Actively Recruiting
Hyperpolarized (HP) 13C Pyruvate Magnetic Resonance Imaging (MRI) for Response Monitoring to Neoadjuvant Abiraterone
Led by Ivan de Kouchkovsky, MD · Updated on 2025-12-30
32
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hyperpolarized (HP) 13C Pyruvate Magnetic Resonance Imaging (MRI) for Response Monitoring to Neoadjuvant Abiraterone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Histologically confirmed adenocarcinoma of the prostate with biopsy tissue available for genomic profiling collected within 12 months before treatment
- High-risk disease defined by one or more: Gleason grade group 64; pelvic node involvement by imaging (cN1); or tumor stage T3 or higher as determined by imaging
- No distant metastatic disease by PSMA PET/CT or PET/MR; nodal disease below iliac bifurcation (clinical stage N1) allowed
- Planning to undergo radical prostatectomy with or without pelvic lymph node dissection and considered surgically resectable
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate organ function including neutrophil count 61,500/mcL, platelets 61,000,000/mcL, normal bilirubin or Gilbert's syndrome, AST/SGOT and ALT/SGPT 63 times upper normal limit, and creatinine clearance 640 mL/min
- Ability and willingness to provide informed consent
- HIV-infected individuals on effective therapy with undetectable viral load within 6 months
- For chronic hepatitis B infection, undetectable viral load on suppressive therapy if needed
- Individuals with hepatitis C infection must be cured or have undetectable viral load if on treatment
- Prior or concurrent malignancy allowed if it does not interfere with safety or efficacy assessment
- Agree to use adequate contraception during the study and for 8 weeks after last treatment
You will not qualify if you...
- Unable or unwilling to undergo MRI imaging, including contraindications like pacemakers or incompatible vascular clips
- Cannot tolerate or contraindicated for endorectal coil insertion unless waived by investigator
- Contraindications to gadolinium contrast injection such as allergy or poor kidney function
- Presence of metallic hip or other implants that distort MRI quality
- Poorly controlled hypertension with blood pressure above 160/100 mmHg at entry
- Congestive heart failure with NYHA status of 2 or higher
- History of significant EKG abnormalities, prolonged QT syndrome, or recent myocardial infarction within 6 months
- Prior prostate cancer therapy received (except 5-alpha reductase inhibitors stopped at least 3 weeks before treatment)
- Currently receiving other investigational agents or used investigational products within 2 weeks before treatment
- Concurrent use of strong CYP3A4 inhibitors or inducers such as ketoconazole, phenytoin, rifampin, and others listed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
M
Maya Aslam
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here