Re-treatment with 177Lu-PSMA-617 for Treating Advanced Prostate Cancer Resistant to Hormone Therapy

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06288113

Provider View

This study is exploring the effectiveness of re-treating prostate cancer patients with the radioactive drug 177Lu-PSMA-617, who have previously responded well to this treatment. The trial focuses on patients whose cancer has spread and continues to grow despite hormone therapy.

Patient Parameters

Program Overview

This phase II study is testing how well re-treatment with the radioactive drug 177Lu-PSMA-617 works for patients with prostate cancer that has spread to other parts of the body and is resistant to hormone therapy. The cancer must have previously responded well to an initial treatment with 177Lu-PSMA-617. This drug targets a protein on prostate cancer cells, delivering radiation to kill them. The study aims to see if re-treatment can improve survival and control the disease in these patients.

Description

Primary Objective:

  • To evaluate how effective re-treating with 177Lu-PSMA-617 is for patients with advanced prostate cancer that has spread and is resistant to hormone therapy, who previously responded well to this treatment.

Secondary Objectives:

  • To assess the safety of re-treatment with 177Lu-PSMA-617.
  • To measure how many patients experience a significant drop in prostate-specific antigen (PSA) levels during re-treatment.
  • To evaluate how long patients live without the cancer getting worse, based on specific guidelines.
  • To determine overall survival from the start and end of the first treatment with 177Lu-PSMA-617.
  • To assess how long patients live without the cancer spreading further, using specific imaging criteria.
  • To evaluate the impact of re-treatment on bone pain, quality of life, and daily functioning using standardized questionnaires.

Exploratory Objective:

  • To study how the re-treatment affects radiation levels in organs and tumors using a specific dosimetry protocol.

Study Outline:

Participants will receive 177Lu-PSMA-617 through an IV on the first day of each treatment cycle. The treatment is repeated every 6 weeks for up to 6 cycles, unless the cancer progresses or side effects become unacceptable. Participants will also receive a different radioactive drug for imaging and have various scans and blood tests throughout the study.

After completing the treatment, participants will have follow-up visits within 8 weeks and then every 3 months for up to 2 years.

Eligibility Criteria

Inclusion Criteria

  • Have advanced prostate cancer that has spread and is resistant to hormone therapy.
  • Have received at least one chemotherapy treatment for this type of cancer.
  • Have taken at least one medication that blocks male hormones.
  • Have completed at least 4 cycles of 177Lu-PSMA-617 treatment before.
  • Have shown a significant drop in PSA levels during the first 177Lu-PSMA-617 treatment and not started new prostate cancer treatments within two months after completing it.
  • Have experienced an increase in PSA levels after the first treatment, confirmed by a second test at least 3 weeks apart.
  • Meet specific imaging criteria with a PSMA PET/CT scan done within 8 weeks before starting re-treatment.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Be able to understand and sign a consent form and follow all study requirements.

Exclusion Criteria

  • Started new prostate cancer treatments within two months after completing the first 177Lu-PSMA-617 treatment, except for certain hormone therapies.
  • Received certain cancer treatments that affect bone marrow or other radioactive treatments within the last 6 weeks.
  • Have kidney function below a specific level.

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