SpaceOAR Post-Market Registry Study

Official title

OASIS: SpaceOAR PoSt - Market Registry Study: Assessing the Safety & Acceptability of SpaceOAR Use With Prostate Radiotherapy

Overview

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.

Interventions

• 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.

Primary outcome measures

• Short-term safety of SpaceOAR/SpaceOAR Vue systems. [Time frame: 30 days post-implantation]
• Long-Term Safety of SpaceOAR/SpaceOAR Vue Systems [Time frame: Up to 3 years post-radiation therapy]

Secondary outcome measures (10)

• Proportion of subjects with Grade 2* & above; gastrointestinal, anorectal, genitourinary toxicity at 12, 24 & 36 months. [Time frame: 12, 24, and 36 months post-radiation therapy]
• Physician rating of SpaceOAR/SpaceOAR Vue of Placement Difficulty [Time frame: At time of implantation]
• Patient Perception of SpaceOAR/SpaceOAR Vue Procedure Compared to Prostate Biopsy [Time frame: Within 30 days post-procedure]
• Overall Mortality and Cause of Death [Time frame: Up to 36 months]
• Selection Criteria for SpaceOAR/SpaceOAR Vue Placement [Time frame: At enrolment]
• Time to Onset of Grade ≥2 Gastrointestinal, Anorectal, and Genitourinary Toxicity [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 [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 [Time frame: Baseline, 12, 24 and 36 months]
• Impact of treatment on bowel function as measured by Vaizey incontinence score [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 [Time frame: Baseline, 12, 24, 36 months]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United Kingdom · 5 centers

• University Hospitals of Derby & Burton NHS Foundation Trust — Derby
• The Clatterbridge Cancer Centre NHS Foundation Trust — Liverpool
• Royal Free London — London
• Maidstone & Tunbridge Wells NHS Trust — Maidstone
• Norfolk & Norwich University Hospital NHS Foundation Trust — Norwich

France · 3 centers

• CHU de Brest, Boulevard de Tanguy Prigent — Brest
• Clinique Pasteur — Toulouse
• Centre de cancérologie Les Dentellières — Valenciennes

Identifiers

NCT: NCT07300631 · STH22555 · IRAS Project ID: 341038

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗