Clinical trial · Observational
Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder/Urothelial Cancer
Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy
NCT01050504CI-TRIAL-00120763recruitingClinicalTrials.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 study collects and studies tissue and blood samples from patients with prostate or bladder/urothelial cancer that has recurred (come back) at or near the same place as the original (primary) tumor or has spread to other parts of the body. Studying samples of blood and tissue samples from patients with prostate or bladder/urothelial cancer in the laboratory may help doctors learn more about new biomarkers, potential drug targets, and resistance developing in response to treatment. It may also help doctors find better ways to treat the cancer.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Localized Renal Pelvis and Ureter Urothelial Carcinoma | Renal Pelvis and Ureter Urothelial Carcinoma | CURATED_BROADER | 0.78 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Metastatic Malignant Neoplasm in the Bone | — | UNRESOLVED | — |
| Metastatic Malignant Neoplasm in the Soft Tissues | — | UNRESOLVED | — |
| Metastatic Renal Pelvis and Ureter Urothelial Carcinoma | Renal Pelvis and Ureter Urothelial Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Bladder Carcinoma | Bladder Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Renal Pelvis and Ureter Urothelial Carcinoma | Renal Pelvis and Ureter Urothelial Carcinoma | CURATED_BROADER |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-correlative (blood and tissue collection)
- description
- Patients undergo collection of blood and tissue samples for analysis via mutation mapping, DNA sequencing, gene expression microarray, and gene profiling.
- interventionNames
- Other: Cytology Specimen Collection Procedure
- Other: Laboratory Biomarker Analysis
Primary outcomes (3)
- measure
- DNA genomic sequencing
- timeFrame
- Up to 6 years
- measure
- Gene expression profile using microarray assays
- timeFrame
- Up to 6 years
- measure
- Mutation mapping using the OncoMap and other genotyping techniques
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with localized and/or metastatic bladder/urothelial or prostate cancer who have disease in the primary organ, biopsy accessible bone metastases (collaborating radiologists will determine if bone metastasis is appropriate for biopsy) or soft tissue metastases are eligible; men and women without cancer are eligible to have blood or normal tissue collected if acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder); in patients without malignancy, no additional tissue beyond that necessary for care will be procured * Ability to adequately understand and give informed consent * Local or metastatic disease to soft tissue or bone at sites accessible to biopsy with minimal risk of complications Or the ability to obtain tissue with minimal risk of complication from a surgical procedure being conducted as a part of another research study Or for standard of care purposes or patients who have archival tissue collected for research or standard of care who are willing to donate archival tissue for this study * Alternatively, men and women without cancer or who are at risk of developing cancer are eligible to have blood or normal tissue collected if acquired; tissue will only be acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder; in patients without malignancy, no additional tissue beyond that necessary for care will be procured * Platelet count \> 50,000 * White blood cell (WBC) \> 1,500 * Hemoglobin (Hgb) \> 8.0 * International normalized ratio (INR) \< 1.5 * Partial thromboplastin time (PTT) \< 45 * No history of excessive unexplained bleeding from previous surgery Exclusion Criteria: * Patients unable to stop chronic anticoagulation with warfarin or Lovenox for less than 3 days * Serious or uncontrolled infection * Treatment with a vascular endothelial growth factor (VEGF) inhibitor (such as Avastin) within the past 28 days
References
Publications (0)
Data not yet available
No reference posted for this study.