OncoMatch/Clinical Trials/NCT06096870
Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy
Is NCT06096870 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Enzalutamide and PDS01ADC for prostate cancer.
Treatment: Enzalutamide · PDS01ADC — Background: Prostate cancer may return after treatment in 30,000 to 50,000 people each year. There is no clear best way to treat these people. Better treatments are needed. Objective: To test a study drug (enzalutamide), both alone and combined with a second drug (PDS01ADC), in people with prostate cancer that returned after treatment. Eligibility: People aged 18 years and older with prostate cancer that returned after treatment. Design: Participants will be screened. They will have a physical exam, with blood tests. All their urine will be collected for 24 hours. They will have imaging scans of their chest, abdomen, pelvis, and bones. Their ability to perform everyday activities will be assessed. They may opt to give a stool sample. Participants will be treated in 4-week cycles. Enzalutamide is a pill taken by mouth once a day, every day. All participants will be given a supply of this drug to take at home. PDS01ADC is injected under the skin once a month, on the first day of each cycle. Half of the participants will receive both drugs. All participants will visit the clinic once a month. Each visit should last no more than 8 hours. Blood and urine tests will be repeated. All participants will receive the study treatment for 3 cycles. Some participants may need 3 more cycles of treatment with enzalutamide only. This re-treatment can be done only once. Participants will have a follow-up visit 1 month after they finish treatment. After that, they will have visits every 6 weeks for up to 5 years. Imaging scans and blood tests will be repeated. ...
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 overexpression (PSMA+ disease on PET/CT)
Evidence of prostate cancer on PSMA PET/CT scan
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: primary treatment for prostate cancer (surgery or radiation)
History of primary treatment for prostate cancer (either surgery or radiation)
Lab requirements
Blood counts
ANC >=1,500/microliter, without G-CSF support; Platelets >=100,000/microliter; Hgb >= 10 g/dL (pRBC transfusions not allowed to achieve acceptable Hgb)
Kidney function
Creatinine < 1.5 X institution ULN OR CrCl > 45 mL/min/1.73 m^2 for participant with creatinine levels > 1.5 x institutional ULN
Liver function
AST/ALT <=2.5 x institutional ULN; Total bilirubin <= 1.5 x ULN, OR <= 3.0 ULN in participants with Gilbert's syndrome; Serum albumin >= 2.8 g/dL
Participants must have adequate organ and marrow function as defined below: * Absolute neutrophil count (ANC) >=1,500/microliter, without granulocyte colony-stimulating factor (G-CSF) support * Platelets >=100,000/microliter * Aspartate aminotransferase (AST) /Alanine aminotransferase (ALT) <=2.5 x institutional upper limit of normal (ULN) * Hemoglobin (Hgb) >= 10 g/dL (packed red blood cell (pRBC) transfusions are not allowed to achieve acceptable Hgb) * Total bilirubin <= 1.5 x ULN, OR <= 3.0 ULN in participants with Gilbert s syndrome * Serum albumin >= 2.8 g/dL * Creatinine < 1.5 X institution ULN OR --Measured or calculated creatinine clearance (CrCl) (estimated glomerular filtration rate (eGFR) may also be used in place of CrCl) > 45 mL/min/1.73 m^2 for participant with creatinine levels > 1.5 x institutional 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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