NCT02425800

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 28, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2018

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2021

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

3.3 years

First QC Date

March 24, 2015

Last Update Submit

August 30, 2021

Conditions

Benign Prostatic HyperplasiaProstate Carcinoma

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Number of alive cells (using flow cytometry)

    Up to 28 days

  • Percentage of the TROP2 positive cells (using flow cytometry)

    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

    Up to 1 year

  • Number of CSCs

    Up to 1 year

Study Arms (1)

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: Cytology Specimen Collection ProcedureOther: Laboratory Biomarker Analysis

Interventions

Cytology Specimen Collection ProcedureOTHER

Undergo collection of tissue samples

Also known as: Cytologic Sampling
Ancillary-Correlative (human prostate tissue model)
Laboratory Biomarker AnalysisOTHER

Correlative studies

Ancillary-Correlative (human prostate tissue model)

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men scheduled for a prostatectomy

You may qualify if:

  • Male patients scheduled for a prostatectomy
  • Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document

You may not qualify if:

  • Patients with prostate involvement secondary and as a result of metastasis or spread of cancerous cells from other organs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

prostate tissue

MeSH Terms

Conditions

Prostatic HyperplasiaProstatic Neoplasms

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Ashok K Hemal

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2015

First Posted

April 24, 2015

Study Start

July 28, 2015

Primary Completion

November 5, 2018

Study Completion

August 3, 2021

Last Updated

September 1, 2021

Record last verified: 2021-08

Locations

US(2)