SpaceOAR Post-Market Registry Study (OASIS)

NHS Foundation Trust

Status: Enrolling

Conditions: Prostate Cancer Patients Treated by Radiotherapy

Treatments: Device: SpaceOAR / SpaceOAR Vue hydrogel system

Study type: Observational

Funder types: Other

Identifiers

NCT07300631

STH22555

IRAS Project ID: 341038 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

320 participants in 1 patient group

All participants

Description:

Participants receiving prostate cancer care in the UK and France

Treatment:

Device: SpaceOAR / SpaceOAR Vue hydrogel system