Study on Radium Ra 223, Hormone Therapy, and Targeted Radiation for Treating Metastatic Prostate Cancer

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT03361735

Provider View

This clinical trial is exploring a combination of treatments, including Radium Ra 223, hormone therapy, and targeted radiation, to see if they can better treat prostate cancer that has spread to other parts of the body.

Patient Parameters

Program Overview

This study is testing a combination of treatments for prostate cancer that has spread beyond the prostate. The treatments include Radium Ra 223, which is a radioactive substance that targets bones to kill cancer cells, hormone therapy to lower testosterone levels, and a precise form of radiation therapy called stereotactic body radiation therapy (SBRT). The goal is to see if this combination can more effectively treat prostate cancer.

Description

The main goal of this study is to see how long it takes for the cancer to stop responding to the treatment combination of hormone therapy, targeted radiation, and Radium Ra 223. Researchers also want to know if adding Radium Ra 223 is safe and how it affects prostate-specific antigen (PSA) levels and overall response to treatment. They will also look at how long patients live without the cancer getting worse and how long they live overall. The study will also monitor any long-term side effects over a five-year period.

Participants will start hormone therapy about four weeks before radiation treatment and continue it for up to 32 weeks. They will receive targeted radiation in 3-5 sessions over 7-21 days and Radium Ra 223 through an IV every 28 days for up to 7 cycles, as long as the cancer does not progress or cause unacceptable side effects. After completing the treatment, participants will be followed for up to five years to monitor their health and any changes in their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Must agree to provide a sample of tumor tissue if available.
  • Must have a performance status score of 0 to 2, indicating they are fully active or have some limitations but are still able to care for themselves.
  • Must have a life expectancy of more than 12 months.
  • Must have a diagnosis of prostate adenocarcinoma, with certain conditions allowing for some neuroendocrine differentiation.
  • Must have metastatic prostate cancer, confirmed by imaging tests.
  • Must have up to 4 metastatic lesions, with at least one in the bone and others meeting specific size and location criteria.
  • If the primary prostate cancer is untreated, must undergo surgery to remove part of the prostate.
  • Must not have castration-resistant prostate cancer.
  • Must have a PSA level of 0.2 or higher before starting hormone therapy.
  • Must have started hormone therapy 28 days before the first day of the study treatment.
  • Must have refused standard chemotherapy for metastatic prostate cancer.
  • Must have recovered from any side effects of previous treatments.
  • Must meet specific blood count and organ function criteria.

Exclusion Criteria

  • Cannot have had previous treatment with Radium Ra 223.
  • Cannot have had chemotherapy for metastatic or recurrent prostate cancer, except for certain allowed treatments.
  • Cannot have had radiation treatment for metastatic prostate cancer.
  • Cannot have had surgery to remove the testicles.
  • Cannot have unstable medical conditions, such as uncontrolled heart problems.
  • Cannot have brain metastases or a history of them.
  • Cannot have uncontrolled HIV infection.
  • Cannot have any condition that would make participating in the study unsafe or difficult.

Locations

FACILITYZIPCITYSTATE
City of Hope Medical Center91010DuarteCalifornia

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