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Cancer Vaccine

Rilimogene Galvacirepvec for Prostate Cancer

Phase 2

Waitlist Available

Led By John K Parsons

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 months post-intervention

Awards & highlights

Study Summary

This trial is studying if a vaccine made from a person's tumor cells can help prevent disease progression in patients with prostate cancer who are undergoing active surveillance.

Eligible Conditions

Prostate Adenocarcinoma
Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6 months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

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

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

Change in Circulating 15-Mer PSA-specific T Cells

+10 more

Side effects data

From 2022 Phase 2 trial • 154 Patients • NCT02326805

90%

Injection site reaction

59%

Flu like syndromes

41%

Fatigue

22%

Headache

16%

Fever

Diarrhea

Dizziness

Upper respiratory infection

Nausea

Myalgia

Back pain

Bruising

Sore throat

Skin and subcutaneous tissue disorders - other

Renal and urinary disorders - others

Rash maculo-papular

Fall

White blood cell decreased

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Rilimogene-galvacirepvec)

Arm II (Placebo)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (rilimogene-galvacirepvec)Experimental Treatment2 Interventions

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

Group II: Arm II (placebo)Placebo Group2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rilimogene Galvacirepvec

2015

Completed Phase 2

~160

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,932,999 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,173 Patients Enrolled for Prostate Cancer

John K ParsonsPrincipal InvestigatorThe University of Arizona Medical Center-University Campus

1 Previous Clinical Trials

40 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what geographical areas is this investigation being conducted?

"Currently, this medical trial is being hosted in 7 distinct sites. These include San Diego, Newport Beach and Bethesda with other locales scattered about the US for convenience of potential participants. To reduce travel demands, it may be best to select a clinic closest to your residence if you choose to join the study."

Answered by AI

Are there any adverse effects associated with the application of Rilimogene Galvacirepvec?

"Based on the available evidence, our team at Power assigned Rilimogene Galvacirepvec a score of 2. This reflects that while there is some data to support safety, there are no studies demonstrating efficacy yet."

Answered by AI

Are there still opportunities for individuals to join this research endeavor?

"Clinicaltrials.gov reveals that, while this trial was published on June 3rd 2015 and last edited October 6th 2021, it is not currently recruiting participants. However, there are still 1,968 other trials which are presently seeking candidates."

Answered by AI

What results is the research team hoping to achieve through this clinical trial?

"This research's primary goal, evaluated from Baseline to 14 days after the final dosage is an examination of CD8+ positive cells in and around malignant prostate tissue. Secondary objectives include assessing adverse events through a Fisher’s exact test contrasted between experimental groups, as well as comparing PD-L1 Positive Cells via two-sample t tests with significance levels set at 5%. Lastly, CD8+ Positive Cell fluctuations will also be measured using two-sample t tests."

Answered by AI

Recent research and studies

European Urology FocusJournal

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

Parsons, J. Kellogg, Peter A. Pinto, Christian P. Pavlovich, Edward Uchio, Hyung L. Kim, Mikel N. Nguyen, James L. Gulley, et al.. 2018. “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”. European Urology Focus. Elsevier BV. doi:10.1016/j.euf.2018.08.016.

clinicaltrials.govStudy

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

2015. "PROSTVAC (PSA-TRICOM) in Preventing Disease Progression in Patients With Localized Prostate Cancer Undergoing Active Surveillance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02326805.