CancerPhase 2POPSNCT02978014
A Trial Assessing Post-Operative Use of ProSpare, a Rectal Obturator in Prostate Cancer Radiotherapy
A Phase 2 study testing ProSpare in people with Cancer, run by Royal Marsden NHS Foundation Trust at 10 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cancer
- What is being tested?
- ProSpare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- 8 Feb 2017to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has undergone radical prostatectomy
- Histologically confirmed prostatic cancer
- Patient due to receive post-operative prostate bed radiotherapy either in the adjuvant or salvage* setting
- WHO performance status 0-1 at randomization
- Age > 18 years
- Written informed consent
- Able to independently complete patient questionnaires
Who cannot join
- Lymph node or distant metastases from prostate cancer
- Prior pelvic radiotherapy
- Previous invasive cancer in the past 3 years, with the exception of non-melanoma skin cancer
- Symptomatic haemorrhoids or other anal conditions which affect adequate insertion and retention of the rectal obturator
- Planned chemotherapy within 2 months of completion of adjuvant or salvage radiotherapy
- Musculoskeletal conditions which limit flexibility or mobility and will make patient self insertion of ProSpare™ difficult
- 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)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United Kingdom10 sites, 10 recruiting
- Recruiting
Cambridge University Hospitals
Cambridge, CB2 0QQ
Dr Yvonne Rimmer
- Recruiting
Royal Surrey County Hospital NHS Foundation Trust
Guildford, GU2 7XX
Dr Chee Goh
- Recruiting
East Suffolk and North Essex NHS Trust
Ipswich, IP4 5PD
Dr Christopher Scrase
- Recruiting
University College London Hospitals NHS Foundation Trust
London, NW1 2PG
Dr Reena Davda
- Not yet recruiting
Royal Free Hampstead NHS Trust
London, NW3 2QG
Dr Sarah Needleman
- Recruiting
The Royal Marsden NHSFT
London, SW3 6JJ
Sijy Pillai, POPS@rmh.nhs.uk
- Recruiting
East and North Hertfordshire NHS Trust, Mount Vernon Cancer Centre
Middlesex, HA6 2RN
Prof Peter Hoskin
- Recruiting
Norfolk and Norwich University Hospital NHSFT
Norwich, NR4 7UY
Dr Jenny Nobes
- Recruiting
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
Sijy Pillai, +44 208 915 6666, POPS@rmh.nhs.uk
Dr Julia Murray
- Not yet recruiting
Beacon Centre, Musgrove Park Hospital
Taunton, Somerset, TA1 5DA
Dr Emma Gray
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- ProSpare
- Keywords
- Prostate, Radiotherapy, Obturator, Toxicity, Bowel, Urinary, Sexual, PROM, EPIC
- Medical subject headings
- Neoplasms, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProSpareDevice
Also called Rectal obturator
A novel rectal obturator (ProSpare) acting as a non-invasive daily on-line image guided tool, a rectal spacer and a prostate bed stabiliser
| Study group | Role | What they receive |
|---|---|---|
| ProSpare Arm | Experimental | ProSpare (obturator) image guided IMRT (i.e. radiotherapy administered to patients with the ProSpare device inserted in the rectum) Receives: Device: ProSpare |
| Non-ProSpare Arm | No intervention | Standard of Care (non-obturator) image guided IMRT (i.e. radiotherapy administered to patients without the ProSpare device inserted in the rectum) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EPIC Bowel Scores for Bowel, Urinary and Sexual domains
Difference between groups in EPIC scores
Measured: Two years
Secondary outcomes (2)
Quality of Life measures
Six Patient Reported Outcome Measure (PROM) questionnaires
Measured: Two and Five years
Dosimetric analysis
Analysis of dose/toxicity axis
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study start8 Feb 2017
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Dr Julia Murray, Principal investigator, Royal Marsden Hospital / Institute of Cancer Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978014
- Sponsor's protocol ID
- CCR 4359
- Acronym
- POPS
- Status last verified
- Apr 2021
- First submitted
- 25 Nov 2016
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
Stewart S, Thomas K, Parmar J, Tree AC, Parker C, McNair H, Alexander S, Henderson J, Talbot J, Scrase C, Goh C, Davda R, Gray E, Hoskin P, Needleman S, Nobes J, Jayaprakash KT, Rimmer Y, Venkitaraman R, Wilkins A, Khoo V, Murray J, Dearnaley DP. Preliminary evaluation of ProSpare(R), a rectal obturator for prostate bed radiotherapy within the randomised multicentre POPS trial (NCT02978014). Front Oncol. 2026 Oct 12;16:1758462. doi: 10.3389/fonc.2026.1758462. eCollection 2026.
PubMed 42935520
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Phase II Trial Assessing Post-Operative Use of ProSpare, a Rectal Obturator in Prostate Cancer Radiotherapy
- ClinicalTrials.gov ID
- NCT02978014
- Acronym / sponsor ID
- POPS / CCR 4359
- Conditions
- Cancer
- Keywords
- Prostate, Radiotherapy, Obturator, Toxicity, Bowel, Urinary, Sexual, PROM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ProSpare Arm | Experimental | Device: ProSpareProSpare (obturator) image guided IMRT (i.e. radiotherapy administered to patients with the ProSpare device inserted in the rectum) |
| Non-ProSpare Arm | No intervention | –Standard of Care (non-obturator) image guided IMRT (i.e. radiotherapy administered to patients without the ProSpare device inserted in the rectum) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient has undergone radical prostatectomy
- Histologically confirmed prostatic cancer
- Patient due to receive post-operative prostate bed radiotherapy either in the adjuvant or salvage* setting
- WHO performance status 0-1 at randomization
- Age > 18 years
Key exclusion criteria (7 listed)
- Lymph node or distant metastases from prostate cancer
- Prior pelvic radiotherapy
- Previous invasive cancer in the past 3 years, with the exception of non-melanoma skin cancer
- Symptomatic haemorrhoids or other anal conditions which affect adequate insertion and retention of the rectal obturator
- Planned chemotherapy within 2 months of completion of adjuvant or salvage radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProSpareAlso: Rectal obturatorA novel rectal obturator (ProSpare) acting as a non-invasive daily on-line image guided tool, a rectal spacer and a prostate bed stabiliser | Device | ProSpare Arm |
Primary outcome
EPIC Bowel Scores for Bowel, Urinary and Sexual domains
Time frame: Two years
Difference between groups in EPIC scores
2 secondary outcomes
Quality of Life measures
Time frame: Two and Five years
Dosimetric analysis
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Derived from this study: PubMed 42935520Stewart S, Thomas K, Parmar J, Tree AC, Parker C, McNair H, Alexander S, Henderson J, Talbot J, Scrase C, Goh C, Davda R, Gray E, Hoskin P, Needleman S, Nobes J, Jayaprakash KT, Rimmer Y, Venkitaraman R, Wilkins A, Khoo V, Murray J, Dearnaley DP. Preliminary evaluation of ProSpare(R), a rectal obturator for prostate bed radiotherapy within the randomised multicentre POPS trial (NCT02978014). Front Oncol. 2026 Oct 12;16:1758462. doi: 10.3389/fonc.2026.1758462. eCollection 2026.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Julia Murray principal investigator
Royal Marsden Hospital / Institute of Cancer Research
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ProSpare in people with Cancer, run by Royal Marsden NHS Foundation Trust at 10 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sijy Pillai (+44 208 915 6666, POPS@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EPIC Bowel Scores for Bowel, Urinary and Sexual domains (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02978014, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.