ClinicaliQ Trial Snapshot
- SpaceOAR Post-Market Registry Study — Recruiting • Oncology • NCT07300631.
- What is being tested: Long-term safety profile of rectal hydrogel spacers (SpaceOAR) used during radiotherapy for prostate cancer, addressing regulatory concerns about limited post-market safety data.
- Patient eligibility overview: Men undergoing radiotherapy for prostate cancer who are suitable candidates for hydrogel spacer placement to create separation between the rectum and prostate during treatment.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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…
Eligibility Snapshot
- : * 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) * written, informed consent by signature of the study informed consent form (France only) * Patient covered by social security scheme (France only)
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.