Special MRI for Prostate Cancer

Palo Alto (17 mi)

Overseen byIvan de Kouchkovsky, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Ivan de Kouchkovsky, MD

Stay on your current meds

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This study will evaluate the use of hyperpolarized 13C MRI (HP 13C MRI) and the HP-derived 13C pyruvate-to-lactate conversion rate constant (kPL) as an early response biomarker in men with treatment-naïve, high-risk, localized or locally advanced prostate cancer receiving neoadjuvant therapy.

Eligibility Criteria

Men with high-risk, localized or locally advanced prostate cancer who haven't had treatment yet can join this trial. They'll be tested using a special type of MRI to see how well their cancer responds to a new therapy before having surgery.

Inclusion Criteria

I am 18 years old or older.

My scans show no cancer spread far from the original site.

I had hepatitis C but have been treated and cured.

My prostate cancer diagnosis was confirmed through a biopsy, and the sample is available for further testing.

I am scheduled for surgery to remove my prostate and possibly lymph nodes.

I am fully active or can carry out light work.

My prostate cancer is high-risk based on its grade, spread to pelvic nodes, or tumor stage.

Exclusion Criteria

I have previously undergone treatment for prostate cancer.

I am not taking strong medications that affect liver enzymes.

I cannot have gadolinium contrast due to health reasons.

Treatment Details

The study is testing if a special MRI scan called HP 13C MRI can show early on if the cancer treatment is working. Men in the trial will take Abiraterone and Prednisone before getting their prostates removed surgically.

1Treatment groups

Experimental Treatment

Group I: Treatment (Abiraterone/Prednisone, Hyperpolarized (HP) 13C Pyruvate)Experimental Treatment6 Interventions

Neoadjuvant abiraterone (1000mg) will be administered for three 28-day cycles, in conjunction with 5mg of prednisone. Participants will undergo a paired multi-parametric/hyperpolarized MRI of the prostate at screening, cycle 2 day 1, and after completion of neoadjuvant therapy. With each scan, a hyperpolarized 13C-pyruvate injection will be administered. A planned, non-investigational RP will be completed within 7-56 days after last dose/discontinuation of neoadjuvant study drug. Participants will be followed up until death, withdrawal of consent, or end of study, whichever occurs first.

Abiraterone acetate is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Zytiga for: