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NCT Number: NCT02425800

Human Prostate Tissue Model to Maintain and Study 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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Carcinoma Prostatic Diseases Prostatic Hyperplasia Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytology Specimen Collection Procedure

Other

Undergo collection of tissue samples

Other names: Cytologic Sampling

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Percent of viable injected cells

    Time frame: 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.

  2. Ability to make spheres (cluster of cells)

    Time frame: 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.

  3. Ratio of spheres to the amount of injected cells

    Time frame: 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.

Secondary outcomes

  1. Number of alive cells (using flow cytometry)

    Time frame: 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.

  2. Percentage of the TROP2 positive cells (using flow cytometry)

    Time frame: 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.

  3. Ability of cells to make glandular structures by observing the structure under microscope and performing immunostaining for epithelial markers like E-Cadherin, beta-catenin

    Time frame: Up to 1 year

    Estimates and confidence intervals for the percent of cells that are able to make glandular structures will also be provided.

  4. Number of CSCs

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2021
First posted
Apr 24, 2015
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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