Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05113537

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

Led by Vadim S Koshkin · Updated on 2026-04-13

30

Participants Needed

1

Research Sites

286 weeks

Total Duration

On this page

Sponsors

V

Vadim S Koshkin

Lead Sponsor

P

Prostate Cancer Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed prostate cancer
  • Age 18 years or older
  • Metastatic castration-resistant prostate cancer with progression based on PCWG3 criteria
  • Adenocarcinoma histology
  • Prior treatment with at least one novel hormonal agent (e.g., abiraterone acetate, enzalutamide, apalutamide, darolutamide)
  • Prior orchiectomy and/or ongoing androgen-deprivation therapy with castrate serum testosterone level (< 50 ng/dL or < 1.7 nmol/L)
  • At least one PSMA-positive lesion on 68Ga-PSMA-11 PET scan before starting abemaciclib
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Life expectancy greater than 6 months
  • Adequate organ function and bone marrow reserve as specified
  • Ability to swallow oral medications
  • Ability to understand and sign informed consent
  • HIV-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months
  • Undetectable HBV viral load on suppressive therapy if indicated
  • Treated and cured or undetectable viral load for HCV infection
  • Prior or concurrent malignancies that do not interfere with safety or efficacy assessments
  • Agreement to use effective contraception and not donate sperm during the study and for 2 months after last dose
Not Eligible

You will not qualify if you...

  • Small cell or neuroendocrine carcinoma histology
  • Super scan on baseline bone scan
  • Prior treatment with CDK4/6 inhibitors
  • Prior treatment with PSMA-targeted radioligand therapy (except CAR-T or BiTE therapies)
  • Radium-223 treatment within 6 weeks prior to study entry
  • Any systemic anti-cancer therapy within 3 weeks prior to study entry
  • Significant radiation-related adverse events (grade 3 or higher) or unresolved radiation-related adverse events
  • History of central nervous system metastases unless asymptomatic and treated
  • Symptoms of cord compression or impending cord compression
  • Serious concurrent medical conditions as determined by investigator
  • Other significant malignancies expected to affect life expectancy or disease assessment
  • Not recovered from prior anti-cancer therapy adverse events beyond grade 1 (except alopecia or peripheral neuropathy)
  • Serious or uncontrolled preexisting medical conditions that preclude participation
  • Active systemic bacterial, fungal, or detectable viral infections
  • Personal history of syncope of cardiovascular origin, pathological ventricular arrhythmias, or sudden cardiac arrest
  • Currently receiving other investigational therapeutic agents

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

U

UCSF Genitourinary Medical Oncology Recruitment

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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