OASIS: SpaceOAR PoSt - Market Registry Study: Assessing the Safety & Acceptability of SpaceOAR Use With Prostate Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 9
- 主要终点
- Short-term safety of SpaceOAR/SpaceOAR Vue systems.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •- 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)
研究组 & 干预措施
All participants
Participants receiving prostate cancer care in the UK and France
干预措施: SpaceOAR / SpaceOAR Vue hydrogel system (Device)
结局指标
主要结局
Short-term safety of SpaceOAR/SpaceOAR Vue systems.
时间窗: 30 days post-implantation
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.
Long-Term Safety of SpaceOAR/SpaceOAR Vue Systems
时间窗: Up to 3 years post-radiation therapy
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 (%)
次要结局
- Proportion of subjects with Grade 2* & above; gastrointestinal, anorectal, genitourinary toxicity at 12, 24 & 36 months.(12, 24, and 36 months post-radiation therapy)
- Physician rating of SpaceOAR/SpaceOAR Vue of Placement Difficulty(At time of implantation)
- Patient Perception of SpaceOAR/SpaceOAR Vue Procedure Compared to Prostate Biopsy(Within 30 days post-procedure)
- Overall Mortality and Cause of Death(Up to 36 months)
- Selection Criteria for SpaceOAR/SpaceOAR Vue Placement(At enrolment)
- Time to Onset of Grade ≥2 Gastrointestinal, Anorectal, and Genitourinary Toxicity(Up to 36 months)
- Impact of treatment on bowel function, urinary function, sexual function and overall quality of life as measured by EPIC-26(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(Baseline, 12, 24 and 36 months)
- Impact of treatment on bowel function as measured by Vaizey incontinence score(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(Baseline, 12, 24, 36 months)