Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer
Completed · Phase 2
Conditions studied: Adenocarcinoma of the Prostate
In brief
Open-label, dose rising, Phase IIa trial of intratumorally-injected NanoPac® 6, 10, or 15 mg/mL in subjects with prostate cancer scheduled for prostatectomy.
Key facts
- Study ID
- NCT03077659
- Run by
- NanOlogy, LLC
- People needed
- 16
- Starts
- 2017-09-06
- Expected to finish
- 2018-10-04
- Last updated by the study team
- 2019-08-20
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Southern California — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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