OncoMatch/Clinical Trials/NCT05113537
Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer
Is NCT05113537 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Radioligand therapy
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 →Frequently asked questions
Is NCT05113537 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CDK4/6 inhibitor, PSMA-targeted radioligand therapy, Radium-223 disqualifies patients from enrollment.
Does this trial require AR?
Yes, AR castrate level of serum testosterone is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV or IVA or IVB is required (metastatic disease required).
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