for people ages 18 years and up (full criteria)
at San Francisco, California
study started
completion around
Principal Investigator
by Ivan de Kouchkovsky, MD



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.

Official Title

Hyperpolarized (HP) 13C Pyruvate Magnetic Resonance Imaging (MRI) as a Response Monitoring Tool in Patients With High-Risk Prostate Cancer Receiving Neoadjuvant Therapy



  1. To investigate on-treatment changes in HP 13C MRI derived kPL as an early response biomarker in men with high-risk localized or locally advanced prostate cancer receiving neoadjuvant abiraterone/prednisone prior to radical prostatectomy (RP).


  1. To evaluate the pathologic complete response/minimal residual disease rate at the time of radical prostatectomy following 12 weeks of neoadjuvant abiraterone/prednisone in patients with high-risk localized or locally advanced prostate cancer.

II. To determine the safety and tolerability of neoadjuvant abiraterone/prednisone in patients with high-risk localized or locally advanced prostate cancer planning to undergo radical prostatectomy (RP).

III. To assess time to biochemical recurrence following radical prostatectomy after 12 weeks of neoadjuvant abiraterone/prednisone IV. To assess prostate-specific antigen (PSA) response to neoadjuvant abiraterone/prednisone prior to RP.


  1. To assess the diagnostic performances of PSMA PET, multiparametric MRI (mpMRI) and hyperpolarized 13C MRI (HP13C MRI) for pathological response at the time of RP II. To investigate the association between early changes in intratumoral metabolism (HP 13C derived pyruvate-to-lactate conversion rate kPL) on neoadjuvant abiraterone with PSA nadir. III. To evaluate associations between baseline genomic and transcriptional features, changes in intratumoral kPL, and pathologic response at the time of radical prostatectomy.


Participants will receive 12 weeks of neoadjuvant abiraterone/prednisone. After completion of neoadjuvant therapy, participants will proceed to radical prostatectomy. Participants will be followed for up to 5 years every 3 months for the first year following RP, then every 6 months until death, biochemical recurrence or initiation of additional prostate cancer directed therapy.


High Risk Prostate Carcinoma, Prostate Cancer, Prostatic Neoplasms, Prednisone, Abiraterone Acetate, Hyperpolarized [1-13C] pyruvate (HP 13C), Magnetic Resonance Imaging (MRI), Non-investigational radical prostatectomy (RP), Prostate-Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) PET/Computerized tomography (CT)


You can join if…

Open to people ages 18 years and up

  1. Greater than or equal to 18 years of age
  2. Histologically confirmed adenocarcinoma of the prostate with archival biopsy tissue available for genomic profiling.
  3. High-risk disease defined as meeting 1 or more of the 3 following criteria:
    1. Gleason grade group >=4; or
    2. Pelvic node involvement by conventional imaging or PSMA PET imaging (cN1); or
    3. 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.
  4. No evidence of distant metastatic disease as determined by PSMA PET/CT or PET/MR. Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.
  5. 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.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  7. Participant must agree to use a condom (even men with vasectomies) and another effective method of birth control if having sex with a woman of childbearing potential or must agree to use a condom if having sex with a woman who is pregnant while on study drug and for 8 weeks following the last dose of study drug. Participant must also agree not to donate sperm during the study and for 8 weeks after receiving the last dose of study drug.
  8. Demonstrates adequate organ function as defined below
    1. Absolute neutrophil count (ANC) >=1,500/microliter (mcL)
    2. Platelets >=100,000/mcL, independent of transfusions/growth factors within 3 months of treatment start
    3. Total bilirubin within normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits
    4. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) <=3 X institutional upper limit of normal
    5. Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) <=3 X institutional upper limit of normal
  9. Ability to understand and the willingness to sign a written informed consent document.

    10. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral

    therapy with undetectable viral load within 6 months are eligible for this trial.

    11. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV

    viral load must be undetectable on suppressive therapy, if indicated.

    12. Individuals with a history of hepatitis C virus (HCV) infection must have been treated

    and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

    13. Individuals with a prior or concurrent malignancy whose natural history or treatment

    does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

    14. Abiraterone may cause fetal harm when administered to a pregnant woman. The effects of

    hyperpolarized [1-13C]pyruvate on the developing human fetus are unknown. For this reason, men treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation and for 8 weeks after last administration of study treatment.

You CAN'T join if...

  1. Patients unwilling or unable to undergo MR imaging, including patients with contraindications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
  2. Patients who cannot tolerate or have contra-indications to endorectal coil insertion; for example, patients with a prior abdominoperineal resection of the rectum or latex allergy. This requirement may be waived at the discretion of the Principal Investigator upon review of available imaging with radiology.
  3. Patients with contra-indications to injection of gadolinium contrast; for example patients with prior documented allergy or those with inadequate renal function.
  4. Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging.
  5. Has received prior prostate cancer therapy.
    1. Prior 5-alpha reductase inhibitors (e.g. finasteride, dutasteride) allowed if discontinued at least 3 weeks prior to first dose.
  6. 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.
  7. 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).


  • UCSF
    San Francisco California 94143 United States

Lead Scientist at UCSF


not yet accepting patients
Start Date
Completion Date
Ivan de Kouchkovsky, MD
Phase 2 research study
Study Type
Expecting 32 study participants
Last Updated