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

Wake Forest University (WFU)

Status: Completed

Conditions: Prostate Carcinoma; Benign Prostatic Hyperplasia

Treatments: Other: Laboratory Biomarker Analysis; Other: Cytology Specimen Collection Procedure

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02425800

NCI-2015-00377 (Registry Identifier)

P30CA012197 (U.S. NIH Grant/Contract)

CCCWFU 85A15 (Other Identifier)

IRB00031636

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

43 participants in 1 patient group

Ancillary-Correlative (human prostate tissue model)

Description:

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.

Treatment:

Other: Cytology Specimen Collection Procedure

Other: Laboratory Biomarker Analysis