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Blood test could revolutionize prostate cancer treatment choices

NCT ID NCT04067713

Knowledge-focused Sponsor: University College, London Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study, called PARADIGM, is not testing a new drug. Instead, it looks at whether analyzing DNA from a blood sample can tell doctors which standard treatment—like hormone therapy or chemotherapy—will work best for a patient with metastatic prostate cancer. Researchers will take extra blood samples from 192 participants during their normal care and measure markers like PSA and tumor DNA. The goal is to create a test that personalizes treatment, saving time and avoiding side effects from drugs that won't help.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this blood test could help doctors choose the most effective existing treatment for each patient with metastatic prostate cancer, improving outcomes and avoiding ineffective therapies.
What could go wrong
This is an observational study, not a treatment trial. The blood test may not prove accurate enough to guide decisions, and results may take years to confirm.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

192 people

The number who actually took part.

Started

Sep 2019

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Newly diagnosed metastatic prostate cancer patients starting long term therapy with either Androgen Receptor Signalling Inhibitor (ARSI) drugs (PARADIGM A) or Docetaxel (PARADIGM D) with androgen deprivation therapy (ADT). This is a UK based trial recruiting from approximately 20 sites over 36 months with a maximum follow up for 10 years. Patients will be screened at Multi disciplinary teams, and patient clinic appointments and those who fulfill eligibility criteria will be offered to take part. They will be given the patient information sheet (PIS) to take away and read and discuss with family and friends. They will be given the opportunity to ask questions before they consent. If the patient wishes, consent can happen on the same day as the PIS was given.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Able and willing to provide written informed consent 2. Aged 18 or over 3. Polymetastatic disease defined as one of the following: i. ≥5 bone metastases ii. ≥1 unequivocal visceral metastases 4. Eastern Cooperative Oncology Group (ECOG) Performance status 0 to 2 5. No medical contra-indications to an Androgen receptor signalling inhibitor (ARSI) or docetaxel (with or without prednisolone). 6. Patients should be either of the following: i. Planned to start long-term Luteinizing hormone Releasing Hormone (LHRH) suppression, or ii. Have started long-term LHRH antagonist within the last 14 weeks, or iii. Have started LHRH agonist within the last 16 weeks. When antiandrogens (eg bicalutamide) are used in combination with an LHRH agonist to prevent flare, patients have to have started within 18 weeks of starting antiandrogens.. 7. Patients should be planned for addition of docetaxel (PARADIGM-D) or ARSI (PARADIGM-A) within 14 weeks after start of LHRH antagonist ( 16 weeks if LHRH agonist is started without anti-androgen) or 18 weeks from start of anti-androgen with a target of 6 cycles or continuation until progression respectively. 8. No concomitant medical conditions likely to reduce life expectancy. 9. Patient agrees to be followed up in the recruiting centre and to having sequential plasma samples collected as per the study protocol. Exclusion Criteria: 1 Concurrent or planned for (i.e. prior to development of castration resistance), treatment with oestrogen, radiotherapy or surgery to the primary tumour. (N.B Patients may also be eligible if randomised to any of the following experimental drugs; PARPi, PD-1/PD-L1 , AKTi, PSMA-lutetium, if given in combination with SOC(i.e. ADT + docetaxel or ARSI) treatment in an open-label clinical trial, or to the placebo arm in an open-label clinical trial following discussion and approval of the CI/delegate. Patients can participate in other observational studies). 2\. Prior systemic therapy for prostate cancer other than for LHRHa +/- anti-androgen (started within the time limits defined in inclusion criterion 7). 3\. Metastatic brain disease or leptomeningeal disease. 4\. Any surgery planned prior to Cycle 4 Day 1 (C4 D1) 5\. Other current malignancy or malignancy diagnosed or relapsed within the past 5 years (other than non-melanomatous skin cancer, stage 0 melanoma in situ and non-muscle invasive bladder cancer). 6\. Patients who consent to the whole-body magnetic resonance imaging (WBMRI) translational sub-study should have no contraindications to MRI as per local guidelines.

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic prostate cancer

Contacts and locations

Locations

  • Aberdeen Royal Infirmary

    Aberdeen, AB15 6RE, United Kingdom

  • Barts Health NHS Trust, Royal London Hospital

    London, E1 1FR, United Kingdom

  • Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

    Doncaster, DN2 5LT, United Kingdom

  • Guy's and St Thomas's NHS Foundation Trust

    London, SE1 9RT, United Kingdom

  • Kingston Hospital NHS Foundation Trust

    London, KT2 7QB, United Kingdom

  • Medway NHS Foundation Trust

    Gillingham, ME7 5NY, United Kingdom

  • Royal Bournemouth Hospital

    Bournemouth, BH7 7DW, United Kingdom

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG, United Kingdom

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool, CH63 4JY, United Kingdom

  • The Princess Alexandra Hospital NHS Trust

    London, CM20 1QX, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ, United Kingdom

  • University College London Hospital

    London, W1T 4TJ, United Kingdom

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD, United Kingdom

  • Velindre University NHS Trust

    Cardiff, CF15 7QZ, United Kingdom

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