Actively Recruiting
Study of PDS01ADC with Docetaxel and Abiraterone in Men with Metastatic Castration Sensitive Prostate Cancer and PDS01ADC with Docetaxel in Castration Resistant Prostate Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-08-07
86
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying metastatic castration sensitive and castration resistant prostate cancer, which are forms of prostate cancer that have spread to other parts of the body. The trial aims to evaluate the safety and effectiveness of combining the drug docetaxel with a new immunocytokine called PDS01ADC, with or without abiraterone, in men with these types of prostate cancer. This phase III study is designed to see if adding PDS01ADC can delay disease progression and improve outcomes compared to standard treatments. Participants will receive docetaxel intravenously every 21 days in treatment cycles. Men with metastatic castration sensitive prostate cancer mCSPC will receive up to six cycles of docetaxel along with PDS01ADC injections under the skin and daily oral abiraterone plus prednisone. Men with metastatic castration resistant prostate cancer mCRPC will receive docetaxel and PDS01ADC until disease progression or unacceptable side effects occur, along with prednisone as part of their standard care. The study includes a dose escalation phase to find the safe dose of PDS01ADC, followed by expansion cohorts to assess efficacy. During the study, participants will undergo medical history review, physical exams, blood and urine tests, heart evaluations, imaging scans including bone scans, and possibly tumor biopsies. Screening tests may be repeated during treatment. Participants will be monitored for safety and treatment response through PSA blood levels, imaging, and progression-free survival. Follow-up visits occur 30 days after treatment ends and then every three months for men with mCSPC. The study may last up to about four years to enroll up to 80 participants.
CONDITIONS
Brief Title
A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer
Research Team
A
Amy R Hankin, P.A.-C
M
Melissa L Abel, M.D.
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