OncoMatch/Clinical Trials/NCT05751941
Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer
Is NCT05751941 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Abiraterone and Enzalutamide for prostate cancer.
Treatment: Abiraterone · Enzalutamide · Apalutamide · Sipuleucel-T — This study is designed to test the hypothesis that using Sipuleucel-T (Provenge) in combination with new hormonal agents (NHA) (abiraterone, enzalutamide, apalutamide) for the treatment of participants with asymptomatic metastatic castration resistant prostate cancer (mCRPC) and no visceral metastases would enhance the activation of antigen presenting cells (APC) by sipuleucel-T.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: androgen deprivation therapy (LHRH analog) — metastatic
On combined ADT with LHRH analog and a NHA (enzalutamide, apalutamide or abiraterone) for metastatic prostate cancer with PSA progression, but no imaging progression
Must have received: new hormonal agent (enzalutamide, apalutamide, abiraterone) — metastatic
On combined ADT with LHRH analog and a NHA (enzalutamide, apalutamide or abiraterone) for metastatic prostate cancer with PSA progression, but no imaging progression
Cannot have received: chemotherapy
Exception: within 4 weeks prior to entering the study
Participants who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
Cannot have received: radiation therapy
Exception: within 4 weeks prior to entering the study
Participants who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
Cannot have received: sipuleucel-T (sipuleucel-T)
Prior treatment with sipuleucel-T
Cannot have received: investigational compound
Exception: within 30 days prior to the first dose of Sipuleucel-T
Treatment with any investigational compound within 30 days prior to the first dose of Sipuleucel-T
Lab requirements
Blood counts
Absolute neutrophil count ≥1,000/mcL; Platelets ≥100,000/mcL; Hemoglobin > 10 g/dl
Kidney function
Creatinine 1.5 ≤ institutional ULN
Liver function
AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
Cardiac function
No uncontrolled arrhythmia; patients with h/o myocardial infarction or history of congestive heart failure, need to have estimated left ventricle ejection fraction above 40% either on echocardiogram or MUGA scan within 6 months of study enrollment
Participants must have adequate organ and marrow function as defined below: Absolute neutrophil count ≥1,000/mcL; Platelets ≥100,000/mcL; Hemoglobin > 10 g/dl; AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN; Creatinine 1.5 ≤ institutional ULN; No uncontrolled arrhythmia: patients with h/o myocardial infarction or history of congestive heart failure, need to have estimated left ventricle ejection fraction above 40% either on echocardiogram or MUGA scan within 6 months of study enrollment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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