CTC Immune Checkpoint

NCT02456571 | Completed

• 1 other identifier: Pro00063296
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will explore the prevalence of expression of four immune checkpoint biomarkers on circulating tumor cells (CTCs) from men with metastatic prostate cancer that are captured by EpCAM via the CellSearch method, and specifically defined as co expressing DAPI and cytokeratin, and lacking CD45 expression.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Change in expression of four immune checkpoint biomarkers (PD-L1, PD-L2, B7-H3, and CTLA-4) on circulating tumor cells (CTCs).

  Baseline to 12 weeks

• Change in expression of four immune checkpoint biomarkers (PD-L1, PD-L2, B7-H3, and CTLA-4) on circulating tumor cells (CTCs).

  Baseline to 14 months (expected time of progression)

Study Arms (4)

Group A

men with mCRPC starting sipuleucel-T (Provenge) with or without abiraterone acetate or enzalutamide will have CTC enumeration and immune checkpoint characterization at baseline, 3 months, 4-12 weeks after completion of sipuleucel-T, and at progression.

Device: CTC biomarker expression prevalence

Group B

men with mCRPC with visceral or high risk disease pre-abiraterone/enzalutamide will have CTC enumeration and immune checkpoint characterization at baseline, 3 months, and progression.

Device: CTC biomarker expression prevalence

Group C

men with high volume metastatic castration sensitive prostate cancer (mCSPC) starting hormonal therapy and docetaxel chemotherapy or who decline docetaxel chemotherapy will have CTC enumeration and immune checkpoint characterization at baseline, 3 months, and progression.

Device: CTC biomarker expression prevalence

Group D

men with enzalutamide or abiraterone acetate resistant mCRPC will have CTC enumeration and immune checkpoint characterization at baseline (i.e. progression on enzalutamide or abiraterone acetate) and 4-12 weeks after completion of next therapy (ex. radium-223 or chemotherapy)

Device: CTC biomarker expression prevalence

Interventions

CTC biomarker expression prevalence DEVICE

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Duke Cancer Institute Patients

You may not qualify if:

• History of intercurrent or past medical or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).
• Treatment with an anthracycline (including mitoxantrone) within 1 week of CTC collection, as anthracyclines cause auto-fluorescence of cells.

Sponsors & Collaborators

• Duke University: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Andrew J Armstrong, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: May 28, 2015
• Study Start: November 1, 2016
• Primary Completion: June 13, 2019
• Study Completion: June 13, 2019
• Last Updated: July 9, 2019

Record last verified: 2019-07

Locations

US (1)