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Plasma analysis for response assessment and to direct the management of metastatic prostate cancer

Study ID: 40459
Short Title: PARADIGM
Trust Name: UHD,UHS
Recruitment Site: Royal Bournemouth Hospital,Southampton General Hospital
Disease Area: Urology
Phase: N/A
Expected End Date: 30/09/2024
Postcode: SO16 6YD
BH15 2JB
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

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: A. Planned to start long-term Luteinizing hormone (LH) suppression, or B. within 10 weeks of starting long-term luteinizing hormone releasing hormone (LHRH) antagonist, or C. 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 plasma samples collected as per the study protocol.

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.

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.

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