OncoMatch/Clinical Trials/NCT04633252
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
Is NCT04633252 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for cancer of prostate.
Treatment: PDS01ADC · Docetaxel · M7824 · Prednisone · ADT — Background: Metastatic castration sensitive and castration resistant prostate cancer (mCSPC and mCRPC) are prostate cancers that have spread to other parts of the body. Use of the drug docetaxel with androgen deprivation therapy can improve survival for men with mCSPC. Researchers want to see if combining this treatment with other drugs can help delay the time it takes for mCSPC and mCRPC to get worse. Objective: To learn if giving docetaxel with PDS01ADC is safe and effective for men with prostate cancer. Eligibility: Men age 18 and older with mCSPC or mCRPC. Design: Participants will be screened with a medical history and physical exam. Their diagnosis will be confirmed. Their symptoms and how well they do their normal activities will be reviewed. They will have blood and urine tests. Their heart will be evaluated. They will have imaging scans of the chest, abdomen, and pelvis. They will have bone scans with intravenous (IV) injections of Tc99 to check for tumor spread in the bones. Some screening tests will be repeated during the study. Participants may have tumor biopsies. Participants will get treatment in cycles. Each cycle will last 21 days. They will get docetaxel through IV infusion. They will get PDS01ADC as an injection under the skin. Participants with mCSPC will have up to 6 cycles. Those with mCRPC will be treated until they cannot tolerate the side effects or their disease gets worse. Participants will have a follow-up visit 30 days after treatment ends. Those with mCSPC will then have follow-up visits at the clinic every 3 months.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: androgen deprivation therapy — mCSPC
Participants must be within 134 days of starting ADT.
Must have received: antiandrogen (abiraterone, enzalutamide, apalutamide, darolutamide) — mCRPC
Must have been previously treated with modern anti-androgens such as abiraterone, enzalutamide, apalutamide, or darolutamide.
Cannot have received: docetaxel
Exception: Allowed if given for mCSPC and no progression while on docetaxel or within 3 months of completing docetaxel for mCSPC.
Participants who have had prior docetaxel for mCRPC
Cannot have received: docetaxel
Participants who have had progression within 3 months of completing docetaxel for mCSPC
Cannot have received: abiraterone
mCSPC participants will be excluded if they did not start abiraterone within 6 weeks of ADT
Cannot have received: docetaxel
mCSPC participants will be excluded if they had any docetaxel
Lab requirements
Blood counts
Absolute neutrophil count >=1,500/mcL, without CSF support; Platelets >=100,000/mcL; Hemoglobin >9 g/dL; PT <= 1.5 x ULN; aPTT <= 1.5 x ULN; Serum albumin >=2.8 g/dL
Kidney function
Serum Creatinine OR Creatinine Clearance <= 1.5 X ULN OR >=50 mL/min/1.73 m^2 calculated by eGFR in the clinical lab for participants with serum creatinine levels > 1.5 ULN
Liver function
Total bilirubin <= ULN (or <= 3.0 in Gilbert's syndrome); AST(SGOT)/ALT(SGPT) <=1.5 X ULN; Hepatic function based on Child-Pugh Class: Participants with hepatic impairment must have Child-Pugh Class A or better
Participants must have adequate organ and marrow function as defined below: Absolute neutrophil count >=1,500/mcL, without CSF support; Platelets >=100,000/mcL; Hemoglobin >9 g/dL; PT <= 1.5 x ULN; aPTT <= 1.5 x ULN; Total bilirubin <= ULN (or <= 3.0 in Gilbert's syndrome); Serum albumin >=2.8 g/dL; AST(SGOT)/ALT(SGPT) <=1.5 X ULN; Hepatic function based on Child-Pugh Class: Participants with hepatic impairment must have Child-Pugh Class A or better; Serum Creatinine OR Creatinine Clearance <= 1.5 X ULN OR >=50 mL/min/1.73 m^2 calculated by eGFR in the clinical lab for participants with serum creatinine levels > 1.5 ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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