Prostate Cancer Patients on Active SurveillancePhase 2NCT06343077
Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance
A Phase 2 study testing Poly-ICLC intramuscular (IM) injection and Poly-ICLC, Intertumoral (IT) injection in people with Prostate Cancer Patients on Active Surveillance, run by Ashutosh Kumar Tewari at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Patients on Active Surveillance
- What is being tested?
- Poly-ICLC intramuscular (IM) injection and Poly-ICLC, Intertumoral (IT) injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent and HIPAA authorization for release of personal health information.
- NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age > 18 years at the time of consent.
- ECOG Performance Status of 0-1 within 14 days prior to being registered for protocol therapy (Study Procedure Manual).
- Histologically confirmed adenocarcinoma of the prostate (with previous diagnostic tissue available for tumor marker analysis).
- • ISUP Grade 1(Gleason 3+3) and Grade 2 (Gleason 3+4) and Grade 1 (Gleason 3+3, with PSA≥10, or stage ≥ T2b)
Show all 35Show fewer
- Estimated life expectancy is ≥ 10 years
- Candidate for primary curative therapy (Radical prostatectomy or radiation) if cancer progresses.
- Tolerated previous transrectal ultrasound guided biopsy procedure under local anesthetic
- Uncomplicated previous TRUS biopsy procedure (i.e., no prior hospitalization due to sepsis, prostatic abscess or severe hemorrhage following TRUS prostate biopsy)
- Willing to undergo the intratumoral (IT) injection of the Poly-ICLC into the prostatic tumor as per the protocol
- No prior hormonal therapy with exception of with the exception of oral 5-alpha-reductase inhibitors (finasteride, dutasteride, etc.). Subjects should be off the medication ≥ 6 months from screening
- No prior radiation therapy (external beam or brachytherapy) to the pelvis or prostate.
- No clinically significant infections as judged by the treating investigator.
- No characteristics suggesting a potential higher risk of infection with intraprostatic injections:
- Recurrent urinary tract infections or history of prostatitis within 3 months prior to enrollment into the study.
- Urine analysis positive for nitrites and leucocyte esterase. Such subjects could be considered for the study after treatment and resolution of the infection.
- Active proctitis
- History of prostatic abscess
- Taking immunosuppressive medication including systemic corticosteroids
- Active hematologic malignancy
- No uncontrolled angina, congestive heart failure or MI within 6 months.
- Subjects with history of HIV (if CD4+ T cell counts are ≥350 cells/μL on established ART therapy), Hepatitis B (with viral load below limits of quantification) or Hepatitis C (who have completed a curative therapy and have a viral load below the limit of quantification) are eligible for this study.
- No treatment with any investigational agent for any medical condition within 28 days prior to being registered for protocol therapy.
- Patients with the potential for impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Contraception must be continued for at least 2 months following the last dose of poly-ICLC. While animal reproductive studies have been negative, the simulated viral infection and anti-proliferative activity of this experimental drug may theoretically affect the developing fetus or nursing infant.
- Adequate end organ function as determined by the following laboratory values:
- White blood cell count (WBC) ≥ 2.5 k/mm^3
- Absolute neutrophil count (ANC) ≥ 1.5 k/mm^3
- Hemoglobin (Hgb) ≥ 8.0 g/dL
- Platelets ≥ 100 k/mm^3
- Calculated creatinine clearance of > 60 cc/min using the Cockcroft-Gault formula:
- Males: [(140 - Age in years) × Actual Body Weight in kg]/[72 × Serum Creatinine (mg/dL)]
- Bilirubin ≤ 2.0 x ULN
- Aspartate aminotransferase (AST) ≤ 2.5 x ULN
- Alanine aminotransferase (ALT) ≤ 2.5 x ULN
Who cannot join
- Received local or systemic curative therapy for prostate cancer
- Subjects with neuroendocrine tumors
- ISUP Gleason Grade Group (>3), or Gleason 3+3 plus PSA ≤ 10 or Stage ≤T2a
- Evidence of locally advanced disease
- Subject has evidence of any other malignancy
- Allergy to any antibiotics, as IT administration requires prophylactic antibiotics.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cristina Pasat-karasik, RN contact
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai (ISMMS)
New York, New York, 10029
Monali Fatterpekar, PhD, monali.fatterpekar@mountsinai.org
Sujit S Nair, PhD, 212-241-7005, sujit.nair@mountsinai.org
About this study
Official title: Phase II Trial of In-Situ Autologous Vaccination With Intratumoral and Systemic Hiltonol® (Poly-ICLC) Administered to Prostate Cancer Patients on Active Surveillance
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.
Read the detailed description
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.
- Being tested
- Poly-ICLC intramuscular (IM) injection, Poly-ICLC, Intertumoral (IT) injection
- Keywords
- Prostate Cancer, Active Surveillance, Vaccination, Immunotherapy, drug POLY-ICLC, Gleason Grade 2 (Gleason 3+4), Gleason Grade 1 (Gleason 3+3)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly-ICLC intramuscular (IM) injectionDrug
Also called Hiltonol®, Polyinosinic-Polycytidylic acid stabilized with polylysine and carboxymethylcellulose
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) injectionDrug
Also called Hiltonol®, Polyinosinic-Polycytidylic acid stabilized with polylysine and carboxymethylcellulose
1 mg IT once (week 2)
| Study group | Role | What they receive |
|---|---|---|
| Hiltonol (Poly-ICLC) | Active comparator | 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. Receives: Drug: Poly-ICLC intramuscular (IM) injection; Drug: Poly-ICLC, Intertumoral (IT) injection |
| Control (Standard of Care) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 one year time point.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 36 months
Secondary outcomes (4)
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).
Measured: At 12 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).
Measured: 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)
Measured: 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)
Measured: At 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start16 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Patients on Active SurveillanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ashutosh Kumar Tewari
- Sponsor type
- University, hospital or other
- Collaborators
- Oncovir, Inc.
- Responsible party
- Sponsor-investigator, Ashutosh Kumar Tewari, Icahn School of Medicine at Mount Sinai
- Investigators
- Sujit S Nair, PhD, Study director, Assistant Professor and Director of GU Immunotherapy ResearchDimple Chakravarty, PhD, Study director, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343077
- Sponsor's protocol ID
- STUDY-22-00106
- Status last verified
- Mar 2024
- First submitted
- 27 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of In-Situ Autologous Vaccination With Intratumoral and Systemic Hiltonol® (Poly-ICLC) Administered to Prostate Cancer Patients on Active Surveillance
- ClinicalTrials.gov ID
- NCT06343077
- Acronym / sponsor ID
- STUDY-22-00106
- Keywords
- Prostate Cancer, Active Surveillance, Vaccination, Immunotherapy, drug POLY-ICLC, Gleason Grade 2 (Gleason 3+4), Gleason Grade 1 (Gleason 3+3)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Ashutosh Kumar TewariUniversity, hospital or other
- Collaborators
- Oncovir, Inc.
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hiltonol (Poly-ICLC) | Active comparator | Drug: Poly-ICLC intramuscular (IM) injection, Drug: Poly-ICLC, Intertumoral (IT) injectionEnrolled 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. |
| Control (Standard of Care) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- Written informed consent and HIPAA authorization for release of personal health information.
- NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age > 18 years at the time of consent.
- ECOG Performance Status of 0-1 within 14 days prior to being registered for protocol therapy (Study Procedure Manual).
- Histologically confirmed adenocarcinoma of the prostate (with previous diagnostic tissue available for tumor marker analysis).
Key exclusion criteria (6 listed)
- Received local or systemic curative therapy for prostate cancer
- Subjects with neuroendocrine tumors
- ISUP Gleason Grade Group (>3), or Gleason 3+3 plus PSA ≤ 10 or Stage ≤T2a
- Evidence of locally advanced disease
- Subject has evidence of any other malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Poly-ICLC intramuscular (IM) injectionAlso: Hiltonol®, Polyinosinic-Polycytidylic acid stabilized with polylysine and carboxymethylcellulose1.5 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. | Drug | Hiltonol (Poly-ICLC) |
| Poly-ICLC, Intertumoral (IT) injectionAlso: Hiltonol®, Polyinosinic-Polycytidylic acid stabilized with polylysine and carboxymethylcellulose1 mg IT once (week 2) | Drug | Hiltonol (Poly-ICLC) |
Primary outcome
Proportion of subjects without Gleason group upgrade after treatment
Time frame: at 12 months
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.
Proportion of subjects without Gleason group upgrade after treatment
Time frame: at 36 months
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.
Proportion of subjects without Gleason group downgrade after treatment
Time frame: at 12 months
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.
Proportion of subjects without Gleason group downgrade after treatment
Time frame: at 36 months
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.
4 secondary outcomes
Number of subjects who experience adverse events per NCI-CTCAE 5.0
Time frame: At 12 months
Number of subjects who experience adverse events per NCI-CTCAE 5.0
Time frame: At 36 months
Number of subjects who receive prostate cancer treatment
Time frame: At 12 months
Number of subjects who receive prostate cancer treatment
Time frame: At 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristina Pasat-karasik, RN contact
Sujit S Nair, PhD study director
Assistant Professor and Director of GU Immunotherapy Research
Dimple Chakravarty, PhD study director
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Poly-ICLC intramuscular (IM) injection and Poly-ICLC, Intertumoral (IT) injection in people with Prostate Cancer Patients on Active Surveillance, run by Ashutosh Kumar Tewari at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 35 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monali Fatterpekar, PhD (212-241-0751, monali.fatterpekar@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects without Gleason group upgrade after treatment (time frame: at 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.