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CompletedNCT02326805Updated Jul 19, 2023Results posted

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

A Phase 2 interventional study of Laboratory Biomarker Analysis and Placebo Administration in Stage I Prostate Adenocarcinoma AJCC v7 and Stage II Prostate Adenocarcinoma AJCC v7, sponsored by National Cancer Institute (NCI). Completed at 7 sites in United States. Open to male participants. Per ClinicalTrials.gov, last updated 2023-07-19.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
154
Allocation
Randomized
Sex
Male
01

Study 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.

Read the detailed description

PRIMARY OBJECTIVES:

I. 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:

I. 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.

X. 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.

02

Conditions studied

  • Stage I Prostate Adenocarcinoma AJCC v7
  • Stage II Prostate Adenocarcinoma AJCC v7
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 154 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
    • 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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
154 participants (actual)

Study arms

  • Experimental
    Arm I (rilimogene-galvacirepvec)

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

    Other: Laboratory Biomarker Analysis · Biological: Rilimogene Galvacirepvec

  • Placebo comparator
    Arm II (placebo)

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

    Other: Laboratory Biomarker Analysis · Other: Placebo Administration

Interventions

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • OtherPlacebo Administration

    Given SC

  • BiologicalRilimogene Galvacirepvec

    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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: Baseline to up to 14 days after the last dose

Secondary outcomes

  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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: Up to 14 days after the last dose

  9. Size of Dominant MRI Lesion

    The size of dominant MRI lesion.

    Time frame: 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

    Time frame: 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

    Time frame: Baseline to up to 14 days after the last dose

  12. Immunologic Effects on the Target Organ Using Multiplex Immunofluorescence

    Time frame: 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.

    Time frame: Baseline to up to 6 months post-intervention

07

Results

Posted Nov 2, 2021

Participant flow

Participant flow — Overall Study
MilestoneArm I (Rilimogene-galvacirepvec)Arm II (Placebo)
Started10648
Completed10347
Not completed31

Outcome measures

PrimaryChange 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.

Time frame:
Baseline to up to 14 days after the last dose
Reported as:
Mean · number of positive cells per mm^2
Change in CD8+ Positive Cells in the Stroma Adjacent to Tumor and Within the Malignant Portion of the Prostate Biopsies
number of positive cells per mm^2Arm I (Rilimogene-galvacirepvec)Arm II (Placebo)
Change in CD8+ Positive Cells in the Stroma Adjacent to Tumor and Within the Malignant Portion of the Prostate Biopsies12.2 ± 151.4-6.9 ± 154
PrimaryChange 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.

Time frame:
Baseline to up to 14 days after the last dose
Reported as:
Mean · number of positive cells per mm^2
Change in CD4+ Positive Cells in the Stroma Adjacent to Tumor and Within the Malignant Portion of the Prostate Biopsies
number of positive cells per mm^2Arm I (Rilimogene-galvacirepvec)Arm II (Placebo)
Change in CD4+ Positive Cells in the Stroma Adjacent to Tumor and Within the Malignant Portion of the Prostate Biopsies4.6 ± 166.75.8 ± 261.1
SecondaryChange 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

Time frame:
Baseline to 6 months post-intervention

No measurements were reported for this outcome.

SecondaryChange in Prostate-specific Antigen (PSA)

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

Time frame:
Baseline to 6 months post-intervention
Reported as:
Mean · ng/ml
Change in Prostate-specific Antigen (PSA)
ng/mlArm I (Rilimogene-galvacirepvec)Arm II (Placebo)
Change in Prostate-specific Antigen (PSA)0.26 ± 2.36-0.66 ± 3.49
SecondaryChange 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

Time frame:
Baseline to up to 14 days after the last dose
Reported as:
Mean · number of positive cells per mm^2
Change in CD8+ Positive Cells in the Benign Portion of the Prostate Biopsies
number of positive cells per mm^2Arm I (Rilimogene-galvacirepvec)Arm II (Placebo)
Change in CD8+ Positive Cells in the Benign Portion of the Prostate Biopsies7.22 ± 202.9445.25 ± 198.25
SecondaryChange 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

Time frame:
Baseline to up to 14 days after the last dose
Reported as:
Mean · number of positive cells per mm^2
Change in CD4+ Positive Cells in the Benign Portion of the Prostate Biopsies
number of positive cells per mm^2Arm I (Rilimogene-galvacirepvec)Arm II (Placebo)
Change in CD4+ Positive Cells in the Benign Portion of the Prostate Biopsies73.41 ± 287.74-19.75 ± 206.59
SecondaryChange 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

Time frame:
Baseline to up to 14 days after the last dose

No measurements were reported for this outcome.

SecondaryTumor 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.

Time frame:
Baseline to up to 14 days after the last dose
Reported as:
Count of participants · Participants
Tumor Grade Progression
ParticipantsArm I (Rilimogene-galvacirepvec)Arm II (Placebo)
Tumor Grade Progression86
SecondaryChange in Tumor Extent

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

Time frame:
Baseline to up to 14 days after the last dose
Reported as:
Mean · percentage of total cores
Change in Tumor Extent
percentage of total coresArm I (Rilimogene-galvacirepvec)Arm II (Placebo)
Change in Tumor Extent-1.7 ± 16.11.6 ± 15.2
SecondaryProportion of Men With no Cancer in the Post-intervention Biopsy

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

Time frame:
Up to 14 days after the last dose
Reported as:
Count of participants · Participants
Proportion of Men With no Cancer in the Post-intervention Biopsy
ParticipantsArm I (Rilimogene-galvacirepvec)Arm II (Placebo)
Proportion of Men With no Cancer in the Post-intervention Biopsy258
SecondarySize of Dominant MRI Lesion

The size of dominant MRI lesion.

Time frame:
Up to 14 days after the last dose

No measurements were reported for this outcome.

SecondaryChange in Circulating 15-Mer PSA-specific T Cells

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

Time frame:
Baseline to up to 14 days after the last dose

No measurements were reported for this outcome.

SecondaryChange in Soluble Antibodies to Tumor-associated Antigens

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

Time frame:
Baseline to up to 14 days after the last dose

No measurements were reported for this outcome.

SecondaryImmunologic Effects on the Target Organ Using Multiplex Immunofluorescence
Time frame:
Up to 14 days after the last dose

No measurements were reported for this outcome.

SecondaryChange 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.

Time frame:
Baseline to up to 6 months post-intervention
Reported as:
Mean · score on a scale
Change in International Prostate Symptom Score
score on a scaleArm I (Rilimogene-galvacirepvec)Arm II (Placebo)
Change in International Prostate Symptom Score-0.12 ± 4.670.87 ± 3.57

Adverse events

Collected over 30 days after the last study dose was given. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm I (Rilimogene-galvacirepvec)1/106 (0.9%)1/106 (0.9%)103/106 (97.2%)
Arm II (Placebo)0/48 (0%)0/48 (0%)48/48 (100%)
Most frequent serious events
Most frequent serious events
EventArm I (Rilimogene-galvacirepvec)Arm II (Placebo)
FallInjury, poisoning and procedural complications1/1060/48
Most frequent other events
Showing 10 of 17
Most frequent other events
EventArm I (Rilimogene-galvacirepvec)Arm II (Placebo)
Injection site reactionGeneral disorders95/10645/48
Flu like syndromesHepatobiliary disorders63/10630/48
FatigueGeneral disorders43/10614/48
HeadacheNervous system disorders23/1069/48
FeverGeneral disorders17/1066/48
DiarrheaGastrointestinal disorders10/1066/48
Upper respiratory infectionInfections and infestations10/1064/48
DizzinessNervous system disorders10/1060/48
NauseaGastrointestinal disorders9/1062/48
White blood cell decreasedInvestigations1/1064/48

Baseline characteristics

Age, Continuous
Age, Continuous(years)Arm I (Rilimogene-galvacirepvec)Arm II (Placebo)Total
Mean65 ± 764 ± 864 ± 8
Sex: Female, Male
Sex: Female, Male(Participants)Arm I (Rilimogene-galvacirepvec)Arm II (Placebo)Total
Female000
Male10648154
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm I (Rilimogene-galvacirepvec)Arm II (Placebo)Total
Hispanic or Latino415
Not Hispanic or Latino9845143
Unknown or Not Reported426
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm I (Rilimogene-galvacirepvec)Arm II (Placebo)Total
American Indian or Alaska Native000
Asian303
Native Hawaiian or Other Pacific Islander101
Black or African American7512
White9143134
More than one race000
Unknown or Not Reported404
Region of Enrollment
Region of Enrollment(participants)Arm I (Rilimogene-galvacirepvec)Arm II (Placebo)Total
United States10648154
08

Study locations

7 sites
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
  • Cedars Sinai Medical Center
    Los Angeles, California 90048, United States
  • Hoag Memorial Hospital
    Newport Beach, California 92663, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
    Orange, California 92868, United States
  • UC San Diego Medical Center - Hillcrest
    San Diego, California 92103, United States
  • Johns Hopkins Bayview Medical Center
    Baltimore, Maryland 21224, United States
  • NCI - Center for Cancer Research
    Bethesda, Maryland 20892, United States
09

References and documents

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 ↗

Study documents

  • Protocol, analysis plan and consent form · Sep 26, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02326805
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Dec 30, 2014
Start date
Jun 3, 2015
Primary completion
Nov 30, 2018
Completion
Jul 20, 2022
Results posted
Nov 2, 2021
Last update
Jul 19, 2023

Study contacts

John K Parsons
principal investigator · The University of Arizona Medical Center-University Campus

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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