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Trial record 1 of 1 for:    iPROSPECT | Ireland
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Irish Programme for Stratified Prostate Cancer Therapy (iPROSPECT)

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ClinicalTrials.gov Identifier: NCT03162003
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland

Brief Summary:
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.

Condition or disease
Prostate Cancer

Detailed Description:

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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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Irish Programme for Stratified Prostate Cancer Therapy
Actual Study Start Date : February 2015
Actual Primary Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort
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



Primary Outcome Measures :
  1. 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

  2. Biomarkers to treatment response [ Time Frame: 10 years ]
    Identification of predictive biomarker(s) for treatment response in metastatic castrate resistant prostate cancer


Secondary Outcome Measures :
  1. 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
Whole blood processed to Plasma, serum and filtered for Circulating Tumour Cells.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men with castrate sensitive (cohort 1) or castrate resistant (cohort 2) metastatic prostate cancer.
Criteria

Inclusion Criteria:

  1. Stage 4 mPCa as confirmed by CT/MRI or by bone scan
  2. 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 1) Or Patient with castrate-resistant disease at time of treatment change (cohort 2)
  3. Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 28 days prior to recruitment
  4. Life expectancy of at least 6 months
  5. Ability to give written informed consent obtained before any study-related procedures
  6. Age ≥ 18 years and male

Exclusion Criteria:

  1. Diagnosis of or treatment for another systemic malignancy within 2 years before study entry.*
  2. Any evidence of residual disease from a previously diagnosed malignancy. *Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection

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): NCT03162003


Locations
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Ireland
Cork University Hospital, Wilton road
Cork, Ireland
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
Dublin, Ireland
Beacon Hospital, Sandyford
Dublin, Ireland
St Vincent's University Hospital, Elm Park
Dublin, Ireland
Sligo University Hospital, The Mall
Sligo, Ireland
University Hospital Waterford
Waterford, Ireland
Sponsors and Collaborators
Cancer Trials Ireland
Investigators
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Principal Investigator: Prof Ray McDermott SVUH, AMNCH
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Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT03162003    
Other Study ID Numbers: CTRIAL-IE (ICORG) 14-04
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Prostatic Diseases