Trans and Non-binary Prostate-Specific Antigen Reference Interval Determination Study
ConditionProstate CA
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-100
SponsorQueen Mary University of London
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
• Aged >40
Transgender or non-binary (identify with a gender other than the one assigned at birth)
With a prostate
Taking oestradiol for at least the last 3 months
Disqualifiers
• 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
Trial population
Trans and non-binary people with a prostate (TNBPP) who are taking Gender-Affirming Hormone Therapy (GAHT) and/or have had bilateral orchidectomy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 4 trial groupsGroup A: 40-49 year olds
Group B: 50-59 year olds
Group C: 60-79 year olds
Group D: 70+ year olds
Trial outcomes
Primary outcomes
1
The primary endpoint is blood PSA concentration.
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+).
Time frame
6months following end of enrolmentSecondary outcomes
1
Prostate Cancer
The numbers of participants diagnosed with prostate cancer during the study.
Time frame
6months following end of enrolmentSponsors and contacts
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Source ClinicalTrials.gov