Study on Using Hyperpolarized 13C MRI to Monitor Response to Abiraterone Treatment in Prostate Cancer

Sponsor: Ivan de Kouchkovsky, MD

Sponsor score: 0

ClinicalTrials ID:NCT06384222

Provider View

This clinical trial is exploring the use of a special type of MRI scan, called hyperpolarized 13C MRI, to see if it can help monitor how well a new treatment works in men with high-risk prostate cancer before surgery.

Patient Parameters

Program Overview

The study aims to find out if hyperpolarized 13C MRI can be used as an early indicator of how well prostate cancer is responding to treatment with abiraterone and prednisone before surgery. This type of MRI measures how quickly a substance called pyruvate is converted to lactate in the body, which may indicate how the cancer is reacting to the treatment.

Description

The main goal of this study is to see if changes in a special MRI scan can show early signs of how well prostate cancer is responding to treatment with abiraterone and prednisone before surgery. Researchers will also look at how many patients have no remaining cancer or very little cancer left after 12 weeks of treatment. They will check the safety of the treatment and how long it takes for the cancer to come back after surgery. The study will also measure changes in PSA levels, a marker used to monitor prostate cancer.

Participants will receive 12 weeks of treatment with abiraterone and prednisone before having surgery to remove the prostate. After surgery, they will be monitored every 3 months for the first year, and then every 6 months for up to 5 years, or until the cancer returns or further treatment is needed.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older.
  • Diagnosed with high-risk prostate cancer, confirmed by a biopsy.
  • Cancer must meet at least one of the following criteria:
    • High Gleason score (grade group 4 or higher).
    • Cancer has spread to pelvic lymph nodes.
    • Cancer has extended outside the prostate or to nearby tissues.
  • No evidence of cancer spread to distant parts of the body.
  • Planning to have surgery to remove the prostate.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Adequate blood cell counts and organ function.
  • Able to understand and sign a consent form.
  • HIV-positive individuals on effective treatment with undetectable viral load are eligible.
  • Hepatitis B or C infections must be under control or treated.
  • Men must agree to use contraception during the study and for 8 weeks after the last treatment.

Exclusion Criteria

  • Unable or unwilling to have an MRI scan.
  • Cannot tolerate certain MRI procedures, such as endorectal coil insertion.
  • Allergic to MRI contrast agents or have poor kidney function.
  • Have metal implants that interfere with MRI scans.
  • Poorly controlled high blood pressure.
  • Heart failure or significant heart problems.
  • Have had a heart attack within the last 6 months.
  • Have received previous prostate cancer treatment, except for certain medications stopped 3 weeks before the study.
  • Currently taking other experimental treatments or medications that affect the study drugs.

Locations

FACILITYZIPCITYSTATE
University of California, San Francisco94143San FranciscoCalifornia

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.