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Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
20/09/2019
Funder:
Prostate Cancer UK
Sponsor:
UCL
Chief Investigator:
Gert Attard
Recruitment target:
170
EudraCT number:
N/A
Contact details:
ctc.paradigm@ucl.ac.uk
Lay summary:
PARADIGM
Plasma Analysis for Response Assessment and to DIrect the manaGement of Metastatic prostate cancer
Description
Design: A prospective, observational, biomarker-focused, translational platform, cohort study in newly diagnosed polymetastatic prostate cancer patients starting long-term systemic therapy.
Treatment: N/A
Key inclusion/exclusion criteria:

INCLUSION CRITERIA

1. Able and willing to provide written informed consent
2. Prostate adenocarcinoma confirmed on biopsy obtained in previous 6 months
3. Polymetastatic disease defined as two of the following:

i. Gleason score of ≥ 8,
ii. Presence of ≥3 lesions on bone scan,
iii. Presence of measurable visceral lesion

4. Eastern Cooperative Oncology Group (ECOG) Performance status 0 to 2
5. No medical contra-indications to abiraterone or docetaxel

6. Patients should be either of the following:

i. Planned to start long-term Luteinizing hormone (LH) suppression, or
ii. within 10 weeks of starting long-term LHRH antagonist, or
iii. within 12 weeks of starting LHRH agonist or an anti-androgen when the latter is used in combination with or prior to LHRH agonist for flare protection.

7. Patients should be planned for addition of docetaxel (PARADIGM-D) or abiraterone (PARADIGM-A) 5 to 10 weeks after start of LHRHa (or 7 to 12 weeks if LHRH agonist is started without 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

EXCLUSION CRITERIA

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.

Duration of recruitment: Approximately 18 months
Aim
The overall aim is to determine whether the detection of plasma tumour DNA after two cycles of abiraterone (with prednisone) or docetaxel (with or without prednisone) added after start of androgen deprivation therapy is associated with a worse clinical outcome in newly diagnosed metastatic prostate cancer.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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