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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425800
• Other study ID #: IRB00031636
• Secondary ID: NCI-2015-00377CC
• Status: Completed
• Start date: July 28, 2015
• Est. completion date: August 3, 2021

Study information

• Verified date: August 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 3, 2021
• Est. primary completion date: November 5, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostate Carcinoma
• Prostatic Hyperplasia
• Prostatic Neoplasms

Intervention

Other:
• Cytology Specimen Collection Procedure
Undergo collection of tissue samples
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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