A Pilot Study to Assess the Immunogenicity of Candidate PSA Peptides for a Prostate Cancer Vaccine

NCT02485964 | Completed Results

• 1 other identifier: 204374
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To measure antigen-specific interferon-secretion by enzyme-linked immunospot (ELISPOT) assay, which measures antigen-specific interferon-secretion.

Conditions

Prostate Cancer

Keywords

Vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Antigen-specific Interferon- Secretion as Measured by Enzyme-linked Immunospot (ELISPOT) Assay

  The spots formed by interferon-gamma-secreting T-cells will be counted with an automated ELISPOT analyzer (AID ELISPOT Classic Reader; Autoimmune Diagnostika GmbH, Strassberg, Germany). The average spot-forming units (SFU) per antigen will be calculated. A response will be considered positive when the average SFU in wells with a given peptide was at least twice that of the average SFU in the no-peptide control wells.

  At time of consent

Study Arms (1)

Blood Draw Only

OTHER

One time blood draw at time of consent; No treatment

Other: Blood draw

Interventions

Blood draw OTHER

One time blood draw at time of consent. Blood will be stored until all subjects have been enrolled and then the enzyme-linked immunospot (ELISPOT) assay will be done to measure the antigen-specific interferon secretion.

Blood Draw Only

Eligibility Criteria

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

You may qualify if:

• Histological documented diagnosis of prostate cancer
• years of age or older
• Signed informed consent form approved by the University of Arkansas for Medical Sciences (UAMS) Institutional Review Board (IRB)

You may not qualify if:

• Subjects must have no other current malignancies.
• Subjects with prior history at any time of any basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration.
• Subjects with other malignancies are eligible if they have been continuously disease free for ≥ 5 years prior to the time of registration

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Beth Scanlan
• Organization: University of Arkansas for Medical Sciences

bscanlan@uams.edu

5016868274

Study Officials

• Konstantinos Arnaoutakis, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: June 30, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 7, 2021
• Results First Posted: September 10, 2021

Record last verified: 2019-01

Locations

US (1)