← Back to Search

Hormone Therapy

Special MRI for Prostate Cancer

Phase 2

Waitlist Available

Research Sponsored by Ivan de Kouchkovsky, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Greater than or equal to 18 years of age

No evidence of distant metastatic disease as determined by PSMA PET/CT or PET/MR

Must not have

Has received prior prostate cancer therapy

Concurrent use of strong CYP3A4 inhibitors or inducers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial will use a special type of MRI scan to look at how quickly a substance is converted in the body of men with aggressive prostate cancer who are receiving treatment for the first time."

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects from Abiraterone include fatigue, joint swelling or discomfort, hot flushes, diarrhea, and urinary tract infection. The MRI procedure itself is generally safe but may cause discomfort due to its duration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

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

Select...

I had hepatitis C but have been treated and cured.

Select...

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

Select...

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

Select...

I am fully active or can carry out light work.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have previously undergone treatment for prostate cancer.

Select...

I am not taking strong medications that affect liver enzymes.

Select...

I cannot have gadolinium contrast due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean changes in intratumoral pyruvate-to-lactate conversion rate constant (kPL)

Secondary study objectives

Mean PSA nadir

Median Time to Biochemical Recurrence

Pathological response rate

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abiraterone acetate

2014

Completed Phase 3

~3440

Prednisone

2014

Completed Phase 4

~2500