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

April 16, 2021 updated by: Royal Marsden NHS Foundation Trust

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Surgery to remove the prostate gland is one of the ways of treating prostate cancer. Some patients receive radiotherapy after surgery if the cancer may not have been completely removed. Radiotherapy to the area where the prostate was can cause side effects, which can cause bowel and bladder symptoms as well as reducing sexual function.

Radiotherapy alone is also a standard treatment for prostate cancer. At the Royal Marsden Hospital and Institute of Cancer Research the investigators have designed and patented a device called ProSpare to improve the accuracy of radiotherapy. The device has already been developed and tested in over 80 patients having prostate radiotherapy and was well tolerated. Treatment accuracy was improved and the radiation dose to the rectum was reduced. Patients have given very valuable feedback and comments about ProSpare's design and use, which the investigators have incorporated in the final design. It is now important to test ProSpare in a multi-centre randomised controlled trial. The investigators aim to determine whether ProSpare will reduce the side effects reported by patients having radiotherapy after prostatectomy.

The ProSpare device is inserted by the patient into the rectum for each daily radiotherapy treatment. The disposable device stays in place for about 15 minutes each day. The curve in the device is designed to follow the shape of the rectum and it stays in the correct place by securely locating in the anal sphincter. ProSpare contains small "markers" - steel ball bearings - which can be "seen" on the standard scans taken before a radiotherapy treatment. Treatment is adjusted before each daily treatment to account for patient movement and radiotherapy set-up variation. As a result, treatment is more accurate than using the standard methods of radiotherapy localisation. This means the radiotherapy "safety margins" which are placed around the prostate bed can be reduced. The dose to the rectum and bladder as well as the structures that are associated with erectile function will be reduced. This may lead to an improvement in the side effects caused by radiotherapy.

Other ways to identify the treatment target area for such image guided radiotherapy (IGRT) includes the insertion of fiducial markers - usually in the form of gold seeds into the prostate or prostate bed. This has become standard practice in some radiotherapy centres for prostate radiotherapy but is technically complex for prostate bed radiotherapy and not routinely used. ProSpare has the additional advantage of being non-invasive and without the risk of infection associated with fiducial insertion.

Patients will be randomly selected to either have standard treatment or use ProSpare daily with adjusted set-up margins. During and after treatment, patients will be asked questions and given questionnaires to complete, asking about bowel, urinary and sexual function. The investigators will look at the results in each group and see if treatment with ProSpare has a benefit in improving the side effects from radiotherapy. If a benefit is seen, the aim will be for ProSpare guided radiotherapy to become part of the standard treatment for prostate bed radiotherapy nationally and internationally.

Study Type

Interventional

Enrollment (Anticipated)

245

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • Cambridge University Hospitals
        • Contact:
          • Dr Yvonne Rimmer
      • Guildford, United Kingdom, GU2 7XX
        • Recruiting
        • Royal Surrey County Hospital NHS Foundation Trust
        • Contact:
          • Dr Chee Goh
      • Ipswich, United Kingdom, IP4 5PD
        • Recruiting
        • East Suffolk and North Essex NHS Trust
        • Contact:
          • Dr Christopher Scrase
      • London, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospitals Nhs Foundation Trust
        • Contact:
          • Dr Reena Davda
      • London, United Kingdom, NW3 2QG
        • Not yet recruiting
        • Royal Free Hampstead NHS Trust
        • Contact:
          • Dr Sarah Needleman
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • The Royal Marsden NHSFT
        • Contact:
      • Middlesex, United Kingdom, HA6 2RN
        • Recruiting
        • East and North Hertfordshire NHS Trust, Mount Vernon Cancer Centre
        • Contact:
          • Prof Peter Hoskin
      • Norwich, United Kingdom, NR4 7UY
        • Recruiting
        • Norfolk and Norwich University Hospital NHSFT
        • Contact:
          • Dr Jenny Nobes
    • Somerset
      • Taunton, Somerset, United Kingdom, TA1 5DA
        • Not yet recruiting
        • Beacon Centre, Musgrove Park Hospital
        • Contact:
          • Dr Emma Gray
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • The Royal Marsden NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Dr Julia Murray

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion criteria:

  1. Patient has undergone radical prostatectomy
  2. Histologically confirmed prostatic cancer
  3. Patient due to receive post-operative prostate bed radiotherapy either in the adjuvant or salvage* setting
  4. WHO performance status 0-1 at randomization
  5. Age > 18 years
  6. Written informed consent
  7. Able to independently complete patient questionnaires

Exclusion Criteria:

  1. Lymph node or distant metastases from prostate cancer
  2. Prior pelvic radiotherapy
  3. Previous invasive cancer in the past 3 years, with the exception of non-melanoma skin cancer
  4. Symptomatic haemorrhoids or other anal conditions which affect adequate insertion and retention of the rectal obturator
  5. Planned chemotherapy within 2 months of completion of adjuvant or salvage radiotherapy
  6. Musculoskeletal conditions which limit flexibility or mobility and will make patient self insertion of ProSpare™ difficult
  7. Comorbid conditions likely to impact on advisability of prostate bed radiotherapy (e.g. inflammatory bowel disease, previous colorectal surgery, significant bladder instability or urinary incontinence)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ProSpare Arm
ProSpare (obturator) image guided IMRT (i.e. radiotherapy administered to patients with the ProSpare device inserted in the rectum)
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
Other Names:
  • Rectal obturator
NO_INTERVENTION: Non-ProSpare Arm
Standard of Care (non-obturator) image guided IMRT (i.e. radiotherapy administered to patients without the ProSpare device inserted in the rectum)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EPIC Bowel Scores for Bowel, Urinary and Sexual domains
Time Frame: Two years
Difference between groups in EPIC scores
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life measures
Time Frame: Two and Five years
Six Patient Reported Outcome Measure (PROM) questionnaires
Two and Five years
Dosimetric analysis
Time Frame: Two years
Analysis of dose/toxicity axis
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Collaborators

Institute of Cancer Research, United Kingdom

Investigators

  • Principal Investigator: Dr Julia Murray, Royal Marsden Hospital / Institute of Cancer Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 8, 2017

Primary Completion (ANTICIPATED)

December 31, 2024

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

November 25, 2016

First Submitted That Met QC Criteria

November 25, 2016

First Posted (ESTIMATE)

November 30, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 16, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR 4359

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We have not made a plan to share IPD at this stage but will finalise this following the first meeting of the Trial Management Group in Spring 2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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