Prostate CATransPRIDENCT06987045
Trans and Non-binary Prostate-Specific Antigen Reference Interval Determination Study
An observational study of Prostate CA, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Prostate CA
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Apr 2026to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Trans and non-binary people with a prostate (TNBPP) who are taking Gender-Affirming Hormone Therapy (GAHT) and/or have had bilateral orchidectomy.
Who may be able to join
- • 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
Who cannot join
- • 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Ambrose King Centre, Barts Health NHS Trust
London
James Hand, james.hand@nhs.net
Kyle Ring, kyle.ring@nhs.net
About this study
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.
Read more
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.
- Conditions
- Prostate CA
- Keywords
- Prostate Cancer, Transwomen, Non-binary, prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 40-49 year olds | Not described | |
| 50-59 year olds | Not described | |
| 60-79 year olds | Not described | |
| 70+ year olds | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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+).
Measured: 6months following end of enrolment
Secondary outcomes (1)
Prostate Cancer
The numbers of participants diagnosed with prostate cancer during the study.
Measured: 6months following end of enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start4 Apr 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987045
- Sponsor's protocol ID
- 336982
- Acronym
- TransPRIDE
- Status last verified
- Jun 2026
- First submitted
- 15 May 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans and Non-binary Prostate-Specific Antigen Reference Interval Determination Study
- ClinicalTrials.gov ID
- NCT06987045
- Acronym / sponsor ID
- TransPRIDE / 336982
- Conditions
- Prostate CA
- Keywords
- Prostate Cancer, Transwomen, Non-binary, prostate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 4 Apr 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 40-49 year olds | – | – |
| 50-59 year olds | – | – |
| 60-79 year olds | – | – |
| 70+ year olds | – | – |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Trans and non-binary people with a prostate (TNBPP) who are taking Gender-Affirming Hormone Therapy (GAHT) and/or have had bilateral orchidectomy.
Key inclusion criteria (8 listed)
- • Aged >40
Key exclusion criteria (13 listed)
- • History of prostate cancer (Prostate cancer) at any time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary endpoint is blood PSA concentration.
Time frame: 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+).
1 secondary outcome
Prostate Cancer
Time frame: 6months following end of enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate CA, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is blood PSA concentration. (time frame: 6months following end of enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.