Study on Adjusting 177Lu-PSMA-617 Treatment for Advanced Prostate Cancer

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06200103

Provider View

This clinical trial is exploring whether a modified schedule of the treatment 177Lu-PSMA-617 can be as effective as the standard schedule for men with advanced prostate cancer that has spread and is resistant to hormone therapy.

Patient Parameters

Program Overview

This study is testing a new approach to using 177Lu-PSMA-617, a treatment for prostate cancer that has spread and is resistant to hormone therapy. The treatment uses a radioactive substance to target and destroy cancer cells. The trial compares two different schedules: one with a pause after 5 cycles and another with continuous treatment for 6 cycles. The goal is to see if the shorter schedule is just as effective in controlling the cancer.

Description

The main goal of this study is to see if taking a break after 5 cycles of 177Lu-PSMA-617 treatment is as effective as the standard 6 cycles in keeping the cancer from progressing. Researchers will also look at how long it takes for patients to need another treatment, how long it takes for the cancer to progress, overall survival rates, and any side effects. They will also assess changes in patients' quality of life.

Participants will be randomly assigned to one of three groups:

  • Group 1: Receive 177Lu-PSMA-617 every 42 days for 5 cycles, with the option for an additional cycle if the cancer responds well. Patients will also have scans and blood tests.
  • Group 2: Receive 177Lu-PSMA-617 every 42 days for 5 cycles, then pause treatment until the cancer progresses, at which point they will resume treatment. Patients will also have scans and blood tests.
  • Group 3: Start with observation until the cancer progresses, then receive 177Lu-PSMA-617 every 42 days for 6 cycles. Patients will also have scans and blood tests.

After completing the study treatment, patients will have follow-up visits every 12 weeks for up to 2 years or until the cancer progresses.

Eligibility Criteria

Inclusion Criteria

  • Scheduled for treatment with 177Lu-PSMA-617 at Mayo Clinic Rochester.
  • Have prostate cancer that is resistant to hormone therapy and has spread, confirmed by specific imaging tests.
  • Willing to provide blood samples for research.
  • Able to provide written consent and complete questionnaires.
  • Willing to return for follow-up visits.
  • Show a near-complete response on scans after 2-5 cycles of treatment.
  • Have adequate blood counts and organ function.
  • No severe side effects that would prevent further treatment.
  • For those pausing treatment, cancer must show signs of progression before resuming treatment.

Exclusion Criteria

  • Have another active cancer requiring treatment.
  • Taking other experimental treatments for prostate cancer.
  • Have not recovered from side effects of previous treatments, except for mild, stable neuropathy.
  • Have uncontrolled illnesses or conditions that would interfere with the study.
  • Unable to use effective birth control if able to father a child.
  • Have severe health issues that would make participation unsafe.
  • Have had a heart attack in the past 6 months or have severe heart failure.
  • Experience serious side effects during the study.

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