Neoadjuvant Hiltonol® (PolyICLC) for Prostate Cancer

ID#: NCT03262103

Age: 18 years - 66+

Gender: Male

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: May 01, 2017

End Date: May 01, 2020

Contact Information:
Lily Davenport, RN
Cristina Pasat-karasik, RN
Summary: The purpose of this study is to test an approach of stimulating the body's immune system to attack prostate cancer. This study will test injection of a substance polylysine and carboxymethylcellulose (Poly-ICLC, Hiltonol®)through a needle guided by MRI (magnetic resonance imaging) ultrasound fusion technology into the prostate gland. Poly ICLC has been used to help the body in its fight against cancer. The first aim of the study is to determine the highest dose of a substance Poly-ICLC (Hiltonol®) that can be safely tolerated by the study participants. The second aim of the study is to find out the toxicity or side effects of poly-ICLC.

Inclusion Criteria:

1. Written informed consent and HIPAA authorization for release of personal health information.

2. Age > 18 years at the time of consent.

3. ECOG Performance Status of 0-1 within 14 days prior to being registered for protocol therapy (Study Procedure Manual).

4. Histologically confirmed adenocarcinoma of the prostate (with previous diagnostic tissue available for tumor marker analysis).

5. Gleason 7

- 10, cT2a

- cT3b adenocarcinoma of the prostate with plans for radical prostatectomy

6. PSA ≥ 4 ng/ml

7. Tumor visible on multiparametric MRI

8. Tolerated previous transrectal ultrasound guided biopsy procedure under local anesthetic a. Uncomplicated previous TRUS biopsy procedure (i.e., no prior hospitalization due to sepsis, prostatic abscess or severe hemorrhage following TRUS prostate biopsy)

9. Willing to undergo the intra-tumoral (IT) injection of the Poly-ICLC into the prostatic tumor as per the protocol

10. No prior hormonal therapy with the exception of oral 5-alpha-reductase inhibitors (finasteride, dutasteride, etc.). Patients who have received prior oral anti-androgen therapies (bicalutamide, flutamide, nilutamide, etc.) must be off treatment for at least 6 weeks prior to enrollment. Patients who have received prior LHRH agonist or antagonist therapy (leuprolide, goserelin acetate, etc.) are eligible provided serum testosterone is > 50 mg/dl.

11. No prior radiation therapy (external beam or brachytherapy) to the pelvis or prostate.

12. No clinically significant infections as judged by the treating investigator.

13. No characteristics suggesting a potential higher risk of infection with intraprostatic injections:

1. Recurrent urinary tract infections or history of prostatitis within 3 months prior to enrollment into the study.

2. Urine analysis positive for nitrites and leucocyte esterase. Such patients could be considered for the study after treatment and resolution of the infection.

3. Active proctitis

4. History of prostatic abscess

5. Taking immunosuppressive medication including systemic corticosteroids

6. Active hematologic malignancy

14. No uncontrolled angina, congestive heart failure or MI within 6 months.

15. Patients 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.

16. No treatment with any investigational agent for any medical condition within 28 days prior to being registered for protocol therapy.

17. Adequate end organ function as determined by the following laboratory values:

- White blood cell count (WBC) > 2.5 k/mm3

- Absolute neutrophil count (ANC) > 1.5 k/mm3

- Hemoglobin (Hgb) > 8.0 g/dL

- Platelets > 100 k/mm3

- 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

18. Able to speak, read and write in English.