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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:

PARADIGM - A  ARSI (Androgen Receptor Signalling Inhibitor)
-Enzalutamide 
-Apalutamide
-Abiraterone 

PARADIGM - D
-Docetaxel

Other standard of care treatments include  ADT ( LHRA agonist and antagonist) and anti-androgens such as bicalutamide.

Key inclusion/exclusion criteria:

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 last14 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.
Duration of recruitment: Approximately 18 months
Aim
To determine whether the detection of plasma tumour DNA (ptDNA) after two or three cycles of ARSI or docetaxel added after start of ADT 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.
NameVersionCurrent versRelease dateDownload
02. PARADIGM_Protocol (current)N/A Current 17/07/2020
02. PARADIGM_Protocol Version History LogN/A Current 31/07/2020
Guide to Downloading & Extracting Docs from the websiteN/A Current
Trial documents
NameTypeVersionCurrent versRelease dateDownload
01. Trial ManagementOtherN/A Current
02. Protocol_Superseded (1)OtherN/A Current
02. Protocol_Superseded (2)OtherN/A Current
02. Protocol_Superseded (3)OtherN/A Current
03. Patient InformationOtherN/A Current
04. Ethics and RegulatoryOtherN/A Current
06. Site and Staff InformationOtherN/A Current
07. Patient RecruitmentOtherN/A Current
08. LaboratoryOtherN/A Current
09. Data ManagementOtherN/A Current
10. Safety ReportingOtherN/A Current
11. Sponsor Monitoring ActivitiesOtherN/A Current
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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