Study on Radiation Medication Alone or Combined with Other Treatments for Advanced Prostate Cancer Not Responding to Hormonal Therapy

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04071236

Provider View

This clinical trial is exploring different treatment combinations for advanced prostate cancer that has spread and is not responding to hormonal therapy. The study compares the effects of a radiation medication alone, with an additional drug that may enhance radiation effects, and with both the enhancing drug and an immunotherapy drug.

Patient Parameters

Program Overview

This study aims to find the best treatment combination for advanced prostate cancer that has spread and is not responding to hormonal therapy. It tests a radiation medication called radium-223 dichloride alone, with a drug called M3814 that may enhance radiation effects, and with both M3814 and an immunotherapy drug called avelumab. The goal is to see which combination works best to stop the cancer from growing or spreading in the bones.

Description

The study is divided into two phases. In Phase I, researchers will determine the safest dose of M3814 when used with radium-223 dichloride, with or without avelumab, by monitoring side effects. In Phase II, they will evaluate how well these treatments work in stopping cancer progression.

Participants are randomly assigned to one of three groups:

  • Group A: Receives radium-223 dichloride through an IV every 28 days for up to 6 cycles, unless the cancer progresses or side effects become unacceptable. Regular blood tests, bone scans, and imaging tests are conducted.

  • Group B: Receives radium-223 dichloride as in Group A, plus M3814 taken orally once or twice daily on specific days. Treatment repeats every 28 days for up to 6 cycles, with regular monitoring.

  • Group C: Receives radium-223 dichloride and M3814 as in Group B, plus avelumab through an IV on specific days of cycles 2-6. Treatment repeats every 28 days for up to 6 cycles, with regular monitoring.

After completing the study treatment, participants are followed up at 30 days and then every 3 months for up to 2 years to monitor their health and any changes in their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have advanced prostate cancer that has spread to bones and is not responding to hormonal therapy.
  • Must be on antiandrogen therapy unless surgically castrated.
  • Have at least two bone metastases and possibly small lymph node metastases.
  • Have a rising PSA level of 1 ng/mL or higher.
  • Have tried at least one previous treatment like abiraterone or chemotherapy.
  • Have a life expectancy of at least 6 months.
  • Meet specific blood and organ function criteria.
  • HIV-positive patients must have an undetectable viral load.
  • Hepatitis B and C patients must have controlled or cured infections.
  • Must be able to swallow pills and provide informed consent.
  • Men must agree to use contraception during and after the study.

Exclusion Criteria

  • Have active autoimmune conditions or are on chronic immunosuppression.
  • Have had recent chemotherapy or radiotherapy.
  • Have not recovered from previous cancer treatment side effects.
  • Have had prior radionuclide therapy.
  • Are taking other investigational drugs.
  • Have untreated spinal cord compression or bone fractures.
  • Have allergies to study drugs.
  • Cannot stop certain medications that interact with study drugs.
  • Have uncontrolled illnesses or psychiatric conditions.
  • Have active infections requiring treatment.
  • Are on immunosuppressive medication within 7 days of starting the study.
  • Cannot stop H2 blockers or proton-pump inhibitors.
  • Are taking sorivudine or similar drugs.
  • Have a history of jaw bone problems.

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