Study Comparing 177Lu-PSMA-617 with Standard Treatment for Advanced Prostate Cancer

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04720157

Provider View

This clinical trial is testing a new treatment, 177Lu-PSMA-617, combined with standard care, against standard care alone in men with advanced prostate cancer. The study aims to see if the new combination is more effective and safe.

Patient Parameters

Program Overview

The study is designed to evaluate if adding 177Lu-PSMA-617 to the standard treatment for advanced prostate cancer can improve outcomes. Standard treatment includes therapies that target androgen receptors and reduce androgen levels. The trial involves about 1126 men from 20 countries, and as of January 2024, 1144 participants have joined. The study will last around 50 months, and participants will be randomly assigned to receive either the standard treatment alone or with 177Lu-PSMA-617.

Description

This international study involves men with advanced prostate cancer that has spread and is positive for PSMA, a specific marker seen in scans. Participants will be randomly assigned to receive either the standard treatment alone or with an additional drug, 177Lu-PSMA-617. The main goal is to see if the new combination can delay the progression of the cancer compared to the standard treatment alone.

Participants will undergo a series of scans and tests to confirm eligibility. The treatment phase involves receiving the assigned therapy, with 177Lu-PSMA-617 given every six weeks for up to six cycles if included. After treatment, participants will be monitored for safety and effectiveness, with follow-up visits to track their health and cancer status.

If the cancer progresses while on standard treatment alone, participants may switch to receive 177Lu-PSMA-617. The study will also include long-term follow-up to assess overall survival and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older.
  • Diagnosed with advanced prostate cancer that has spread and confirmed by biopsy.
  • Cancer must show PSMA positivity on specific scans.
  • Must have at least one metastatic lesion in bone, lymph nodes, or other organs.
  • Good overall health with a life expectancy of more than 9 months.
  • Adequate organ function based on blood tests.
  • HIV-positive patients can participate if they are healthy and at low risk for AIDS-related outcomes.
  • Must not have received extensive prior treatment for prostate cancer, except for limited hormone therapy.
  • Must agree to use contraception during the study and for a period after treatment.

Exclusion Criteria

  • Rapidly progressing cancer needing urgent chemotherapy.
  • Previous extensive treatment for prostate cancer, including certain chemotherapies or radioligand therapies.
  • Participation in another clinical trial or use of investigational drugs recently.
  • Known allergies to study drugs or similar medications.
  • Unstable brain metastases or other serious medical conditions that could interfere with the study.
  • Significant heart problems or other severe health issues.
  • Other active cancers that could affect life expectancy or study results.
  • Men unwilling to use condoms during and after treatment to prevent pregnancy.

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