Clareo Health | A Phase I Study of PCUR-101 in Combination With Androgen Suppression Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase I Study of PCUR-101 in Combination With Androgen Suppression Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pellficure Pharmaceuticals, Inc
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
histologically confirmed diagnosis of metastatic CRPC
standard of care androgen deprivation treatment
castrate serum level of testosterone of ≤ 50 ng/dL (≤ 1.73 mmol/L)
progressive disease while receiving androgen deprivation therapy
previously treated with abiraterone, enzalutamide alone or in combination AND must have demonstrated evidence of objective progression as per PCWG3 criteria
adequate hematologic, renal and hepatic function
KPS of ≥ 70 or ECOG of 0 to 1
You may not be if
pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer histology
use of opiate analgesics for prostate cancer pain within 4 week of treatment start
more than one sequential second generation AR-directed therapy
received cytotoxic chemotherapy for either metastatic HSPC or CRPC within the last 12 weeks or other investigational agents within 4 weeks
history of bleeding disorder
history of seizure disorder
concomitant use of therapeutic anticoagulation
history of or current cardiac issues
received external beam radiation therapy within 4 weeks