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Plasma Analysis for Response Assessment and to DIrect the manaGement of Metastatic Prostate Cancer (PARADIGM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067713
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : March 11, 2020
Sponsor:
Collaborator:
Epic Sciences
Information provided by (Responsible Party):
University College, London

Brief Summary:

This research study is looking into plasma tumour deoxyribonucleic acid (ptDNA), a substance that is shed by cancer cells and can be detected in blood samples. Analysing ptDNA may therefore be able to provide more information about the characteristics of prostate cancer.

This study will involve taking additional blood samples during standard treatment. The samples will be analysed in laboratories for levels of Prostate Specific Antigen (PSA); which gives information on the activity of the cancer; ptDNA; circulating tumour cells (ones that are derived from the cancer) (CTCs) and cells that affect immune system.

The PARADIGM study is not, therefore, testing a new drug. Instead, the study is investigating if a new blood test can provide information about which current treatments for prostate cancer will work best for future patients with this disease.

In the future and PARADIGM's ultimate aim is to identify which of the current treatment options will work best for patients. The research may also identify new opportunities for the development of drugs potentially useful in treating prostate cancer.


Condition or disease
Metastatic Prostate Cancer

Detailed Description:

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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Study Type : Observational
Estimated Enrollment : 170 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Plasma Analysis for Response Assessment and to DIrect the manaGement of Metastatic Prostate Cancer
Actual Study Start Date : September 20, 2019
Estimated Primary Completion Date : November 28, 2022
Estimated Study Completion Date : April 28, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort
PARADIGM-D
Newly diagnosed metastatic prostate cancer patients starting long term therapy with Docetaxel with androgen deprivation therapy (ADT).
PARADIGM- A
Newly diagnosed metastatic prostate cancer patients starting long term therapy with Abiraterone with androgen deprivation therapy (ADT).



Primary Outcome Measures :
  1. Progression Free Survival (PFS) for PARADIGM-D and PARADIGM-A will be reported separately and will be defined as the interval from start of docetaxel or abiraterone to disease failure as determined by at least one or more of these factors [ Time Frame: Following completion of cycle 3 of each patient - PARADIGM A, cycle length is 28 days. PARADIGM D, cycle length is 21 days ]
    1. Symptomatic or asymptomatic progression of or new distant metastases confirmed by imaging.
    2. Symptomatic progression of cancer in the prostate confirmed by imaging,
    3. Serum PSA progression in PARADIGM-D.
    4. Prostate cancer specific death, defined as time from start of abiraterone or docetaxel with ADT to death from prostate cancer.


Secondary Outcome Measures :
  1. Prostate Cancer Specific Survival (PCSS) [ Time Frame: 5 years after last patient has been registered ]
    defined as time from start of abiraterone or docetaxel with ADT to death from prostate cancer

  2. Overall survival (OS) [ Time Frame: 5 years after last patient has been registered ]
    defined as time from start of abiraterone or docetaxel with ADT to death from any cause.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Newly diagnosed metastatic prostate cancer patients starting long term therapy with either abiraterone (PARADIGM A) or Docetaxel (PARADIGM D) with androgen deprivation therapy (ADT).

This is a UK based trial recruiting from approximately 10 sites over 18 months with a maximum follow up for 5 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.

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 plasma samples collected as per the study protocol.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067713


Contacts
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Contact: Salahah Ahmed-Laskar 02076799112 ctc.paradigm@ucl.ac.uk
Contact: Millenn Chiwewe 02076799714 ctc.paradigm@ucl.ac.uk

Locations
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United Kingdom
University College London Hospital Recruiting
London, United Kingdom
Contact: Gert Attard         
Sponsors and Collaborators
University College, London
Epic Sciences
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT04067713    
Other Study ID Numbers: UCL/18/0513
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases