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 (Jun 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
Treatments studied
Other
Cancer type
Prostate Cancer
Disease stage
Grade: gleason 8 or greater (gleason)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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 →Frequently asked questions
Is NCT06085664 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