Clinical trial · Observational
Study to Determine the Feasibility, Evaluability and Variability in Markers of Drug Action in Castration Resistant Prostate Cancer
BIOMETHS Study. A Methodology Study to Determine the Feasibility, Evaluability and Temporal Variability in Candidate Pharmacodynamic Markers of Drug Action in Castration Resistant Prostate Cancer
NCT02424448CI-TRIAL-00023230BIOMETHScompletedClinicalTrials.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)
This is a biopsy feasibility study in which patients with castration resistant prostate cancer (CRPC) will be asked to donate primary and metastatic tumour tissue (both archival and de novo), blood samples, a urine specimen and clinical data for research.
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 |
|---|---|---|---|
| Metastatic Castration Resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsies, blood and urine samples | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Metastatic CRPC
- description
- Patients with metastatic prostate cancer post maximal androgen blockade (MAB) with primary or metastatic cancer deposits amenable to biopsy. Patients will have biopsies, blood and urine samples taken.
- interventionNames
- Procedure: Biopsies, blood and urine samples
Primary outcomes (4)
- measure
- Percentage of formalin fixed cancer tissue samples evaluable for immunohistochemical analysis
- timeFrame
- Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)
- measure
- Baseline levels of biomarkers in formalin fixed cancer tissue samples
- timeFrame
- Samples taken in session 1 (1 to 3 visits) and then 7 days +/- 3 days at session 2 (1 to 3 visits)
- measure
- Intra-lesion temporal variability between formalin fixed cancer tissue samples
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with metastatic prostate cancer post maximal androgen blockade (MAB) with primary or metastatic cancer deposits amenable to biopsy * Patients aged 18 years and older * Histologically or cytologically confirmed adenocarcinoma of the prostate * World Health Organisation (WHO) performance status 0 to 2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks * Provision of archival tumour sample for PTEN status determination as directs group assignment * Provision of written informed consent * Provision of cancer tissue samples, willing to undergo 1-3 biopsies on 2 separate occasions * No change of cancer treatment anticipated until final biopsy/ blood samples have been taken * Serum testosterone level \<50 ng/dL sustained by medical or surgical castration Exclusion Criteria: * Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) * Previous enrolment in the present study * As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease) * Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study * Any investigational agents or study drugs from a previous clinical study within 30 days of the first tissue collection * Radiotherapy to lesion to be biopsied within 4 weeks of biopsy * Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment * Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements * Patients at increased risk of bleeding as a result of biopsy * History of bleeding disorders or thrombocytopenia (platelets \<100) * Concomitant treatment with anticoagulant therapy such as warfarin/low molecular weight heparin (Aspirin not contra-indicated but consider temporary cessation if biopsy site has higher risk of bleeding e.g. liver) * Current urinary tract infection (UTI) or prostatitis * Known infection with HIV, Hepatitis B or Hepatitis C
References
Publications (0)
Data not yet available
No reference posted for this study.