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New treatment option for Prostate Cancer Patients on Active Surveillance
Official title Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance
ClinicalTrials.gov ID: NCT06343077
What this study is testing
What is Poly-ICLC intramuscular (IM) injection?
Poly-ICLC intramuscular (IM) injection is an investigational medicine, given as an once-weekly injection into a muscle, being studied as a potential treatment for prostate cancer patients on active surveillance.
Also referred to as Hiltonol®, Polyinosinic-Polycytidylic acid stabilized with polylysine and carboxymethylcellulose.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the...
- 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)
You likely can't join if
- Received local or systemic curative therapy for prostate cancer
- people 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.
See the full eligibility criteria
- 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)
- 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.). people 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 people 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.
- people 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...
- 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...
- 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
- Received local or systemic curative therapy for prostate cancer
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.