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.
114 prostate cancer participants on active surveillance will be randomized 2:1 into treatment group, A or control group B respectively. Enrolled group A study participants will receive standard of care (SOC) plus intratumoral (IT) and intramuscular (IM) injections of study drug Poly-ICLC (Hiltonol®) as follows: Preconditioning: week 1: Paired IM Poly-ICLC, 1.5 mg to reduce tumor induced suppression Immune Priming: week 2, intratumor poly-ICLC 1.0 mg once, Boosting: Wk. 3 - 10: Paired 1.5 mg IM poly-ICLC weekly Maintenance: Month 3-12, Paired IM Poly-ICLC once a month Control patients in group B will receive standard care (SOC) for patients on Active Surveillance per AUS guidelines. Comparisons of safety and efficacy will be based on data from concurrently randomized participants. An independent data and safety monitoring board (DSMB) will actively monitor interim data for safety, efficacy or futility. Seventy-six (76) participants will receive treatment IT/IM Poly-ICLC (Hiltonol®) and 38 participants will serve as controls for a total of 114 study participants. Participants randomized to the treatment arm will receive standard of care (SOC) plus IT/IM Poly-ICLC (Hiltonol®). Participants in the control arm will receive SOC. This is a partially blind randomized controlled phase 2 trial conducted at the Mount Sinai Health System with 114 participants planned for enrollment. Eligible participants will be randomly assigned to one of the two groups. There will be an interim analysis conducted after half of the participants, 38 receiving Poly-ICLC and 19 controls receiving standard care have completed 1 year of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
114
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.
1 mg IT once (week 2)
Icahn School of Medicine at Mount Sinai (ISMMS)
New York, New York, United States
RECRUITINGProportion of subjects without Gleason group upgrade after treatment
Proportion of subjects without Gleason group upgrade after treatment with Poly-ICLC or control, as determined by histological examination of prostate biopsy at the one year time point.
Time frame: at 12 months
Proportion of subjects without Gleason group upgrade after treatment
Proportion of subjects without Gleason group upgrade after treatment with Poly-ICLC or control, as determined by histological examination of prostate biopsy at the three years time point.
Time frame: at 36 months
Proportion of subjects without Gleason group downgrade after treatment
Proportion of subjects with Gleason group downgrade after treatment with Poly-ICLC or control, as determined by histological examination of prostate biopsy at the one year time point.
Time frame: at 12 months
Proportion of subjects without Gleason group downgrade after treatment
Proportion of subjects with Gleason group downgrade after treatment with Poly-ICLC or control, as determined by histological examination of prostate biopsy at the 3 years time point.
Time frame: at 36 months
Number of subjects who experience adverse events per NCI-CTCAE 5.0
The number of subjects who experience adverse events, and/or dose-limiting toxicities (DLT) as defined by common criteria developed by the United States National Institutes of Health (NIH), National Cancer Institute and put forward as the Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0).
Time frame: At 12 months
Number of subjects who experience adverse events per NCI-CTCAE 5.0
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The number of subjects who experience adverse events, and/or dose-limiting toxicities (DLT) as defined by common criteria developed by the United States National Institutes of Health (NIH), National Cancer Institute and put forward as the Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0).
Time frame: At 36 months
Number of subjects who receive prostate cancer treatment
Number of subjects who receive prostate cancer treatment (e.g. surgery, radiation, hormone therapy)
Time frame: At 12 months
Number of subjects who receive prostate cancer treatment
Number of subjects who receive prostate cancer treatment (e.g. surgery, radiation, hormone therapy)
Time frame: At 36 months