Clinical trial · Observational
Irish Programme for Stratified Prostate Cancer Therapy
NCT03162003CI-TRIAL-00091821iPROSPECTcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1
- description
- 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.
- label
- Cohort 2
- description
- Patient with castrate-resistant disease at time of treatment change
Primary outcomes (2)
- measure
- Biomarkers of Androgen Deprivation Therapy (ADT) alone and combined.
- timeFrame
- 10 years
- description
- Identification of predictive biomarkers for ADT treatment or ADT combined treatment response in metastatic prostate cancer
- measure
- Biomarkers to treatment response
- timeFrame
- 10 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.