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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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean changes in intratumoral 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

Abiraterone acetate

2014

Completed Phase 3

~3440

Prednisone

2014

Completed Phase 4

~2370

0 / 7Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the safety profile of Abiraterone/Prednisone and Hyperpolarized (HP) 13C Pyruvate treatment for individuals?

"Given that this is a Phase 2 trial with some evidence backing its safety but lacking efficacy data, Treatment (Abiraterone/Prednisone, Hyperpolarized (HP) 13C Pyruvate) received a rating of 2 on our safety scale from Power."

Answered by AI

Are there any ongoing efforts to enroll participants in this clinical trial at the moment?

"According to details from clinicaltrials.gov, recruitment for this specific trial is currently closed. Although it was initially listed on 30th June 2024 and last updated on 22nd April 2024. Despite its closure, there are a total of 1391 ongoing studies actively seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hyperpolarized (HP) 13C Pyruvate Magnetic Resonance Imaging (MRI) MRI as a Response Monitoring Tool to Neoadjuvant Abiraterone

Ivan de Kouchkovsky, MD 2024. "Hyperpolarized (HP) 13C Pyruvate Magnetic Resonance Imaging (MRI) MRI as a Response Monitoring Tool to Neoadjuvant Abiraterone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06384222.

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