Clinical trial NCT02425800: Human Prostate Tissue Model to Maintain and Study Prostate Cancer Stem Cells
Official title: Optimizing Human Prostate Extracellular Matrix as a Structure for Maintenance and Studying of Prostate Cancer Stem Cells
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Prostatic Hyperplasia
Prostate Carcinoma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-04-24
Enrollment: 43
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men scheduled for a prostatectomy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of viable injected cells
timeFrame: Up to 4 weeks
measure: Ability to make spheres (cluster of cells)
timeFrame: Up to 1 year
measure: Ratio of spheres to the amount of injected cells
timeFrame: Up to 1 year
Secondary outcomes:
measure: Number of alive cells (using flow cytometry)
timeFrame: Up to 28 days
measure: Percentage of the TROP2 positive cells (using flow cytometry)
timeFrame: Up to 28 days
measure: Ability of cells to make glandular structures by observing the structure under microscope and performing immunostaining for epithelial markers like E-Cadherin, beta-catenin
timeFrame: Up to 1 year
measure: Number of CSCs
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center at Wake Forest University
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Ashok K Hemal
role: PRINCIPAL_INVESTIGATOR
References: