Prostate CanceriPROSPECTNCT03162003
Irish Programme for Stratified Prostate Cancer Therapy
An observational study of Prostate Cancer, run by Cancer Trials Ireland at 9 sites in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 55 participants
- Where
- 9 sitesIreland
- Study dates
- Feb 2015to 8 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with castrate sensitive (cohort 1) or castrate resistant (cohort 2) metastatic prostate cancer.
Who may be able to join
- Stage 4 mPCa as confirmed by CT/MRI or by bone scan
- 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)
- Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 28 days prior to recruitment
- Life expectancy of at least 6 months
- Ability to give written informed consent obtained before any study-related procedures
- Age ≥ 18 years and male
Who cannot join
- Diagnosis of or treatment for another systemic malignancy within 2 years before study entry.*
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Ireland9 sites
Cork University Hospital, Wilton road
Cork
Adelaide and Meath Hospital incorporating the National Children's Hospital (AMNCH), Tallaght
Dublin
Beacon Hospital, Sandyford
Dublin
Beaumont Hospital, Beaumont
Dublin
Mater Misericordiae University Hospital & Mater Private Hospital
Dublin
St James's Hospital, James's street
Dublin
St Vincent's University Hospital, Elm Park
Dublin
Sligo University Hospital, The Mall
Sligo
University Hospital Waterford
Waterford
About this study
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.
Read the 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.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Biomarkers to treatment response
Identification of predictive biomarker(s) for treatment response in metastatic castrate resistant prostate cancer
Measured: 10 years
Secondary outcomes (1)
Circulating Tumour Cells (CTC's)
Analysis of the biology of CTCs from metastatic prostate cancer patients.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study startFeb 2015
- Primary completionAug 2020
- Study completion8 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Prof Ray McDermott, Principal investigator, SVUH, AMNCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162003
- Sponsor's protocol ID
- CTRIAL-IE (ICORG) 14-04
- Acronym
- iPROSPECT
- Status last verified
- Jul 2025
- First submitted
- 19 May 2017
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irish Programme for Stratified Prostate Cancer Therapy
- ClinicalTrials.gov ID
- NCT03162003
- Acronym / sponsor ID
- iPROSPECT / CTRIAL-IE (ICORG) 14-04
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Feb 2015 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with castrate sensitive (cohort 1) or castrate resistant (cohort 2) metastatic prostate cancer.
Key inclusion criteria (6 listed)
- Stage 4 mPCa as confirmed by CT/MRI or by bone scan
- 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)
- Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 28 days prior to recruitment
- Life expectancy of at least 6 months
- Ability to give written informed consent obtained before any study-related procedures
Key exclusion criteria (2 listed)
- Diagnosis of or treatment for another systemic malignancy within 2 years before study entry.*
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Circulating Tumour Cells (CTC's)
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
RecruitingPhase 1/2
Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
Metastatic Prostate Cancer
RecruitingPhase 1
A Study of JNJ-98768111 in Participants With Advanced Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 3
A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
Prostatic Neoplasms, Castration-Resistant
RecruitingPhase 2
Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells
Metastatic Prostate Adenocarcinoma With Neuroendocrine Differentiation, Metastatic Prostate Neuroendocrine Carcinoma
RecruitingPhase 3
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial
Metastatic Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Ray McDermott principal investigator
SVUH, AMNCH
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Cancer Trials Ireland at 9 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers of Androgen Deprivation Therapy (ADT) alone and combined. (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.