Clinical trial NCT04221828: Trial of NanoPac Focal Therapy for Prostate Cancer
Official title: Phase 2 Trial of NanoPac Focal Therapy for Prostate Cancer in Subjects Undergoing Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Prostate Cancer Adenocarcinoma
Prostatic Neoplasm
Urogenital Neoplasms
Genital Neoplasms, Male
Localized Cancer
Keywords: paclitaxel
Lead sponsor: NanOlogy, LLC
Sponsor class: INDUSTRY
Collaborators: name: US Biotest, Inc.
First posted: 2020-01-09
Enrollment: 1
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, single group, safety, efficacy, and pharmacokinetic study.
Primary purpose: TREATMENT

Brief summary: This study evaluates the use of NanoPac injected directly into the prostate lesion in men with prostate cancer.

Detailed description: NanoPac is very small (submicron) particles of the chemotherapy drug, paclitaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, this submicron particle paclitaxel will be injected directly into the prostate lesion in men with prostate cancer scheduled for prostatectomy on up to three different occasions. All subjects in the study will receive NanoPac and will be evaluated to see if NanoPac is safe, well-tolerated, and has an impact on prostate cancer.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age;
* Histopathologically proven adenocarcinoma of the prostate:

  * Localized cancer;
  * Subjects with tumors classified as \<T3 per TNM classification, Gleason score≥ 6;
* Prostate tumor must be able to be visualized on mpMRI;
* Already considered to be candidate for radical prostatectomy;
* Considered appropriate for treatment with paclitaxel therapy;
* Laboratory requirements:

  * WBC \>2500/mm3
  * Neutrophil \>1500/mm3
  * Hemoglobin \>10 mg/dL
  * Platelet \>100,000/ mm3
  * AST and ALT \<2.5 x ULN
  * Total bilirubin \<1.5 x ULN
  * Calculated creatinine clearance ≥ 30 ml/min
  * Normal PT/INR and PTT;
* ECOG of 0 or 1;
* International Prostate Symptom Score (I-PSS) less than or equal to 20;
* If sexually active, willing to use double condoms from time of NanoPac injection until prostatectomy;
* Agree to all study procedures and provide signed informed consent;

Exclusion Criteria:

* Evidence of locally advanced or metastatic disease;
* Prostate size ≥ 50 cc;
* Prior prostatectomy, including surgery for any benign condition (such as TURP);
* Anticipated use of concomitant chemotherapy (other than the protocol specified agents), immunotherapy, or systemic use of hormonal therapy (such as GnRH analogs, antiandrogens, androgen receptor inhibitors, and 5-α reductase inhibitors) while on study prior to surgery;
* Treatment with a prior investigational medication within 30 days of first dose of study agent;
* Any previous local treatment of the prostate (e.g. radiation, HIFU, cryotherapy, Focal Irreversible Electroporation, Photodynamic Therapy, Laser Induced Thermometry);
* Any other condition (e.g., psychiatric disorder) that, in the opinion of the Investigator, may interfere with the subject's ability to comply with the study requirements or visit schedule;
* Known sensitivity to any of the study agent components;
* History of prior malignancy that has not been in remission for \>5 years, with the exception of basal cell or squamous cell carcinoma.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: Day 1 to Day 85
Secondary outcomes:
measure: Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score)
timeFrame: Up to 2 weeks prior to Day 1 and Day 92
measure: Tumor Response Based on Change in Percentage of Sample Considered Adenocarcinoma
timeFrame: Up to 2 weeks prior to Day 1 and Day 92
measure: Tumor Invasion Into Surrounding Tissues
timeFrame: Up to 1 month prior to Consent and Day 85
measure: Tumor Response Based on Change in Image Volume on mpMRI
timeFrame: Up to 1 month prior to Consent and Day 85
measure: Change in PSA Density
timeFrame: Up to 2 weeks prior to Day 1 and Day 85
measure: Change in PI-RADS Score
timeFrame: Up to 2 weeks prior to Day 1 and Day 85
measure: Effect on Tumor Presence in Lymph Nodes
timeFrame: Up to 2 weeks prior to Day 1 and Day 92
measure: Concentration of Paclitaxel in the Systemic Circulation Post-injection
timeFrame: Days 1, 8, 15, 29, 36, 43, 50, 57, 64, 71, and 85
measure: Presence or Absence of Paclitaxel in Ejaculate
timeFrame: Days 15, 43, 57, and 85
measure: Presence or Absence of Paclitaxel in Tissues Obtained at Prostatectomy
timeFrame: Day 92
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: US Biotest, Inc.
name: Shelagh Verco, PhD
role: STUDY_DIRECTOR
References: