Trial Title:
Hyperpolarized (HP) 13C Pyruvate Magnetic Resonance Imaging (MRI) for Response Monitoring to Neoadjuvant Abiraterone
NCT ID:
NCT06384222
Condition:
High Risk Prostate Carcinoma
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Prednisone
Abiraterone Acetate
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Abiraterone acetate
Description:
Given orally
Arm group label:
Treatment (Abiraterone/Prednisone, Hyperpolarized (HP) 13C Pyruvate)
Other name:
Abiraterone
Other name:
Zytiga
Intervention type:
Drug
Intervention name:
Prednisone
Description:
Given orally
Arm group label:
Treatment (Abiraterone/Prednisone, Hyperpolarized (HP) 13C Pyruvate)
Other name:
Rayos
Intervention type:
Drug
Intervention name:
Hyperpolarized [1-13C] pyruvate (HP 13C)
Description:
Given IV
Arm group label:
Treatment (Abiraterone/Prednisone, Hyperpolarized (HP) 13C Pyruvate)
Other name:
Hyperpolarized 13C
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging (MRI)
Description:
Imaging procedure
Arm group label:
Treatment (Abiraterone/Prednisone, Hyperpolarized (HP) 13C Pyruvate)
Other name:
MRI
Other name:
MR
Intervention type:
Procedure
Intervention name:
Non-investigational radical prostatectomy (RP)
Description:
Planned, standard of care surgical procedure occurring outside of this study.
Arm group label:
Treatment (Abiraterone/Prednisone, Hyperpolarized (HP) 13C Pyruvate)
Other name:
Radical prostatectomy
Intervention type:
Procedure
Intervention name:
Prostate-Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) PET/Computerized tomography (CT)
Description:
Imaging procedure
Arm group label:
Treatment (Abiraterone/Prednisone, Hyperpolarized (HP) 13C Pyruvate)
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.
Detailed description:
PRIMARY OBJECTIVE:
I. 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).
SECONDARY OBJECTIVES:
I. 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.
EXPLORATORY OBJECTIVES:
I. To assess the diagnostic performances of 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.
OUTLINE:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
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 2.
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.
6. Estimated creatinine clearance >=40 mL/min (by the Cockcroft Gault equation).
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.
Exclusion Criteria:
1. Participants unwilling or unable to undergo MR imaging, including patients with
contraindications to MRI, such as cardiac pacemakers or non-compatible intracranial
vascular clips.
2. 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.
3. Participants with contra-indications to injection of gadolinium contrast; for
example, participants 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. Poorly controlled hypertension, with blood pressure at study entry >160 mmHg
systolic or >100 mmHg diastolic.
6. Congestive heart failure with New York Heart Association (NYHA) status >=2.
7. 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.
8. 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.
9. 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.
10. 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Contact:
Last name:
Maya Aslam
Phone:
(415) 514-8987
Email:
Maya.Aslam@ucsf.edu
Contact backup:
Phone:
877-827-3222
Email:
cancertrials@ucsf.edu
Contact backup:
Last name:
Ivan de Kouchkovsky, MD
Start date:
September 30, 2024
Completion date:
July 31, 2027
Lead sponsor:
Agency:
Ivan de Kouchkovsky, MD
Agency class:
Other
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06384222
