Trans and Non-binary Prostate-Specific Antigen Reference Interval Determination Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The primary endpoint is blood PSA concentration.
研究概览
简要总结
The prostate specific antigen (PSA) blood test can help diagnose prostate problems, including cancer.
The prostate is an organ in the pelvis. It is found in cisgender men, transgender (trans) women and some non-binary people.
Anyone with a prostate can get prostate cancer. The prostate remains after genital (lower) surgery. The hormones and surgeries that trans women and non-binary people might have can lower the PSA. We do not have good data on the normal PSA levels are for this group
TransPRIDE is a research study that will help us find the normal levels of PSA in trans women and non-binary people with prostates.
Researchers will ask 500 trans women and non-binary people with prostates to take part. They will need to be aged 40 or over. They will need to be on hormones or have had lower surgery. They will be called after 6 months to recheck their health. If a person has a high PSA, they may be sent for more tests.
Knowing the normal PSA level for trans women and non-binary people will help doctors to find and treat their prostate cancer more quickly.
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
- 40 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Aged >40
- •Transgender or non-binary (identify with a gender other than the one assigned at birth)
- •With a prostate
- •Fulfills at least one of the following 3 criteria with regards to gender-affirming medical care:
- •Taking oestradiol for at least the last 3 months
- •Taking anti-androgens for at least the last 3 months
- •Ever had bilateral orchidectomy
- •Eligible for National Health Service (NHS) treatment
排除标准
- •• History of prostate cancer (Prostate cancer) at any time
- •History of prostate surgery at any time
- •History of prostate radiotherapy at any time
- •History of benign prostatic hypertrophy (enlarged prostate) at any time
- •Vaginoplasty within 12 months
- •Orchidectomy or vulvoplasty within three months
- •Sexually Transmitted Infection (STI) within 6 weeks of blood sample
- •Active urinary infection or within 6 weeks of blood sample
- •Prostatitis within 6 weeks of blood sample
- •Urological intervention (e.g. prostate biopsy) within 6 weeks of blood sample
- •Unwilling to give consent
- •Lacking capacity to give consent
- •In the secure estate
研究组 & 干预措施
40-49 year olds
50-59 year olds
60-79 year olds
70+ year olds
结局指标
主要结局
The primary endpoint is blood PSA concentration.
时间窗: 6months following end of enrolment
The 95th percentile will be used to define the upper reference value of PSA values in healthy individuals; this will be estimated separately for each age group (i.e. 40-49, 50-59, 60-79, 70+).
次要结局
- Prostate Cancer(6months following end of enrolment)