Human Prostate Tissue Model to Maintain and Study Prostate Cancer Stem Cells

Study Overview
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Brief Summary
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This pilot research trial studies the use of a human prostate tissue model to maintain and study prostate cancer stem cells. A human prostate tissue model uses leftover tissue that was removed during surgery from patients with non-cancerous enlargement of the prostate (benign prostatic hyperplasia) and may create an environment similar to the natural environment of the human body. Prostate cancer stem cells are cells that cause cancer to grow. Using real tissue to create an environment to study stem cells may help doctors learn more about how they work and how they respond to treatments.

Detailed Description
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PRIMARY OBJECTIVES: I. To optimize a decellularized prostate tissue model for the maintenance of prostate cancer stem cells. SECONDARY OBJECTIVES: I. To investigate the self-renewal and differentiation ability of human prostate cancer stem cells (CSCs) (tumor-associated calcium signal transducer 2 [TROP2]+ cells) in the above mentioned decellularized prostate tissue model. II. To compare the number of CSCs according to key patient characteristics, including race, age, Gleason, metastasis status, and previous cancer treatment(s). OUTLINE: Tissue samples are collected from patients with benign prostatic hyperplasia for decellularization and preparation as human extracellular matrix for growing human prostate CSCs. Tissue samples are also collected from patients with prostate cancer for the analysis of TROP2+ cells by flow cytometry.

Official Title
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Optimizing Human Prostate Extracellular Matrix as a Structure for Maintenance and Studying of Prostate Cancer Stem Cells

Conditions
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Benign Prostatic Hyperplasia, Prostate Carcinoma

Intervention / Treatment
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* Other: Cytology Specimen Collection Procedure
* Other: Laboratory Biomarker Analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patients scheduled for a prostatectomy Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Exclusion Criteria: Patients with prostate involvement secondary and as a result of metastasis or spread of cancerous cells from other organs
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ancillary-Correlative (human prostate tissue model)<br>Tissue samples are collected from patients with benign prostatic hyperplasia for decellularization and preparation as human extracellular matrix for growing human prostate CSCs. Tissue samples are also collected from patients with prostate cancer for the analysis of TROP2+ cells by flow cytometry. Cytology Specimen Collection Procedure. Laboratory Biomarker Analysis. | Other: Cytology Specimen Collection Procedure<br>* Undergo collection of tissue samples<br>* Other names: Cytologic Sampling;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of viable injected cells | Optimization of a decellularized prostate tissue model for the maintenance of prostate cancer stem cells, as measured by the viability of the injected cells at different time points (1 day, 2 days, 3 days, 1 week, 2 weeks, 3 weeks, and 4 weeks) will be evaluated. For each day the percent viable and associated confidence interval will be reported. | Up to 4 weeks | 
| Ability to make spheres (cluster of cells) | Also to evaluate the primary objective it will be determined if cells are able to make spheres and if so, confidence intervals for the proportion of injected cells that are able to make spheres will be estimated and provided. | Up to 1 year | 
| Ratio of spheres to the amount of injected cells | Also to evaluate the primary objective it will be determined if cells are able to make spheres and if so, confidence intervals for the proportion of injected cells that are able to make spheres will be estimated and provided. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of alive cells (using flow cytometry) | To address the secondary objective of investigating the self-renewal and differentiation ability of human prostate CSCs (TROP2+ cells) decellularized prostate tissue model, the number of alive cells will be observed and an estimate (with confidence interval) of the percentage of the TROP2 positive cells will be obtained at days 3, 7, 14, 21, and 28. | Up to 28 days | 
| Percentage of the TROP2 positive cells (using flow cytometry) | To address the secondary objective of investigating the self-renewal and differentiation ability of human prostate CSCs (TROP2+ cells) decellularized prostate tissue model, the number of alive cells will be observed and an estimate (with confidence interval) of the percentage of the TROP2 positive cells will be obtained at days 3, 7, 14, 21, and 28. | Up to 28 days | 
| Ability of cells to make glandular structures by observing the structure under microscope and performing immunostaining for epithelial markers like E-Cadherin, beta-catenin | Estimates and confidence intervals for the percent of cells that are able to make glandular structures will also be provided. | Up to 1 year | 
| Number of CSCs | The relationships between patient characteristics (including race, age, Gleason, metastasis status, and previous cancer treatment[s]) and the number of CSC's will also be investigated. An estimate of the number of CSC's for each level of categorical characteristics and a correlation for those patient characteristics which are continuous will be presented. | Up to 1 year |