OncoMatch/Clinical Trials/NCT06085664
A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy
Is NCT06085664 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including REGN5678 and Piflufolastat F18 for prostate cancer.
Treatment: REGN5678 · Piflufolastat F18 — To learn about the safety and effects of a drug called REGN5678 when it is given to patients with high-risk prostate cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Grade: gleason 8 or greater (gleason)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: surgery
Exception: excluding transurethral resection of the prostate [TURP]
No prior treatment for prostate cancer including prior surgery (excluding transurethral resection of the prostate [TURP])
Cannot have received: cryoablation
No prior treatment for prostate cancer including ... cryoablation
Cannot have received: pelvic lymph node dissection
No prior treatment for prostate cancer including ... pelvic lymph node dissection
Cannot have received: radiation therapy
No prior treatment for prostate cancer including ... radiation therapy
Cannot have received: hormonal therapy
Exception: 5-alpha reductase inhibitors allowed
No prior treatment for prostate cancer including ... hormonal therapy
Cannot have received: chemotherapy
No prior treatment for prostate cancer including ... chemotherapy
Cannot have received: orchiectomy
Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists/antagonists
Cannot have received: antiandrogen
Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists/antagonists
Cannot have received: ketoconazole
Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists/antagonists
Cannot have received: estrogen
Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists/antagonists
Cannot have received: LHRH agonist
Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists/antagonists
Cannot have received: LHRH antagonist
Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists/antagonists
Lab requirements
Blood counts
hemoglobin ≥ 11 g/dl, absolute neutrophil count ≥ 1.5 x 10^9/l, platelet count ≥ 100 x 10^9/l
Kidney function
serum creatinine ≤ 1.5 x uln or estimated glomerular filtration rate > 50 ml/min/1.73 m^2
Liver function
total bilirubin ≤ 1.5 x uln (gilbert's syndrome exception), ast ≤ 2.5 x uln, alt ≤ 2.5 x uln, alp ≤ 2.5 x uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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