RecruitingPhase 1Phase 2NCT05113537

Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer

Phase I/II Study of CDK4/6 Inhibition With Abemaciclib to Upregulate PSMA Expression Prior to 177Lu-PSMA-617 Treatment in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC) Previously Treated With Novel Hormonal Agents and Chemotherapy


Sponsor

Vadim S Koshkin

Enrollment

30 participants

Start Date

Jul 8, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a drug called abemaciclib (which slows cancer cell growth) can help prepare the body to respond better to a radioactive treatment called lutetium-177 PSMA-617 (Lu-PSMA) in men with advanced prostate cancer that has stopped responding to hormone therapy. The theory is that abemaciclib may make prostate cancer cells express more of a target (PSMA) that the radioactive drug attaches to. **You may be eligible if...** - You are 18 or older with confirmed metastatic castration-resistant prostate cancer (prostate cancer that kept growing despite hormone therapy) - Your cancer shows the PSMA target on a specialized PET scan - You have already tried at least one newer hormone therapy (like enzalutamide or abiraterone) - Your testosterone is at castrate levels (very low) - You are in good general health (ECOG 0–2) with at least 6 months life expectancy - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have certain types of prostate cancer other than adenocarcinoma - You have significant problems with your salivary glands - You have had prior treatment with Lu-PSMA or abemaciclib - You have active or uncontrolled infection, uncontrolled diabetes, or other serious medical conditions - You have significant kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAbemaciclib

Given Orally

DRUGLutetium Lu 177-PSMA-617

Given IV


Locations(1)

University of California, San Francisco

San Francisco, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05113537


Related Trials