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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Greater than or equal to 18 years of age

• Histologically confirmed adenocarcinoma of the prostate with archival biopsy tissue available for genomic profiling.

• 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.

• 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.

• 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.

‣ Estimated creatinine clearance \>=40 mL/min (by the Cockcroft Gault equation).

• Ability to understand and the willingness to sign a written informed consent document.

• Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

⁃ For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

⁃ 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.

⁃ 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.

⁃ 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.

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Maya Aslam
Maya.Aslam@ucsf.edu
(415) 514-8987
Time Frame
Start Date: 2024-12-09
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 32
Treatments
Experimental: Treatment (Abiraterone/Prednisone, Hyperpolarized (HP) 13C Pyruvate)
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. 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.
Related Therapeutic Areas
Sponsors
Leads: Ivan de Kouchkovsky, MD

This content was sourced from clinicaltrials.gov

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