OncoMatch/Clinical Trials/NCT05113537
Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer
Is NCT05113537 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Abemaciclib and Lutetium Lu 177-PSMA-617 for castration-resistant prostate carcinoma.
Treatment: Abemaciclib · Lutetium Lu 177-PSMA-617 — This phase I/II trial tests the safety, side effects, and best dose of abemaciclib and whether it works before 177Lu-PSMA-617 in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abemaciclib is in a class of medications called kinase inhibitors. It is highly selective inhibitors of cyclin-dependent kinase 4 and 6, which are proteins involved in cell differentiation and growth. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. Radioligand therapy uses a small molecule (in this case 177Lu-PSMA-617), which carries a radioactive component to destroys tumor cells. When 177Lu-PSMA-617 is injected into the body, it attaches to the prostate-specific membrane antigen (PSMA) receptor found on tumor cells. After 177Lu-PSMA-617 attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving abemaciclib before 177Lu-PSMA-617 may help 177Lu-PSMA-617 kill more tumor cells.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: AR castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L)
ongoing androgen-deprivation therapy and a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L)
Disease stage
Required: Stage IV, IVA, IVB
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: novel hormonal agent (abiraterone acetate, enzalutamide, apalutamide, darolutamide)
Prior treatment with at least one novel hormonal agents (NHA) such as abiraterone acetate, enzalutamide, apalutamide, darolutamide etc.
Must have received: orchiectomy and/or ongoing androgen-deprivation therapy
Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy
Cannot have received: CDK4/6 inhibitor
Patients with prior treatment with CDK4/6 inhibitors
Cannot have received: PSMA-targeted radioligand therapy
Exception: Patients with previous treatment with PSMA targeting therapies (Such as Chimeric antigen receptor T cells (CAR-T) or Bi-specific T-cell engagers (BiTEs)) are eligible.
Patients with prior treatment with PSMA-targeted radioligand therapy
Cannot have received: Radium-223 (Radium-223)
Patients treated with Radium-223 within 6 weeks prior to study entry
Cannot have received: systemic anti-cancer therapy
Any systemic anti-cancer therapy within 3 weeks of study entry
Lab requirements
Blood counts
WBC > 2.5; ANC > 1.5; Hgb > 8.0 (transfusion allowed, treatment must not begin earlier than the day after transfusion); Platelets > 100,000
Kidney function
Creatinine <= 1.5 x ULN OR creatinine clearance (GFR) >= 30 mL/min/1.73 m^2 (Cockcroft-Gault equation)
Liver function
Total bilirubin <= 1.5 x ULN (<= 2 ULN for Gilbert's Syndrome and direct bilirubin within normal limits permitted); AST/ALT <= 3 x ULN (<= 5 x ULN for patients with liver metastases)
adequate organ function as outlined below and bone marrow reserve
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, San Francisco · San Francisco, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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