Prostate cancer Cancer
Conditions
Interventions
DESIGN
This observational multi-centre, multi-national study uses a prospective cohort design. This design was chosen because the study is intended to act as an enhanced form of post-marketing surveil
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Male
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. All patients with a clinical diagnosis of prostate cancer planned to undergo treatment with curative intent at selected sites in the UK subject to SpaceOAR being used as usual standard of care 2. Age >=18 years old 3. Capacity to provide verbal, informed consent for participation over the telephone
Exclusion criteria
Exclusion criteria: Patients lacking the capacity to provide informed consent, including those unable to understand verbal explanation or written information in English, or who have specific communication needs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of subjects experiencing symptoms (PROMs), adverse events (CTCAEv5.0) or abnormal imaging (MR/CT) related to the procedure of SpaceOAR/SpaceOAR Vue System hydrogel within 30 days of implantation (as adjudicated by the independent Clinical Events Committee) 2. The proportion of subjects with Grade =2* gastro-intestinal/ano-rectal (GI) toxicity (CTCAE v5.0) within 3 years of receiving radiation therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of subjects with relevant Grade =2* gastro-intestinal/ anorectal (GI) toxicity at 12, 24 and 36 months 2. Proportion of subjects with relevant Grade =2* genitourinary (GU) toxicity at 12, 24 and 36 months 3. Impact of treatment on bowel function as measured on the bowel domain of EPIC26 up to 3 years post radiation therapy (PROMs) 4. Impact of treatment on urinary, sexual, and overall Quality of Life (QoL) (EPIC26) assessments up to 3 years post radiation therapy (PROMs) 5. Physician rating of SpaceOAR/SpaceOAR Vue placement on a Likert scale of 1 (very difficult) to 5 (very easy) at time of spacer insertion 6. Patient-reported perception of procedure relative to biopsy procedure at time of spacer insertion 7. Overall mortality and causes of mortality at 3 years 8. Selection criteria for placement of SpaceOAR/SpaceOAR Vue system 9. Onset time of Grade = 2* gastro-intestinal/ano-rectal toxicity 10. Onset time of Grade = 2* genito-urinary toxicity using EPIC-26 and IPSS | — |
Countries
England, United Kingdom
Outcome results
None listed