Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance

Conditions

• Prostate Cancer Patients on Active Surveillance

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Poly-ICLC intramuscular (IM) injection — DRUG
  1.5 mg IM (week 1), 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.
• Poly-ICLC, Intertumoral (IT) injection — DRUG
  1 mg IT once (week 2)

Study Details

This is a partially blinded randomized controlled phase II pilot study comparing Poly-ICLC (Hiltonol®) treatment vs no treatment, for prostate cancer participants on active surveillance.

Key Dates

Start date

Jan 16, 2024

Status verified

Mar 2024

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

114 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Hiltonol (Poly-ICLC)
  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.
• No Intervention: Control (Standard of Care)

Primary Outcome Measure

Proportion of subjects without Gleason group upgrade after treatment [ Time Frame: at 12 months ]

Central Contacts

• Monali Fatterpekar, PhD
  212-241-0751
  [email protected]
• Cristina Pasat-karasik, RN
  [email protected]

Locations (1)

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