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
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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