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

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

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia; Prostate Carcinoma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Cytology Specimen Collection Procedure

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.

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157-1082
      • Comprehensive Cancer Center at Wake Forest University
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Men scheduled for a prostatectomy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Ancillary-Correlative (human prostate tissue model); 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: Laboratory Biomarker Analysis; Correlative studies; Other: Cytology Specimen Collection Procedure; Undergo collection of tissue samples; Other Names: Cytologic Sampling

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Ashok K Hemal, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 28, 2015
• Primary Completion (ACTUAL): November 5, 2018
• Study Completion (ACTUAL): August 3, 2021

Study Registration Dates

• First Submitted: March 24, 2015
• First Submitted That Met QC Criteria: April 21, 2015
• First Posted (ESTIMATE): April 24, 2015

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: IRB00031636; P30CA012197 (U.S. NIH Grant/Contract); NCI-2015-00377 (REGISTRY: CTRP (Clinical Trial Reporting Program)); CCCWFU 85A15 (OTHER: Comprehensive Cancer Center of Wake Forest University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No