Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Vadim S Koshkin, MD
Headshot of Vadim S Koshkin
Vadim S Koshkin

Description

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.

Official Title

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

Details

Keywords

Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8, Metastatic Castration-resistant Prostate Carcinoma, Metastatic Castration-resistant Prostate Cancer, Carcinoma, Prostatic Neoplasms, 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid, Abemaciclib, Lutetium Lu 177-PSMA-617, Abemaciclib, 177Lu-PSMA-617

Eligibility

Location

  • UCSF accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Vadim S Koshkin, MD
    I am a genitourinary medical oncologist and in this capacity I specialize in caring for patients with bladder, prostate, kidney and testicular cancers.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vadim S Koshkin
ID
NCT05113537
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated