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Stage I Prostate Adenocarcinoma AJCC v7Phase 2NCT02326805

PROSTVAC (PSA-TRICOM) in Preventing Disease Progression in Patients With Localized Prostate Cancer Undergoing Active Surveillance

A Phase 2 study testing Laboratory Biomarker Analysis and Rilimogene Galvacirepvec in people with Stage I Prostate Adenocarcinoma AJCC v7 and Stage II Prostate Adenocarcinoma AJCC v7, run by National Cancer Institute (NCI) at 7 sites 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

This randomized phase II trial studies how well PROSTVAC (prostate-specific antigen [PSA]-TRICOM) works in preventing disease progression in patients with prostate cancer undergoing active surveillance. Read more about this study

Who is it for?
Any age, men only
What is being tested?
Laboratory Biomarker Analysis and Rilimogene Galvacirepvec
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
154 participants
Where
7 sitesUnited States
Study dates
3 Jun 2015to 20 Jul 2022
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 Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Biopsy-proven (consisting of >= 10 tissue cores) adenocarcinoma of the prostate with cancer present in at least one biopsy core, either random or targeted, in the most recent biopsy
  • All prior biopsies must meet the following: =< 50% of the total number of random biopsy cores positive for cancer
  • Gleason score =< (3+4)
  • Clinical stage =< T2a by digital rectal exam (DRE)
  • Biopsies performed at outside institutions should have Gleason score confirmed at the study site by a genitourinary (GU) pathologist to ensure eligibility
  • Pre-intervention biopsy tissue (most proximal to enrollment) with sufficient tumor tissue to cut 5-10 unstained slides confirmed to be available upon request
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  • Screening serum PSA < 20 ng/mL; for men treated with 5-alpha-reductase inhibitors (e.g., finasteride, dutasteride), PSA needs to be < 10 ng/mL
  • Neutrophil count >= 1,200/mm^3 (>= 1.2 k/uL)
  • Stable platelet count >= 75,000/mm^3 (>= 75 k/uL)
  • Bilirubin =< 1.5 mg/dL (or =< 3.0 mg/dL for patients with Gilbert's syndrome)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN)
  • Serum creatinine =< 1.5 x ULN
  • Karnofsky >= 70%
  • Must agree to use medically acceptable barrier and/or chemical method of contraception while on study and for at least one month following the last vaccine injection; should a participant's partner become pregnant or suspect she is pregnant while the participant is participating in this study, the study physician should be informed immediately; in the event a participant's partner becomes pregnant, the study sponsor may request additional information regarding the course of the pregnancy and if the pregnancy is carried to term, the birth of the child (i.e., the outcome of the pregnancy)
  • Ability to understand and the willingness to sign a written informed consent document
  • No planned prostate biopsies during the intervention until after the post-intervention biopsy
  • Men on stable doses of 5-alpha reductase inhibitors are eligible as long as there is no planned dose change while on study

Who cannot join

  • Have had prior treatment for prostate cancer by surgery, irradiation, local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or androgen-deprivation therapy
  • Patients who have prostate cancer with distant metastases
  • Have undergone treatment of hormone therapy, immunotherapy, chemotherapy and/or radiation for any malignancies within the past 2 years
  • Uncontrolled intermittent illnesses or medical conditions which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient; such illnesses/conditions may include, but are not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Positive for human immunodeficiency virus (HIV) or active infections for hepatitis B, and/or hepatitis C, based on medical history
  • Prior solid organ or bone marrow transplant
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  • Immunodeficiency or splenectomy
  • Chronic immunosuppressive therapy within 30 days of screening
  • Inflammatory eye disease requiring steroid treatment within 28 days of screening
  • Chronic administration (defined as daily or every other day for continued use > 14 days) of systemic corticosteroids within 28 days of the first planned dose of PROSTVAC-V/F; use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed
  • History of or active autoimmune disease including but not limited to autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus erythematosus, Sjogren's syndrome, scleroderma, myasthenia gravis, Goodpasture's syndrome; persons with vitiligo are not excluded; Persons with well-controlled autoimmune endocrinopathies, e.g., diabetes mellitus, Graves' disease, Hashimoto's thyroiditis, Addison's disease are not excluded; persons with well-controlled rheumatoid arthritis, psoriatic arthritis and polymyalgia rheumatica are not excluded
  • Known allergy to eggs, egg products
  • Prior or concurrent eczema or other eczemoid skin disorders or active skin condition (acute, chronic, or exfoliative) that disrupts the epidermis; persons with psoriasis are not excluded except in cases of:
  • any active lesion
  • any active lesion in the previous 6 months that required treatment, either systemic or topical
  • any prior episode, at any time, extensive enough or severe enough as to require systemic treatment
  • Previous adverse reactions to smallpox vaccination
  • Unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the day 1 vaccination or until the vaccination site heals completely: (a) children =< 3 years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders, (d) individuals with other acute, chronic, or exfoliative skin condition, or (e) immunocompromised or immunosuppressed persons (by disease or therapy)
  • Participants may not be receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition of PROSTVAC

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

  • NCI - Center for Cancer Research

    Bethesda, Maryland, 20892

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Hoag Memorial Hospital

    Newport Beach, California, 92663

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • UC San Diego Medical Center - Hillcrest

    San Diego, California, 92103

Other trials in United States

About this study

Official title: Phase II Randomized, Placebo-Controlled Trial of PROSTVAC (PSA-TRICOM) in Patients With Clinically Localized Prostate Cancer Undergoing Active Surveillance

This randomized phase II trial studies how well PROSTVAC (prostate-specific antigen [PSA]-TRICOM) works in preventing disease progression in patients with prostate cancer undergoing active surveillance. Vaccines made from a person's tumor cells may help the body build an effective immune response to kill tumor cells that express PSA.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the effect of rilimogene-galvacirepvec (PROSTVAC) on the change (from pre to post-intervention) in CD8+ positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies.

II. To determine the effect of PROSTVAC on the change in CD4+ positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies.

SECONDARY OBJECTIVES:

  1. To assess the effect of PROSTVAC on PD-L1 positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies.

II. To assess the correlation between the change in CD8+ and the change in PSA. III. To assess the effect of PROSTVAC on CD8+, CD4+, and PD-L1 positive cells in the benign portion of the prostate biopsies.

IV. To assess the effect of PROSTVAC on the change in PSA. V. To assess the effect of PROSTVAC on tumor grade (Gleason score). VI. To assess the effect of PROSTVAC on tumor extent (percent of positive random biopsy cores).

VII. To compare the proportion of men on the two study arms with no cancer on post-intervention biopsy.

VIII. To assess the effect of PROSTVAC on the size of the dominant lesion on magnetic resonance imaging (MRI) (largest histopathologically confirmed lesion) in the subgroup of patients with MRIs pre and postintervention.

IX. To assess the effect of PROSTVAC on circulating 15-Mer PSA-specific, MUC-1 and Brachyury-specific T cells.

  1. To assess the effect of PROSTVAC on soluble antibodies to tumor-associated antigens.

XI. To assess the immunologic effects of PROSTVAC in prostate tissue using multiplex immunofluorescence.

XII. To assess the safety and feasibility of PROSTVAC in the active surveillance population.

XIII. To assess the effect of PROSTVAC on lower urinary tract symptoms (LUTS) in the active surveillance population.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive rilimogene-galvacirepvec subcutaneously (SC) at baseline and on days 14, 28, 56, 84, 112, and 140.

ARM II: Patients receive placebo SC at baseline and on days 14, 28, 56, 84, 112, and 140.

After completion of study treatment, patients are followed up for 30 days and then at 6 months.

Being tested
Laboratory Biomarker Analysis, Placebo Administration, Rilimogene Galvacirepvec

What participants receive

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

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Placebo AdministrationOther

    Given SC

  • Rilimogene GalvacirepvecBiological

    Also called PROSTVAC, Prostvac-V, Recombinant Vaccinia-PSA(L155)-TRICOM Vaccine, Recombinant Vaccinia-PSA(L155)/TRICOM

    Given SC

Study groups in NCT02326805
Study groupRoleWhat they receive
Arm I (rilimogene-galvacirepvec)ExperimentalPatients receive rilimogene-galvacirepvec SC at baseline and on days 14, 28, 56, 84, 112, and 140.
Receives: Other: Laboratory Biomarker Analysis; Biological: Rilimogene Galvacirepvec
Arm II (placebo)Placebo comparatorPatients receive placebo SC at baseline and on days 14, 28, 56, 84, 112, and 140.
Receives: Other: Laboratory Biomarker Analysis; Other: Placebo Administration

What is being measured

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

  1. Change in CD8+ Positive Cells in the Stroma Adjacent to Tumor and Within the Malignant Portion of the Prostate Biopsies

    change (from pre to post-intervention) in CD8+ positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies.

    Measured: Baseline to up to 14 days after the last dose

  2. Change in CD4+ Positive Cells in the Stroma Adjacent to Tumor and Within the Malignant Portion of the Prostate Biopsies

    change (from pre to post-intervention) in CD4+ positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies.

    Measured: Baseline to up to 14 days after the last dose

Secondary outcomes (13)

  1. Change in PD-L1 Positive Cells in the Stroma Adjacent to Tumor and Within the Malignant Portion of the Prostate Biopsies

    Change (from pre to post-intervention) in PD-L1 positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies

    Measured: Baseline to 6 months post-intervention

  2. Change in Prostate-specific Antigen (PSA)

    Change (from baseline to 6 months post-intervention) in prostate-specific antigen (PSA)

    Measured: Baseline to 6 months post-intervention

  3. Change in CD8+ Positive Cells in the Benign Portion of the Prostate Biopsies

    Change (from pre to post-intervention) in CD8+ positive cells in the benign portion of the prostate biopsies

    Measured: Baseline to up to 14 days after the last dose

  4. Change in CD4+ Positive Cells in the Benign Portion of the Prostate Biopsies

    Change (from pre to post-intervention) in CD4+ positive cells in the benign portion of the prostate biopsies

    Measured: Baseline to up to 14 days after the last dose

  5. Change in PD-L1 Positive Cells in the Benign Portion of the Prostate Biopsies

    Change (from pre to post-intervention) in PD-L1 positive cells in the benign portion of the prostate biopsies

    Measured: Baseline to up to 14 days after the last dose

  6. Tumor Grade Progression

    Assessed by the proportion of men with an increase in Gleason score to >= 4+3 from baseline to post-intervention biopsy. The Gleason score is determined by adding the two most common grades. The Gleason score usually ranges from 6 to 10. Higher numbers indicate a faster growing cancer that is more likely to spread.

    Measured: Baseline to up to 14 days after the last dose

  7. Change in Tumor Extent

    Assessed by change (from pre to post-intervention) in percent positive random cores

    Measured: Baseline to up to 14 days after the last dose

  8. Proportion of Men With no Cancer in the Post-intervention Biopsy

    Assessed by the proportion of patients with no cancer on the post-intervention biopsy

    Measured: Up to 14 days after the last dose

  9. Size of Dominant MRI Lesion

    The size of dominant MRI lesion.

    Measured: Up to 14 days after the last dose

  10. Change in Circulating 15-Mer PSA-specific T Cells

    Change (from pre to post-intervention) in circulating 15-Mer PSA-specific T cells

    Measured: Baseline to up to 14 days after the last dose

  11. Change in Soluble Antibodies to Tumor-associated Antigens

    Change (from pre to post-intervention) in soluble antibodies to tumor-associated antigens

    Measured: Baseline to up to 14 days after the last dose

  12. Immunologic Effects on the Target Organ Using Multiplex Immunofluorescence

    Measured: Up to 14 days after the last dose

  13. Change in International Prostate Symptom Score

    Change (from baseline to 6 months post-intervention) in International Prostate Symptom Score (IPSS). The IPSS score ranges from 0-35. Higher scores mean a worse symptom.

    Measured: Baseline to up to 6 months post-intervention

Timeline

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

  1. First posted30 Dec 2014 (estimated)
  2. Study start3 Jun 2015
  3. Primary completion30 Nov 2018
  4. Study completion20 Jul 2022

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02326805
Sponsor's protocol ID
NCI-2014-02556
Other IDs
NCI-2014-02556, AZ027, HHSN2612012000311, N01-CN-2012-00031, 1410547210, UAZ2014-03-01, N01CN00031, P30CA023074
Status last verified
Jun 2023
First submitted
24 Dec 2014
Last updated
19 Jul 2023
Data monitoring committee
Yes

Publications

  • Parsons JK, Pinto PA, Pavlovich CP, Uchio E, Kim HL, Nguyen MN, Gulley JL, Jamieson C, Hsu P, Wojtowicz M, Parnes H, Schlom J, Dahut WL, Madan RA, Donahue RN, Chow HS. A Randomized, Double-blind, Phase II Trial of PSA-TRICOM (PROSTVAC) in Patients with Localized Prostate Cancer: The Immunotherapy to Prevent Progression on Active Surveillance Study. Eur Urol Focus. 2018 Sep;4(5):636-638. doi: 10.1016/j.euf.2018.08.016. Epub 2018 Sep 7.

    PubMed 30197041

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Laboratory Biomarker Analysis and Rilimogene Galvacirepvec in people with Stage I Prostate Adenocarcinoma AJCC v7 and Stage II Prostate Adenocarcinoma AJCC v7, run by National Cancer Institute (NCI) at 7 sites 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 17 inclusion and 20 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 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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. Some participants in this study may receive a placebo. 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 2 Nov 2021). 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?

Change in CD8+ Positive Cells in the Stroma Adjacent to Tumor and Within the Malignant Portion of the Prostate Biopsies (time frame: Baseline to up to 14 days after the last dose). The study lists 2 primary outcomes in all. 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 NCT02326805, which also lists 1 linked publication.

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 19 Jul 2023.

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