Study on Abemaciclib Before 177Lu-PSMA-617 for Treating Metastatic Castration-Resistant Prostate Cancer

Sponsor: Vadim S Koshkin

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05113537

Provider View

This clinical trial is exploring the safety and effectiveness of using the drug abemaciclib before a radioligand therapy called 177Lu-PSMA-617 to treat prostate cancer that has spread and is resistant to hormone therapy. The study aims to find the best dose and see if this combination can help reduce cancer cells more effectively.

Patient Parameters

Program Overview

This study is testing a new treatment approach for prostate cancer that has spread and is resistant to hormone therapy. It involves using a drug called abemaciclib, which blocks proteins that help cancer cells grow, before giving a radioligand therapy called 177Lu-PSMA-617. This therapy uses a radioactive component to target and destroy cancer cells. The goal is to see if starting with abemaciclib can make the radioligand therapy more effective in killing cancer cells.

Description

The study is divided into two parts: Phase I and Phase II. In Phase I, researchers will determine the safest dose of abemaciclib to use before the radioligand therapy 177Lu-PSMA-617. They will also monitor for any side effects. In Phase II, the focus will be on how well this combination works in reducing cancer markers and controlling the disease.

Participants will take abemaciclib by mouth twice a day for 14 days, followed by an intravenous dose of 177Lu-PSMA-617. This cycle will repeat every 6 weeks for up to 4 cycles, as long as the cancer does not progress and side effects are manageable.

After completing the treatment, participants will have follow-up visits at 30 days and then every 3 months for up to 2 years to monitor their health and the treatment's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed prostate cancer.
  • Age 18 or older.
  • Cancer must be metastatic and resistant to hormone therapy.
  • Must have adenocarcinoma type of prostate cancer.
  • Previous treatment with at least one hormone therapy and one chemotherapy.
  • Must have had surgery or ongoing hormone therapy to lower testosterone levels.
  • Must have a specific type of PET scan showing PSMA-positive lesions.
  • Must be in good overall health with a performance status of 0-2.
  • Must have a life expectancy of more than 6 months.
  • Must have adequate organ function and blood cell counts.
  • Must be able to swallow pills.
  • Must understand and agree to the study requirements.
  • HIV-positive individuals on effective treatment are eligible.
  • Hepatitis B or C must be under control if present.
  • Must agree to use effective contraception during the study and for 2 months after.

Exclusion Criteria

  • Cannot have small cell or neuroendocrine prostate cancer.
  • Cannot have a 'super scan' on bone scan.
  • Cannot have used CDK4/6 inhibitors or PSMA-targeted radioligand therapy before.
  • Cannot have had certain radioactive treatments within 6 months.
  • Cannot have had any cancer treatment within 3 weeks of starting the study.
  • Cannot have unresolved severe side effects from previous radiation.
  • Cannot have untreated brain metastases or spinal cord issues.
  • Cannot have other serious medical conditions that could interfere with the study.
  • Cannot have active infections requiring treatment.
  • Cannot have a history of serious heart conditions.
  • Cannot be participating in another clinical trial.

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