Poly-ICLC for Prostate Cancer

Phase 2

Recruiting

Research Sponsored by Ashutosh Kumar Tewari

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing the effects of a drug called Poly-ICLC (Hiltonol®) versus no treatment on prostate cancer patients who are being monitored closely but not actively treated.

Who is the study for?

This trial is for men with prostate cancer who are being closely monitored (active surveillance) instead of immediate treatment. Specific eligibility details aren't provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

What is being tested?

The study is testing Hiltonol® (Poly-ICLC), which will be given as shots into a muscle or directly into the tumor. It's a phase II pilot study to see if this treatment can benefit those on active surveillance compared to no treatment at all.

What are the potential side effects?

While specific side effects for Poly-ICLC are not listed here, similar treatments may cause flu-like symptoms, injection site reactions, fatigue, and possibly mild fever.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of subjects without Gleason group downgrade after treatment

Proportion of subjects without Gleason group upgrade after treatment

Secondary study objectives

Number of subjects who experience adverse events per NCI-CTCAE 5.0

Number of subjects who receive prostate cancer treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Hiltonol (Poly-ICLC)Active Control2 Interventions

Enrolled study subjects will receive paired intramuscular (IM) and intertumoral. (IT) injections of the drug Poly-ICLC (Hiltonol®) as follows: Paired 1.5 mg IM (week 1), 1 mg IT once (week 2), followed by paired 1.5 mg IM weekly from weeks 3-through10, and at weeks 14, 18, 22, 26, 30, 34, 38, 42 and 46 with a 4-week rest period between IM injections.

Group II: Control (Standard of Care)Active Control1 Intervention

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