Trans and Non-binary Prostate-Specific Antigen Reference... | NCT06987045

Studies
Trans and Non-binary Prostate-Specific Antigen Reference Interval Determination Study

NCT06987045

Sponsor

Queen Mary University of London

Status

Recruiting

Last Update Posted

Jun 4, 2026Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Prostate CA

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 4, 2026Actual

Primary Completion Date

Mar 31, 2028Estimated

Completion Date

Mar 31, 2028Estimated

First Submitted Date

May 15, 2025

First Submission Date that Met QC Criteria

May 15, 2025

First Posted Date

May 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2026

Last Update Posted Date

Jun 4, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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+).	6months following end of enrolment

Secondary Outcomes

Measure	Description	Time Frame
Prostate Cancer	The numbers of participants diagnosed with prostate cancer during the study.	6months following end of enrolment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

100 Years

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Ambrose King Centre, Barts Health NHS Trust	Recruiting	London			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Label	Type	Description	Intervention Names
40-49 year olds
50-59 year olds
60-79 year olds
70+ year olds

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms