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The purpose of the trial is to investigate new clinical tests that could predict what treatments work best for certain patients with advanced prostate cancer by identifying markers and indicators present in blood and tissue which correlate with treatment response.
Prostate Cancer (PCa) is a complex disease and not all patients respond to every treatment available.
This study aims to investigate new clinical tests based on simple and routine blood tests to allow men with PCa and their doctors to choose the correct treatment for their metastatic PCa.
In this way, only men likely to respond to the specific treatment will be chosen, sparing unnecessary or prolonged treatment for those who will not respond and allowing them to avail of alternative therapies likely to have more benefit. This is termed personalised therapy.
The study will perform research on biological elements present in the blood including deoxyribonucleic acids (DNA), ribonucleic acid (RNA), protein and circulating tumour cells (CTCs) which are cancer cells that have spread beyond the prostate gland and can be found floating in the blood. Clinical data will be correlated to research findings to form conclusions on personalised therapy.
Additional optional sub studies include; magnetic resonance imaging (MRI) with a biopsy of another tumour in a different site of their body such as bone, lung or liver (metastatic biopsy), metastatic biopsy only and biopsies of the fluid of solid part of the bone. These optional components provide more detailed information on prostate cancer and how men are responding to treatment. The research results from these optional sub studies will be correlated with the research analysis from the blood samples and clinical data and will help to make treatment decisions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Patient with visceral disease and/or bone lesions (excluding patients who only have nodal disease), who have commenced or are about to commence ADT and whose disease has not shown any evidence of castration resistance. | ||
| Cohort 2 | Patient with castrate-resistant disease at time of treatment change |
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| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers of Androgen Deprivation Therapy (ADT) alone and combined. | Identification of predictive biomarkers for ADT treatment or ADT combined treatment response in metastatic prostate cancer | 10 years |
| Biomarkers to treatment response | Identification of predictive biomarker(s) for treatment response in metastatic castrate resistant prostate cancer | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Circulating Tumour Cells (CTC's) | Analysis of the biology of CTCs from metastatic prostate cancer patients. | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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Men with castrate sensitive (cohort 1) or castrate resistant (cohort 2) metastatic prostate cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Prof Ray McDermott | SVUH, AMNCH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cork University Hospital, Wilton road | Cork | Ireland | ||||
| Adelaide and Meath Hospital incorporating the National Children's Hospital (AMNCH), Tallaght |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Whole blood processed to Plasma, serum and filtered for Circulating Tumour Cells.
| Dublin |
| Ireland |
| Beacon Hospital, Sandyford | Dublin | Ireland |
| Beaumont Hospital, Beaumont | Dublin | Ireland |
| Mater Misericordiae University Hospital & Mater Private Hospital | Dublin | Ireland |
| St James's Hospital, James's street | Dublin | Ireland |
| St Vincent's University Hospital, Elm Park | Dublin | Ireland |
| Sligo University Hospital, The Mall | Sligo | Ireland |
| University Hospital Waterford | Waterford | Ireland |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |