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

ConditionsHigh Risk Prostate CarcinomaProstate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIvan de Kouchkovsky, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Gleason grade group >=4; or

Pelvic node involvement by conventional imaging or PSMA PET imaging (cN1); or

Disqualifiers

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 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. The use of an endorectal coil may be waived at the discretion of the Principal Investigator upon review of available imaging with radiology, in which case this exclusion criteria will not apply.

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Abiraterone acetate

    Drug

    Given orally

  • Prednisone

    Drug

    Given orally

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

    Drug

    Given IV

  • Magnetic Resonance Imaging (MRI)

    Procedure/Surgery

    Imaging procedure

  • Non-investigational radical prostatectomy (RP)

    Procedure/Surgery

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

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

    Procedure/Surgery

    Imaging procedure

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Treatment (Abiraterone/Prednisone, Hyperpolarized (HP) 13C Pyruvate)Experimental treatment 6 interventions

Trial outcomes

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.

Time frame
Up to 4 weeks

Secondary outcomes

1

Pathological response rate

Pathological response rate is defined as the rate of combined pathological complete response (pCR) or minimal residual disease (MRD) at radical prostatectomy (RP). The point estimate and 95% confidence intervals will be reported. A pCR is defined as the absence of tumor on the gross specimen o MRD is defined as residual tumors with cross-sectional diameter of \<=0.5cm.

Time frame
Up to 3 months
2

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

Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5 criteria. Proportion of participants reporting treatment-related adverse events will be reported.

Time frame
Up to 3 months
3

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

Proportion of patients successfully undergoing planned, non-interventional RP following neoadjuvant therapy will be reported.

Time frame
Up to 8 weeks following completion of neoadjuvant treatment.
4

Median Time to Biochemical Recurrence

The Kaplan-Meier method will be used to estimate the median time to biochemical recurrence (along with 95% confidence intervals). Biochemical recurrence will be defined as a serum PSA \>=0.2 ng/mL confirmed on two separate occasions (with time of biochemical recurrence defined as the date of the first serum PSA \>=0.2 ng/mL). Participants deceased or initiated on a prostate cancer (PC)-directed therapy prior to biochemical recurrence will be censored at the time of death or initiation of PC-directed therapy. Similarly, participants removed from the trial prior to biochemical recurrence will be censored at the time of study removal.

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ivan de Kouchkovsky, MD

Lead sponsor

University of California, San Francisco

Sponsor institution

Source ClinicalTrials.gov
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