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

NCT02978014 | Unknown Phase 2 DMC

• 1 other identifier: CCR 4359
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 10

Brief 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

Cancer

Keywords

Prostate; Radiotherapy; Obturator; Toxicity; Bowel; Urinary; Sexual; PROM; EPIC

Outcome Measures

Primary Outcomes (1)

• EPIC Bowel Scores for Bowel, Urinary and Sexual domains

  Difference between groups in EPIC scores

  Two years

Secondary Outcomes (2)

• Quality of Life measures

  Two and Five years

• Dosimetric analysis

  Two years

Study Arms (2)

ProSpare Arm

EXPERIMENTAL

ProSpare (obturator) image guided IMRT (i.e. radiotherapy administered to patients with the ProSpare device inserted in the rectum)

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)

Interventions

ProSpare DEVICE

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

Also known as: Rectal obturator

ProSpare Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Institute of Cancer Research, United Kingdom: collaborator

Study Sites (10)

Beacon Centre, Musgrove Park Hospital

Taunton, Somerset, TA1 5DA, United Kingdom

NOT YET RECRUITING

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

Cambridge University Hospitals

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

Royal Surrey County Hospital NHS Foundation Trust

Guildford, GU2 7XX, United Kingdom

RECRUITING

East Suffolk and North Essex NHS Trust

Ipswich, IP4 5PD, United Kingdom

RECRUITING

University College London Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

RECRUITING

Royal Free Hampstead NHS Trust

London, NW3 2QG, United Kingdom

NOT YET RECRUITING

The Royal Marsden NHSFT

London, SW3 6JJ, United Kingdom

RECRUITING

East and North Hertfordshire NHS Trust, Mount Vernon Cancer Centre

Middlesex, HA6 2RN, United Kingdom

RECRUITING

Norfolk and Norwich University Hospital NHSFT

Norwich, NR4 7UY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neoplasms; Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Dr Julia Murray

  Royal Marsden Hospital / Institute of Cancer Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sijy Pillai

CONTACT

+44 208 915 6666; POPS@rmh.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2016
• First Posted: November 30, 2016
• Study Start: February 8, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (10)