Study on PRL-02 Injection for Advanced Prostate Cancer

Sponsor: Astellas Pharma Global Development, Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04729114

Provider View

This clinical trial is testing a new treatment called PRL-02, given as an injection, for men with advanced prostate cancer. The study aims to find the best dose and see how well it works when combined with other medications.

Patient Parameters

Program Overview

This study is exploring a new treatment for advanced prostate cancer using an injection called PRL-02. The trial is divided into two parts. In the first part, different doses of PRL-02 will be tested to find the safest and most effective amount. In the second part, the chosen dose will be given to more patients to see how well it works. Participants will receive PRL-02 injections every 84 days, along with other medications like dexamethasone and possibly docetaxel. Regular blood tests will be done to monitor prostate cancer markers and hormone levels.

Description

This clinical trial is investigating a new treatment for advanced prostate cancer using an injection called PRL-02. The study is divided into two phases. In Phase 1, different doses of PRL-02 will be tested to find the safest and most effective amount. Participants will receive PRL-02 injections every 84 days, along with a daily oral steroid. In Phase 2a, the chosen dose from Phase 1 will be given to more patients to see how well it works. Participants in this phase will receive PRL-02 with dexamethasone and possibly docetaxel, depending on their group. Throughout the study, participants will have regular blood tests to check prostate cancer markers and hormone levels.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of prostate cancer, including types that are sensitive to hormone therapy or have spread and become resistant.
  • Have had surgery to remove the testicles or are on hormone therapy for at least 6 weeks before starting the study and must continue this therapy during the study.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • For certain groups, must have previously received specific prostate cancer treatments and shown signs of disease progression.

Exclusion Criteria

  • Have active cancer spread to the brain, unless treated and stable.
  • Have another active cancer requiring treatment, except for certain skin cancers or early-stage cancers in remission.
  • Have significant heart disease.
  • Have received chemotherapy recently.
  • Are currently taking certain prostate cancer medications and have not stopped them for the required time before starting the study.
  • Have used estrogen treatments recently.
  • Need high doses of steroids, except for certain types like topical or inhaled.
  • Are taking medications that strongly affect liver enzymes.
  • Have allergies to study medications or their components.
  • Have poorly controlled diabetes with high HbA1c levels.
  • Have a body mass index over 40.

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