Irish Programme for Stratified Prostate Cancer Therapy (iPROSPECT)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03162003|
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : November 17, 2020
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||55 participants|
|Official Title:||Irish Programme for Stratified Prostate Cancer Therapy|
|Actual Study Start Date :||February 2015|
|Actual Primary Completion Date :||August 2020|
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.
Patient with castrate-resistant disease at time of treatment change
- Biomarkers of Androgen Deprivation Therapy (ADT) alone and combined. [ Time Frame: 10 years ]Identification of predictive biomarkers for ADT treatment or ADT combined treatment response in metastatic prostate cancer
- Biomarkers to treatment response [ Time Frame: 10 years ]Identification of predictive biomarker(s) for treatment response in metastatic castrate resistant prostate cancer
- Circulating Tumour Cells (CTC's) [ Time Frame: 10 years ]Analysis of the biology of CTCs from metastatic prostate cancer patients.
Biospecimen Retention: Samples With DNA
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): NCT03162003
|Cork University Hospital, Wilton road|
|Mater Misericordiae University Hospital & Mater Private Hospital|
|Dublin 7, Ireland|
|St James's Hospital, James's street|
|Dublin 8, Ireland|
|Beaumont Hospital, Beaumont|
|Dublin 9, Ireland|
|Adelaide and Meath Hospital incorporating the National Children's Hospital (AMNCH), Tallaght|
|Beacon Hospital, Sandyford|
|St Vincent's University Hospital, Elm Park|
|Sligo University Hospital, The Mall|
|University Hospital Waterford|
|Principal Investigator:||Prof Ray McDermott||SVUH, AMNCH|