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

NCT06384222 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 235513NCI-2024-03418
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

High Risk Prostate Carcinoma; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

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

  Mean changes in intratumoral kPL from baseline to 4 weeks will be reported. For participants with \>1 intraprostatic lesions detected on baseline scan, change in kPL will be calculated on using the lesion with the highest initial kPL.

  Up to 4 weeks

Secondary Outcomes (7)

• Pathological response rate

  Up to 3 months

• Proportion of participants with treatment-related adverse events (TRAE)

  Up to 3 months

• Proportion of participants completing non-interventional radical prostatectomy (RP)

  Up to 8 weeks following completion of neoadjuvant treatment.

• Median Time to Biochemical Recurrence

  Up to 5 years

• Proportion of participants with a >=50% decline in PSA level from baseline (PSA50) response

  Up to 4 months

Study Arms (1)

Treatment (Abiraterone/Prednisone, Hyperpolarized (HP) 13C Pyruvate)

EXPERIMENTAL

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 and an endorectal coil will be inserted prior to and removed after completion of the 1H and 13C MR exam using standard institutional procedures for preparation and placement for enhanced imaging. 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.

Drug: Abiraterone acetate; Drug: Prednisone; Drug: Hyperpolarized [1-13C] pyruvate (HP 13C); Procedure: Magnetic Resonance Imaging (MRI); Procedure: Non-investigational radical prostatectomy (RP); Procedure: Prostate-Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) PET/Computerized tomography (CT)

Interventions

Abiraterone acetate DRUG

Given orally

Also known as: Abiraterone

Treatment (Abiraterone/Prednisone, Hyperpolarized (HP) 13C Pyruvate)

Prednisone DRUG

Given orally

Also known as: Rayos

Treatment (Abiraterone/Prednisone, Hyperpolarized (HP) 13C Pyruvate)

Hyperpolarized [1-13C] pyruvate (HP 13C) DRUG

Given IV

Also known as: Hyperpolarized 13C

Treatment (Abiraterone/Prednisone, Hyperpolarized (HP) 13C Pyruvate)

Magnetic Resonance Imaging (MRI) PROCEDURE

Imaging procedure

Also known as: MRI, MR

Treatment (Abiraterone/Prednisone, Hyperpolarized (HP) 13C Pyruvate)

Non-investigational radical prostatectomy (RP) PROCEDURE

Planned, standard of care surgical procedure occurring outside of this study.

Also known as: Radical prostatectomy

Treatment (Abiraterone/Prednisone, Hyperpolarized (HP) 13C Pyruvate)

Prostate-Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) PET/Computerized tomography (CT) PROCEDURE

Imaging procedure

Treatment (Abiraterone/Prednisone, Hyperpolarized (HP) 13C Pyruvate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than or equal to 18 years of age
• Histologically confirmed adenocarcinoma of the prostate with archival biopsy tissue (collected within 12 months of cycle 1 day 1 of treatment) available for genomic profiling.
• a. Tumor tissue does not need to be retrieved but rather identified and available upon later request for future pathologic review and possible correlative studies.
• High-risk disease defined as meeting 1 or more of the 3 following criteria:
• Gleason grade group \>=4; or
• Pelvic node involvement by conventional imaging or PSMA PET imaging (cN1); or
• Tumor stage T3 or higher (i.e. tumor extension outside of the prostate, or spread to tissues near the prostate other than the seminal vesicles, such as the bladder or wall of the pelvis) as determined by conventional imaging (including prostate MRI), transrectal ultrasound or PSMA PET imaging.
• Participants must be planning to undergo radical prostatectomy (RP) with or without pelvic lymph node dissection and considered surgically resectable by urologic evaluation at the time of study entry. Adjuvant therapy following RP will be allowed per treating provider discretion.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Demonstrates adequate organ function as defined below:
• Absolute neutrophil count (ANC) \>=1,500/microliter (mcL).
• Platelets \>=100,000/mcL, independent of transfusions/growth factors within 3 months of treatment start.
• Total bilirubin within normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits.
• Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) \<=3 X institutional upper limit of normal.
• Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) \<=3 X institutional upper limit of normal.

You may not qualify if:

• Participants unwilling or unable to undergo MR imaging, including patients with contraindications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
• Participants with contra-indications to injection of gadolinium contrast; for example, participants with prior documented allergy or those with inadequate renal function.
• Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging.
• Poorly controlled hypertension, with blood pressure at study entry \>160 mmHg systolic or \>100 mmHg diastolic.
• Congestive heart failure with New York Heart Association (NYHA) status \>=2.
• A history of clinically significant EKG abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction within 6 months of study entry.
• Has received prior prostate cancer therapy.
• a. Prior 5-alpha reductase inhibitors (e.g. finasteride, dutasteride) allowed if discontinued at least 3 weeks prior to first dose.
• Is currently receiving any other investigational agent(s) or has participated in a study of an investigational product and received study treatment or used an investigational device within 2 weeks of the first dose of treatment.
• Concurrent use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole,clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole) or inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital).

Sponsors & Collaborators

• Ivan de Kouchkovsky, MD: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; abiraterone; Prednisone; Pyruvic Acid; Magnetic Resonance Spectroscopy; Glutamate Carboxypeptidase II; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Pyruvates; Keto Acids; Carboxylic Acids; Organic Chemicals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Carboxypeptidases; Exopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloexopeptidases; Metalloproteases

Study Officials

• Ivan de Kouchkovsky, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Aslam

CONTACT

(415) 514-8987; Maya.Aslam@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)