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Contact Information:

Prof Gerhardt Attard
g.attard@ucl.ac.uk


Millenn Chiwewe
ctc.paradigm@ucl.ac.uk


Study Location:

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Be Part of Research - Trial Details - PARADIGM

PARADIGM

Completed

Open to: Male

Age: 18 Years - N/A

Medical Conditions

Malignant neoplasms of male genital organs


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


In the UK, prostate cancer is the most common cancer in men and with about 1 in 8 men diagnosed with prostate cancer in their lifetime. Up to a third of prostate cancer deaths occur when cancer spreads to other parts of the body known as metastatic prostate cancer, which is a major healthcare burden. Currently, physicians use a maximum of six cycles of Docetaxel and continue abiraterone until disease progression with long term androgen deprivation therapy (ADT).

There is no early test to indicate if treatment is working for patients with metastatic prostate cancer. Currently Prostate Specific Antigen (PSA) is not sensitive enough to guide treatment alone. Studies in colorectal, lung and prostate cancers have started looking at substance called Plasma tumour deoxyribonucleic acid (ptDNA) and correlated presence of ptDNA will early relapse. Therefore, this study will investigate if the detection of ptDNA after initiating treatment is associated a worse clinical outcome. Our ultimate aim, is to identify which of the current treatment options will work best for patients in the future. This research may also identify new targets for the development of new drugs to test in clinical trials in the future.

Assessments will include blood taken before and during treatment and at cancer progression. In selected centres, an optional Whole Body Magnetic Resonance Imaging (WBMRI) will be performed before and during treatment for those patients who are eligible. Patients will be followed up for a maximum of 5 years at the time they register onto the study. We expect recruitment duration to be 18 months.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

20 Sep 2019 30 Nov 2024

Observational

Observational type: Cohort study;



You can take part if:



You may not be able to take part if:


1. Medically unsuitable for either abiraterone, prednisolone or docetaxel. 2. Concurrent or planned for (within the first 5 cycles of docetaxel or abiraterone) treatment with any experimental drugs, oestrogen patches radiotherapy or surgery to the primary tumour. Patients randomised to the standard of care (SOC) arm in open-label clinical trials are eligible. Patients who are still to be randomised to STAMPEDE may be included where the randomisation will be limited to SOC or arm K. Patients can participate in other observational studies. 3.Prior systemic therapy for prostate cancer other than for LHRHa +/- anti-androgen (started within the time limits defined in inclusion criterion 6). 4.Metastatic brain disease or leptomeningeal disease. 5.Any surgery planned prior to Cycle 3 Day 1 (C3 D1) 6.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) 7.Patients who consent to the whole-body magnetic resonance imaging (WBMRI) translational sub-study should have no contraindications to MRI as per local guidelines.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • St Bartholomew's Hospital
    West Smithfield
    London
    Greater London
    EC1A 7BE
  • Croydon University Hospital
    London Road
    Croydon
    Surrey
    CR7 7YE
  • Guy's Hospital
    Great Maze Pond
    London
    Greater London
    SE1 9RT
  • Beatson West Of Scotland Cancer Centre
    1053 Great Western Road
    Glasgow
    G12 0YN
  • ROYAL BOURNEMOUTH GENERAL HOSPITAL
    RDZ20@2.16.840.1.113883.2.1.3.2.4.18.48
  • Doncaster Royal Infirmary
    Armthorpe Road
    Doncaster
    South Yorkshire
    DN2 5LT
  • Medway Maritime Hospital
    Windmill Road
    Gillingham
    Kent
    ME7 5NY

Millenn Chiwewe
ctc.paradigm@ucl.ac.uk


Prof Gerhardt Attard
g.attard@ucl.ac.uk



The study is sponsored by University College London and funded by PROSTATE CANCER UK .





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for Trial ID: CPMS 40459

Last updated 02 May 2025

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