OncoMatch/Clinical Trials/NCT05113537
Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer
Is NCT05113537 recruiting? Yes, currently enrolling (Sep 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: PSMA (FOLH1) expression (suvmax greater than suvmax of liver)
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)
Must have received: orchiectomy and/or ongoing androgen-deprivation therapy
Cannot have received: cdk4/6 inhibitor
Cannot have received: psma-targeted radioligand therapy
Lab requirements
Blood counts
wbc > 2.5; anc > 1.5; hgb >= 8.0; platelets >= 100 x 10^9/l
Kidney function
creatinine <= 1.5 x uln or creatinine clearance (gfr) >= 30 ml/min/1.73 m
Liver function
total bilirubin <= 1.5 x uln (<= 2 uln for gilbert's syndrome); ast/alt <= 3 x uln (<= 5 x uln for patients with liver metastases)
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 disqualifies patients from enrollment.
Does this trial require FOLH1?
Yes, FOLH1 expression 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 qualify