| NCT ID | NCT07300631 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust |
| Condition | Prostate Cancer Patients Treated by Radiotherapy |
| Study Type | OBSERVATIONAL |
| Enrollment | 320 participants |
| Start Date | 2025-12-31 |
| Primary Completion | 2030-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 320 participants in total. It began in 2025-12-31 with a primary completion date of 2030-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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) Exclusion Criteria: \- Patients lacking the capacity to provide; * 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)
Contact & Investigator
Derek Rosario
STUDY CHAIR
Sheffield Teaching Hospitals NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT07300631 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer Patients Treated by Radiotherapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07300631 currently recruiting?
Yes, NCT07300631 is actively recruiting participants. Visit ClinicalTrials.gov or contact Sheffield Teaching Hospitals NHS Foundation Trust to inquire about joining.
Where is the NCT07300631 trial being conducted?
This trial is being conducted at Toulouse, France, Valenciennes, France, Derby, United Kingdom, Liverpool, United Kingdom and 3 additional locations.
Who is sponsoring the NCT07300631 clinical trial?
NCT07300631 is sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. The principal investigator is Derek Rosario at Sheffield Teaching Hospitals NHS Foundation Trust. The trial plans to enroll 320 participants.
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