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Prostate CancerPhase 2NCT02153918

Vaccine Plus Booster Shots in Men With Prostate Cancer Undergoing Treatment With Radical Prostatectomy

A Phase 2 study testing PROSTVAC-V/TRICOM and PROSTVAC-F/TRICOM in people with Prostate Cancer and Prostatic Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Some men with prostate cancer have their prostate glands removed. The cancer can still come back. Researchers want to know if receiving a vaccine before prostate removal surgery can lead to less recurrence. Read more about this study

Who is it for?
Ages 18 to 100 years, men only
What is being tested?
PROSTVAC-V/TRICOM and PROSTVAC-F/TRICOM
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
31 May 2014to 16 Jan 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Prior splenectomy.
  • The recombinant vaccinia vaccine should not be administered if the following apply to either recipients or, for at least 3 weeks after vaccination, their close household contacts (Close household contacts are those who share housing or have close physical contact):
  • Persons with active or a history of eczema or other eczematoid skin disorders
  • Those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne or other open rashes or wounds) until condition resolves
  • Pregnant or nursing women; children under 3 years of age
  • Patients should have no evidence, as listed below, of being immunocompromised:
Show all 14Show fewer
  • HIV positivity due to the potential for decreased tolerance and risk for severe side effects.
  • Hepatitis B or C positivity.
  • Concurrent use of topical steroids (including steroid eye drops) or systemic steroids. This is to avoid immunosuppression which may lead to potential complications with vaccinia (priming vaccination). Nasal or inhaled steroid use is permitted.
  • Patients with known allergy to eggs.
  • Other serious intercurrent illness.
  • Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or New York Heart Association class II-IV congestive heart failure.
  • Patients with significant autoimmune disease that is active or potentially life threatening if activated.
  • Patients with clinically significant cardiomyopathy requiring treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: A Phase II Study of Neoadjuvant rFowlpox-PSA (L155)-TRICOM (Prostvac-F/TRICOM) in Combination With rVaccinia-PSA (L155)-TRICOM (Prostvac-V/TRICOM) in Men With Prostate Cancer Undergoing Treatment With Radical Prostatectomy

Background:

  • Some men with prostate cancer have their prostate glands removed. The cancer can still come back. Researchers want to know if receiving a vaccine before prostate removal surgery can lead to less recurrence.
Read more

Objective:

  • To see if a vaccine and booster shots given to men with prostate cancer before surgery changes the immune cells in the prostate gland.

Eligibility:

  • Men age 18 and older who have prostate cancer that has not spread, and who want to have their prostate glands removed as treatment.

Design:

  • Participants will be screened by their regular cancer care. They may have a small piece of prostate removed.
  • Participants must practice effective birth control before and during the study treatment and for 1 month after the last vaccine booster.
  • Participants will have a medical history, physical exam, and blood and liver tests. They will be asked about how they perform daily activities.
  • Participants will have a magnetic resonance imaging (MRI) scan of the prostate. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the scanner.
  • Participants will be injected with the vaccine, most likely in the leg. They will be injected with the vaccine booster 3 times over several weeks.
  • At each booster visit, participants will have a medical history, physical exam, and blood and liver tests.
  • Participants will have another MRI. Then they will have surgery to remove their prostate.
  • Participants will have 2 follow-up visits during the year after surgery. They will have a medical history, physical exam, and blood test.
Read the detailed description

Background

  • Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and follows lung cancer as the leading cause of cancer death.
  • Vaccine strategies represent a novel therapeutic approach in the treatment for prostate cancer. One potential target for a prostate cancer vaccine is prostatic specific antigen (PSA), due to its restricted expression on prostate cancer and normal prostatic epithelial cells.
  • A neoadjuvant approach may be of potential benefit providing prolonged protection via the patient s immune system against future recurrence.
  • PROSTVAC is a vaccine that induces strong immune responses, has shown promising evidence of activity in a randomized phase II study (8.5 month improvement in median overall survival) and is currently in phase III clinical testing.
  • This vaccine has been tested in locally recurrent prostate cancer with substantial inflammatory infiltrates within the prostate seen following subcutaneous and intraprostatic injection.

Objectives

-The primary objective is to evaluate the post vaccine immunologic cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) cell infiltrate response of a neoadjuvant vaccine strategy in prostatectomy specimens in patients who plan to undergo radical prostatectomy.

Eligibility

  • Patients must have biopsy proven prostate cancer and are surgical candidates for radical prostatectomy
  • Must be of sufficient good health to be surgical candidates for radical prostatectomy and have elected radical prostatectomy for management of their prostate cancer
  • Granulocyte count is greater than or equal to 1,500/mm(3), Platelet is greater than or equal to 50,000/mm(3), hemoglobin (Hgb) is greater than or equal to 8 g/dL, Bilirubin < 1.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5x upper limit of normal (ULN), Creatinine is less than or equal to 1.5 X ULN
  • Pre-intervention biopsy tissue must be available either from outside institution or repeat biopsy

Design

  • This study will utilize rV-PSA(L155)-TRICOM (PROSTVAC-V) as a priming vaccination followed by monthly boosting with rF-PSA (L155)-TRICOM (PROSTVAC-F) for 3 months.
  • Patients will undergo radical prostatectomy after 4 months of treatment with PROSTVAC-V/F.
  • The maximum accrual to the trial will be 27 patients.
Being tested
PROSTVAC-V/TRICOM, PROSTVAC-F/TRICOM
Keywords
Surgery, Neoadjuvant, CD8 Cell Infiltrate Response, CD4 Cell Infiltrate Response, Vaccine
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PROSTVAC-V/TRICOMBiological

    A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules.

  • PROSTVAC-F/TRICOMBiological

    A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.

Study groups in NCT02153918
Study groupRoleWhat they receive
Vaccine Plus Booster ShotsExperimentalPROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC
Receives: Biological: PROSTVAC-V/TRICOM; Biological: PROSTVAC-F/TRICOM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes From Baseline to After Surgery of Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Infiltrates

    Immunologic CD4 and CD8 cell infiltrate response of a neoadjuvant prime/boost vaccine strategy in prostatectomy specimens. Prostate biopsy specimens are collected and stained for CD4 and CD8 cells. Quantification is reported as the number of stained cells per micron squared of surface area. Change will be noted by utilizing computer automated staining analysis. Density of cell infiltrate will be calculated and the pre and post vaccine values will be compared to determine response to vaccine.

    Measured: Baseline (pre vaccination) and approximately week 10

Secondary outcomes (5)

  1. Count of Participants With Change in Peripheral Prostatic Specific Antigen (PSA)-Specific T Cell Responses

    Change in peripheral prostatic specific antigen (PSA)-specific T cells will be assessed by the enzyme-linked immunospot (ELISPOT) assay. A change of >250 cluster of differentiation 4 (CD4) or cluster of differentiation 8 (CD8) cells producing cytokine or positive for cluster of differentiation 107a (CD107a) in response to PSA post vaccination relative to baseline will be considered evidence of an immunologic response to the vaccine. The number of subjects developing positive PSA-Specific T cell responses with vaccination will be reported.

    Measured: Baseline (pre vaccination) and week 10

  2. Intraprostatic Treg Cell Infiltration With Cluster of Differentiation 4 (CD4)+Forkhead Box P3 (FOX-P3) Staining

    Prostate biopsy samples collected at baseline and at surgery after last dose of vaccine will be stained for analysis of immune cell infiltrate. Quantification will be reported as number of stained cells per micron squared of surface area.

    Measured: Baseline (pre vaccination) and post surgery after last dose of vaccine, approximately week 10

  3. Prostatic Specific Antigen (PSA) Changes Secondary to Vaccination

    A change in PSA secondary to vaccination is defined as an increase or decrease in PSA value beyond the baseline level. PSA levels of 4.0 ng/ml and lower are considered normal.

    Measured: Baseline (pre vaccination) and approximately week 10

  4. Magnetic Resonance Imaging (MRI) Changes Secondary to Vaccination

    MRI of the prostate was performed for changes in imaging characteristics of prostate cancer pre and post vaccination. MRI changes secondary to vaccination is defined as increase or decrease in the size of lesions from baseline (pre-vaccine) measurements.

    Measured: Baseline (pre vaccination) and approximately week 10

  5. Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)

    Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

    Measured: Date treatment consent signed to date off study, approximately 33 months and 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2014 (estimated)
  2. Study start31 May 2014
  3. Primary completion28 Jul 2017
  4. Study completion16 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02153918
Sponsor's protocol ID
140112
Other IDs
14-C-0112
Status last verified
Sep 2018
First submitted
31 May 2014
Last updated
12 Oct 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • DiPaola RS, Plante M, Kaufman H, Petrylak DP, Israeli R, Lattime E, Manson K, Schuetz T. A phase I trial of pox PSA vaccines (PROSTVAC-VF) with B7-1, ICAM-1, and LFA-3 co-stimulatory molecules (TRICOM) in patients with prostate cancer. J Transl Med. 2006 Jan 3;4:1. doi: 10.1186/1479-5876-4-1.

    PubMed 16390546

  • Gulley JL, Heery CR, Madan RA, Walter BA, Merino MJ, Dahut WL, Tsang KY, Schlom J, Pinto PA. Phase I study of intraprostatic vaccine administration in men with locally recurrent or progressive prostate cancer. Cancer Immunol Immunother. 2013 Sep;62(9):1521-31. doi: 10.1007/s00262-013-1448-0. Epub 2013 Jul 9.

    PubMed 23836412

  • Kantoff PW, Schuetz TJ, Blumenstein BA, Glode LM, Bilhartz DL, Wyand M, Manson K, Panicali DL, Laus R, Schlom J, Dahut WL, Arlen PM, Gulley JL, Godfrey WR. Overall survival analysis of a phase II randomized controlled trial of a Poxviral-based PSA-targeted immunotherapy in metastatic castration-resistant prostate cancer. J Clin Oncol. 2010 Mar 1;28(7):1099-105. doi: 10.1200/JCO.2009.25.0597. Epub 2010 Jan 25.

    PubMed 20100959

  • Abdul Sater H, Marte JL, Donahue RN, Walter-Rodriguez B, Heery CR, Steinberg SM, Cordes LM, Chun G, Karzai F, Bilusic M, Harmon SA, Turkbey IB, Choyke PL, Schlom J, Dahut WL, Madan RA, Pinto PA, Gulley JL. Neoadjuvant PROSTVAC prior to radical prostatectomy enhances T-cell infiltration into the tumor immune microenvironment in men with prostate cancer. J Immunother Cancer. 2020 Mar;8(1):e000655. doi: 10.1136/jitc-2020-000655.

    PubMed 32269146

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PROSTVAC-V/TRICOM and PROSTVAC-F/TRICOM in people with Prostate Cancer and Prostatic Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes From Baseline to After Surgery of Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Infiltrates (time frame: Baseline (pre vaccination) and approximately week 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02153918, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.

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