An observational study in Prostate Cancer Patients Treated by Radiotherapy, sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. Recruiting at 8 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Sheffield Teaching Hospitals NHS Foundation Trust · Observational
Recently, concerns have been raised by regulators that there is little data about the long-term safety of rectal hydrogel spacers for use in conjunction with radiotherapy treatment for prostate cancer. To address this, this study will collect data about the short-term side-effects and long-term safety of SpaceOAR and SpaceOAR Vue rectal hydrogel spacers in men who receive them in the UK and France. Men who have agreed to receive these spacers as part of their standard medical care will be asked to take part in the study whereby data about their treatment and health will be collected from their medical records and from members of the clinical team who deliver their treatment. Additionally, men will be asked to consent to completing questionnaires about their experiences of side effects from their treatment. Further information will be collected about their clinical characteristics before they receive a spacer, the physician-rated clinical performance of the spacer insertion procedure, their radiotherapy treatment plan and details of the other treatments they are also receiving which could influence the types and extent of side effects they experience. Data collection will span eight time points: pre-spacer insertion, spacer insertion, the start of radiotherapy, post-radiotherapy follow-up, 6-month follow-up, 12-month follow-up, 24-month follow-up \& 36-month follow-ups. Outside of these timepoints treatment-related adverse event data will be concurrently reported and collated. Participants' treatments will not be changed as a result of their participation in this study. Data from this study will be used to summarise the characteristics of this study population, physicians' perceptions of the spacer implantation procedure, the radiotherapy treatments plans made, and the types, extent and timing of treatment-related adverse events and side effects.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 320 is above the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Sheffield Teaching Hospitals NHS Foundation Trust is the lead sponsor of 214 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Men with prostate cancer having radiotherapy with curative intent and having a SpaceOAR as part of standard care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who agrees to participate and has been deemed by their medical team to have capacity to provide;
Exclusion Criteria:
- Patients lacking the capacity to provide;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receiving prostate cancer care in the UK and France
Device: SpaceOAR / SpaceOAR Vue hydrogel system
Space OAR/SpaceOAR Vue Systems are biodegradable medical devices that are implanted between the prostate and rectum to temporarily move part of the rectal wall away from the prostate during radiation therapy for prostate cancer.
Short-term safety of SpaceOAR/SpaceOAR Vue systems.
Proportion of subjects experiencing any of the following within 30 days post-implantation of SpaceOAR/SpaceOAR Vue hydrogel, as adjudicated by the Independent Clinical Events Committee: * Symptoms (PROMs): Measured using validated patient-reported outcome questionnaires. A subject is counted if any PROM score exceeds the predefined threshold for clinically significant symptoms. * Adverse Events (CTCAE v5.0): Measured as the occurrence of any adverse event graded per CTCAE v5.0. * Abnormal Imaging (MRI/CT): A subject is counted if any abnormality is confirmed by radiology review. \* The study instruments in the French population with include Grade 1 and above events (CTCAEv5.0) * Unit of Measure: Percentage of subjects (%) * Each category will be reported separately.
Time frame: 30 days post-implantation
Long-Term Safety of SpaceOAR/SpaceOAR Vue Systems
Proportion of subjects experiencing Grade ≥2 gastrointestinal or anorectal toxicity (per CTCAE v5.0) within 3 years after completion of radiation therapy. \* The study instruments in the French population with include Grade 1 and above events (CTCAEv5.0) • Unit of Measure: Percentage of subjects (%)
Time frame: Up to 3 years post-radiation therapy
Proportion of subjects with Grade 2* & above; gastrointestinal, anorectal, genitourinary toxicity at 12, 24 & 36 months.
Proportion of subjects experiencing Grade ≥2 toxicity (as per CTCAE v5.0) in gastrointestinal, anorectal, or genitourinary systems at 12, 24, and 36 months post-radiation therapy. • Unit of Measure: Percentage of subjects (%) Note: For French population, Grade ≥1 events will also be included.
Time frame: 12, 24, and 36 months post-radiation therapy
Physician rating of SpaceOAR/SpaceOAR Vue of Placement Difficulty
Rated on a Likert scale (1 = very difficult, 5 = very easy) immediately after procedure. Unit of Measure: Mean Likert score
Time frame: At time of implantation
Patient Perception of SpaceOAR/SpaceOAR Vue Procedure Compared to Prostate Biopsy
Measured using a structured questionnaire comparing perceived discomfort and acceptability relative to prostate biopsy. • Unit of Measure: Percentage of subjects reporting "less discomfort," "similar," or "more discomfort
Time frame: Within 30 days post-procedure
Overall Mortality and Cause of Death
Number and proportion of subjects who die during the study period, with cause adjudicated by Independent Clinical Events Committee. • Unit of Measure: Number of deaths and percentage (%)
Time frame: Up to 36 months
Selection Criteria for SpaceOAR/SpaceOAR Vue Placement
Analysis of baseline clinical and demographic factors associated with successful placement. • Unit of Measure: Descriptive statistics (frequency, percentage)
Time frame: At enrolment
Time to Onset of Grade ≥2 Gastrointestinal, Anorectal, and Genitourinary Toxicity
Measured as time (in months) from radiation therapy completion to first occurrence of Grade ≥2 toxicity (per CTCAE v5.0). • Unit of Measure: Median time to onset (months)
Time frame: Up to 36 months
Impact of treatment on bowel function, urinary function, sexual function and overall quality of life as measured by EPIC-26
The EPIC-26 questionnaire is a preeminent tool extensively characterised to measure health-related quality of life in men with localised prostate cancer across specific domains * Urinary function * Bowel function * Sexual function * Effects of hormone treatment Scores range from 0-100, with higher scores indicating better function or quality of life. Unit of Measure: Mean score change from baseline (points)
Time frame: Baseline, 12, 24 and 36 months
Impact of treatment on bowel function, urinary function, sexual function and overall quality of life as measured by IPSS
International Prostate Symptom Score (IPSS). IPSS assesses urinary voiding symptoms and bother. For voiding symptoms, a score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms, and the urinary bother scale ranges from 0 (Delighted) to 6 (Terrible). Unit of Measure: Mean score change from baseline (points)
Time frame: Baseline, 12, 24 and 36 months
Impact of treatment on bowel function as measured by Vaizey incontinence score
The Vaizey Incontinence Score is a general-purpose scale for faecal incontinence that ranges from 0 to 24 with higher scores representing worst incontinence. Unit of Measure: Mean score change from baseline (points)
Time frame: Baseline, 12, 24 and 36 months
Impact of concomitant prostate cancer treatment usually Androgen Deprivation Therapy (ADT) on the lives of participants as measured by The Symptom Index
The Symptom Index is an un-validated questionnaire which has been developed to capture the impact of the side effects of concomitant prostate cancer treatment (usually ADT} on the lives of participants. The questions capture the quality of life using the scale: 0 - 4, with higher scores indicating worse symptoms or quality of life. Unit of measure: Mean score change from baseline (points)
Time frame: Baseline, 12, 24, 36 months
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Feb 2030, 50 months after the start.
Of 541 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 162. This study's planned 50 months is below that.
Counting every sponsor, half of 650 studies reached it within 60 months; a quarter within 29 and three quarters within 141.
How these figures are worked out, and which studies are left out of them.
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Sheffield Teaching Hospitals NHS Foundation Trust →