SpaceOAR Post-Market Registry Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorSheffield Teaching Hospitals NHS Foundation Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients with a clinical diagnosis of prostate cancer planned to undergo treatment with curative intent at selected sites in the UK & France subject to a SpaceOAR being used as usual care.
Aged 18 years old or above.
Patients who agrees to participate and has been deemed by their medical team to have capacity to provide;
verbal, informed consent over telephone as documented on the study informed consent form by the Researchers (UK only)
Disqualifiers
informed consent as documented on the study informed consent form by the - Researchers (UK only)
written, informed consent by signature of the study informed consent form (France only)
Trial population
Men with prostate cancer having radiotherapy with curative intent and having a SpaceOAR as part of standard care.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
SpaceOAR / SpaceOAR Vue hydrogel system
DeviceSpace 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.
Treatment groups
320 Participants
are divided into 1 treatment groupGroup A: All participants1 intervention
Trial outcomes
Primary outcomes
1
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-implantation2
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 therapySecondary outcomes
1
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 therapy2
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 implantation3
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-procedure4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sheffield Teaching Hospitals NHS Foundation Trust
Lead sponsor
Clinique Pasteur Toulouse
Collaborator
Sheffield Hallam University
Collaborator
Source ClinicalTrials.gov