Hyperpolarized (HP) 13C Pyruvate Magnetic Resonance Imaging (MRI) for Response Monitoring to Neoadjuvant Abiraterone
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
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
Treatments tested in this trial
- Abiraterone acetate
- Prednisone
- 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)
Treatment groups
32 Participants
are divided into 1 treatment groupSponsors and collaborators
Ivan de Kouchkovsky, MD
Lead sponsor
University of California, San Francisco
Sponsor institution
Source ClinicalTrials.gov