Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT03077659
Eligibility Criteria:
Inclusion Criteria:
* Male; 18 years of age and older
* Histopathologically proven adenocarcinoma, Gleason grade ≥ 7 of the prostate planned radical prostatectomy; appropriate for treatment with paclitaxel therapy
* ECOG of 0 or 1
* 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
* Creatinine \<2 mg/dL
* Normal PT/INR and PTT;
* Willing to use appropriate contraception from time of NanoPac® injection until prostatectomy
* Willing to receive an mpMRI
Exclusion Criteria:
* Evidence of locally advanced or metastatic disease;
* Prostate size ≥ 50 cc
* Prior prostatectomy
* 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) prior to surgery
* Treatment with a prior investigational agent within 30 days of first dose of investigational medication
* Any previous local treatment of the prostate (i.e. radiation)
* Any other condition (e.g. psychiatric disorder) that, in the opinion of the Investigator, may interfere with the patient's ability to comply with the study requirements or visit schedule
* Known sensitivity to any of the study medication components
* History of prior malignancy that has not been in remission for \>5 years, with the exception of basal cell or squamous cell carcinoma.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03077659
Study Brief:
Protocol Section:
NCT03077659