Summary

A two-arm randomised controlled trial in patients receiving post-prostatectomy radiotherapy in the adjuvant or salvage setting, with patients randomised to receive daily ProSpare (obturator) guided IMRT or Centre standard (non-obturator) guided IMRT.

Conditions

Interventions

DEVICE

ProSpare

A novel rectal obturator (ProSpare) acting as a non-invasive daily on-line image guided tool, a rectal spacer and a prostate bed stabiliser

Sponsors & Collaborators

  • Institute of Cancer Research, United Kingdom

    collaborator OTHER
  • Royal Marsden NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Dr Julia Murray · Royal Marsden Hospital / Institute of Cancer Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-08
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United Kingdom

Study Locations

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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 NCT02978014 on ClinicalTrials.gov