Study on Using ctDNA Levels to Guide Early Stopping of 177Lu-PSMA-617 Treatment in Metastatic Castration-Resistant Prostate Cancer

Sponsor: University of Washington

Sponsor score: 40

ClinicalTrials ID:NCT07698535

Provider View

This clinical trial is exploring whether measuring a specific type of DNA in the blood, called circulating tumor DNA (ctDNA), can help decide when to stop a treatment called 177Lu-PSMA-617 early in patients with prostate cancer that has spread and is resistant to hormone therapy.

Patient Parameters

Program Overview

The study aims to find out if checking the levels of circulating tumor DNA (ctDNA) in the blood can help doctors decide when to stop the treatment 177Lu-PSMA-617 early in patients with prostate cancer that has spread and is resistant to hormone therapy. ctDNA is a type of DNA released by cancer cells into the bloodstream, and measuring it might help predict how well a patient will respond to treatment. This could allow doctors to change treatments sooner if needed, potentially improving patient outcomes.

Description

In this study, patients will receive the treatment 177Lu-PSMA-617 through an IV for about 20-30 minutes on the first day of each cycle. These cycles repeat every 6 weeks for up to 2 cycles unless the cancer worsens or side effects become too severe. Blood samples will be taken to measure ctDNA levels at the start and during the second cycle. If ctDNA levels are low, patients will continue with the same treatment. If ctDNA levels are higher, patients will be randomly assigned to one of two groups: one group will continue with 177Lu-PSMA-617, and the other will switch to a different treatment called docetaxel, given every 3 weeks. All patients will have scans and additional blood tests throughout the study. After finishing the study treatment, patients will have follow-up visits every 12 weeks for up to a year.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older.
  • Diagnosed with prostate cancer that has spread and is resistant to hormone therapy.
  • Evidence of cancer spread on scans.
  • Previous treatment with at least one hormone therapy drug.
  • Eligible for treatment with either 177Lu-PSMA-617 or docetaxel.
  • Good overall health with specific blood counts and organ function within normal ranges.
  • Able to provide blood samples and follow study procedures.

Exclusion Criteria

  • Serious medical or psychiatric conditions that could affect safety or consent.
  • Prostate cancer with neuroendocrine or small cell features.
  • Recent cancer treatment or radiation therapy within 2 weeks before starting the study.
  • Uncontrolled medical conditions or infections.
  • HIV positive with low CD4 count.
  • Active hepatitis B or C infection.
  • Recent major surgery or serious heart conditions.
  • Previous treatment with certain chemotherapy drugs.
  • Brain metastases or active spinal disease.

Locations

FACILITYZIPCITYSTATE
Fred Hutch/University of Washington Cancer Consortium98109SeattleWashington

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