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

NCT02326805 | Completed Phase 2 Results DMC

• 8 other identifiers: NCI-2014-02556AZ027HHSN2612012000311N01-CN-2012-000311410547210UAZ2014-03-01N01CN00031P30CA023074
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 7

Brief 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. Vaccines made from a person's tumor cells may help the body build an effective immune response to kill tumor cells that express PSA.

Conditions

Stage I Prostate Adenocarcinoma AJCC v7; Stage II Prostate Adenocarcinoma AJCC v7

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline to up to 14 days after the last dose

• 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.

  Baseline to up to 14 days after the last dose

Secondary Outcomes (13)

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

  Baseline to 6 months post-intervention

• Change in Prostate-specific Antigen (PSA)

  Baseline to 6 months post-intervention

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

  Baseline to up to 14 days after the last dose

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

  Baseline to up to 14 days after the last dose

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

  Baseline to up to 14 days after the last dose

Study Arms (2)

Arm I (rilimogene-galvacirepvec)

EXPERIMENTAL

Patients receive rilimogene-galvacirepvec SC at baseline and on days 14, 28, 56, 84, 112, and 140.

Other: Laboratory Biomarker Analysis; Biological: Rilimogene Galvacirepvec

Arm II (placebo)

PLACEBO COMPARATOR

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

Other: Laboratory Biomarker Analysis; Other: Placebo Administration

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (rilimogene-galvacirepvec); Arm II (placebo)

Placebo Administration OTHER

Given SC

Arm II (placebo)

Rilimogene Galvacirepvec BIOLOGICAL

Given SC

Also known as: PROSTVAC, Prostvac-V, Recombinant Vaccinia-PSA(L155)-TRICOM Vaccine, Recombinant Vaccinia-PSA(L155)/TRICOM, Recombinant Vaccinia-PSA(L155)/TRICOM Vaccine, rVaccinia-Prostate-Specific Antigen/TRICOM Vaccine, rVaccinia-PSA(L155)-TRICOM Vaccine

Arm I (rilimogene-galvacirepvec)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (7)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Hoag Memorial Hospital

Newport Beach, California, 92663, United States

Location

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

UC San Diego Medical Center - Hillcrest

San Diego, California, 92103, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

NCI - Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• 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.

  PMID: 30197041 DERIVED

MeSH Terms

Interventions

PROSTVAC

Results Point of Contact

• Title: Sherry Chow, PhD
• Organization: University of Arizona

schow@azcc.arizona.edu

520-626-3358

Study Officials

• John K Parsons

  The University of Arizona Medical Center-University Campus

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2014
• First Posted: December 30, 2014
• Study Start: June 3, 2015
• Primary Completion: November 30, 2018
• Study Completion: July 20, 2022
• Last Updated: July 19, 2023
• Results First Posted: November 2, 2021

Record last verified: 2023-06

Locations

US (7)