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Hormone Therapy

Treatment (Abiraterone/Prednisone, Hyperpolarized (HP) 13C Pyruvate) 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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I am 18 years old or older.
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My scans show no cancer spread far from the original site.
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I had hepatitis C but have been treated and cured.
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My prostate cancer diagnosis was confirmed through a biopsy, and the sample is available for further testing.
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I am scheduled for surgery to remove my prostate and possibly lymph nodes.
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I am fully active or can carry out light work.
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My prostate cancer is high-risk based on its grade, spread to pelvic nodes, or tumor stage.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean changes in intratumoral pyruvate-to-lactate conversion rate constant (kPL)
Secondary outcome measures
Mean PSA nadir
Median Time to Biochemical Recurrence
Pathological response rate
+4 more

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
Magnetic Resonance Imaging (MRI)
2015
Completed Phase 4
~1800
Prednisone
2014
Completed Phase 4
~2370
Abiraterone acetate
2014
Completed Phase 3
~3440

Find a Location

Who is running the clinical trial?

Ivan de Kouchkovsky, MDLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Prostate Cancer
50 Patients Enrolled for Prostate Cancer
~21 spots leftby Jul 2027
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