OncoMatch/Clinical Trials/NCT04989946
Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer
Is NCT04989946 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments for prostate cancer.
Treatment: Degarelix · pTVG-AR · Nivolumab · Cemiplimab · Fianlimab · FLT PET/CT — The current protocol will examine the use of a plasmid DNA vaccine encoding AR, alone or with T-cell checkpoint blockade, to induce and/or augment therapeutic T-cells following androgen deprivation in patients with newly diagnosed prostate cancer scheduled to undergo prostatectomy. Patients without evidence of metastatic disease, with tissue remaining from a pre-treatment biopsy, and who are being considered for standard treatment by prostatectomy, will be invited to participate and will be on study for up to 15 months.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Endocrine / hormonal
Other
Cancer type
Prostate Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: androgen deprivation therapy
Prior treatment for prostate cancer, including androgen deprivation therapy (ADT), orchiectomy, antiandrogens, ketoconazole, abiraterone acetate or enzalutamide
Cannot have received: radiation therapy
Prior radiation to the prostate
Lab requirements
Blood counts
ANC > 1000 / mm3; HgB > 9.0 gm/dL independent of transfusion; Platelets > 100,000 / mm3
Kidney function
Creatinine < 2.0 mg/dL
Liver function
AST, ALT < 2.5 x institutional ULN; total bilirubin < 2x institutional ULN (Gilbert's syndrome exception: if direct bilirubin is within normal range, subject may be eligible)
Adequate hematologic, renal and liver function as evidenced by the following within 4 weeks of day 1: Absolute neutrophil count (ANC) > 1000 / mm3; HgB > 9.0 gm/dL independent of transfusion; Platelets > 100,000 / mm3; Creatinine < 2.0 mg/dL; AST, ALT < 2.5 x institutional ULN; Total bilirubin < 2x institutional ULN (NOTE: in subjects with Gilbert's syndrome, if total bilirubin is >2x ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Wisconsin Carbone Cancer Center · Madison, Wisconsin
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04989946 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages