Plasma Analysis for Response Assessment and to DIrect the manaGement of Metastatic Prostate Cancer (PARADIGM)
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|ClinicalTrials.gov Identifier: NCT04067713|
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : March 11, 2020
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|
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.
|Study Type :||Observational|
|Estimated Enrollment :||170 participants|
|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|
Newly diagnosed metastatic prostate cancer patients starting long term therapy with Docetaxel with androgen deprivation therapy (ADT).
Newly diagnosed metastatic prostate cancer patients starting long term therapy with Abiraterone with androgen deprivation therapy (ADT).
- 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 ]
- Symptomatic or asymptomatic progression of or new distant metastases confirmed by imaging.
- Symptomatic progression of cancer in the prostate confirmed by imaging,
- Serum PSA progression in PARADIGM-D.
- Prostate cancer specific death, defined as time from start of abiraterone or docetaxel with ADT to death from prostate cancer.
- 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
- 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.
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
|Contact: Salahah Ahmed-Laskarfirstname.lastname@example.org|
|Contact: Millenn Chiweweemail@example.com|
|University College London Hospital||Recruiting|
|London, United Kingdom|
|Contact: Gert Attard|