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

Completed

• Conditions: Prostate Carcinoma; Benign Prostatic Hyperplasia
• Interventions: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis

• Registration Number: NCT02425800
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-24
• Study Start: 2015-07-28
• Primary Completion: 2018-11-05
• Status Verified: 2021-08
• Study Completion: 2021-08-03
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 43

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

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Exclusion Criteria

• Patients with prostate involvement secondary and as a result of metastasis or spread of cancerous cells from other organs

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (human prostate tissue model)	Laboratory Biomarker Analysis	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.
Ancillary-Correlative (human prostate tissue model)	Cytology Specimen Collection Procedure	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.

Primary Outcome Measures

Name	Time	Method
Ability to make spheres (cluster of cells)	Up to 1 year	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.
Ratio of spheres to the amount of injected cells	Up to 1 year	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.
Percent of viable injected cells	Up to 4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of the TROP2 positive cells (using flow cytometry)	Up to 28 days	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.
Ability of cells to make glandular structures by observing the structure under microscope and performing immunostaining for epithelial markers like E-Cadherin, beta-catenin	Up to 1 year	Estimates and confidence intervals for the percent of cells that are able to make glandular structures will also be provided.
Number of alive cells (using flow cytometry)	Up to 28 days	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.
Number of CSCs	Up to 1 year	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.

Trial Locations

Locations (2)

Comprehensive Cancer Center at Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States