Trial Title:
Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer
NCT ID:
NCT06391034
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Hormones
Conditions: Keywords:
Imaging Studies
Hyperpolarized 13C-Pyruvate
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
hyperpolarized pyruvate +/-urea (13C/15N)
Description:
Given IV
Arm group label:
Part 1: Image Optimization Group
Arm group label:
Part 2A: Prospective imaging (Stereotactic body radiotherapy (SBRT) Participants)
Arm group label:
Part 2B: Prospective imaging (High-risk localized prostate cancer)
Arm group label:
Part 3: SBRT participants at time of biochemical recurrence (BCR)
Other name:
13C-Pyruvate,15N-urea
Intervention type:
Radiation
Intervention name:
Non-investigational Stereotactic body radiotherapy (SBRT)
Description:
Stereotactic body radiotherapy given outside of this study
Arm group label:
Part 2A: Prospective imaging (Stereotactic body radiotherapy (SBRT) Participants)
Arm group label:
Part 3: SBRT participants at time of biochemical recurrence (BCR)
Other name:
SBRT
Intervention type:
Procedure
Intervention name:
Radiotherapy (RT)
Description:
Radiation therapy given outside of this study
Arm group label:
Part 2B: Prospective imaging (High-risk localized prostate cancer)
Other name:
RT
Intervention type:
Procedure
Intervention name:
Multi-parametric magnetic resonance imaging (mpMRI)
Description:
Imaging scan
Arm group label:
Part 1: Image Optimization Group
Arm group label:
Part 2A: Prospective imaging (Stereotactic body radiotherapy (SBRT) Participants)
Arm group label:
Part 2B: Prospective imaging (High-risk localized prostate cancer)
Arm group label:
Part 3: SBRT participants at time of biochemical recurrence (BCR)
Other name:
mpMRI
Intervention type:
Biological
Intervention name:
Non-interventional hormone therapy
Description:
Therapy given outside of this study as part of standard of care
Arm group label:
Part 2B: Prospective imaging (High-risk localized prostate cancer)
Other name:
Non-interventional, systemic hormone therapy
Intervention type:
Procedure
Intervention name:
Prostate Biopsy
Description:
Biopsies may be taken from Trans-rectal ultrasound (TRUS) -visible lesion at the
urologist's discretion
Arm group label:
Part 3: SBRT participants at time of biochemical recurrence (BCR)
Other name:
Biopsy
Summary:
This is a Phase 2 clinical study of hyperpolarized (HP) 13C-pyruvate (13C), 15N-urea
(13C,15N) metabolic MR imaging in prostate cancer patients who are undergoing or have
received radiation therapy for prostate cancer.
Detailed description:
PRIMARY OBJECTIVES:
I. Part 1: To Optimize the imaging sequences that maximize signal-to-noise ratio (SNR)
and intra-tumoral kPL and kPG in regions of tumor vs. adjacent benign tissue as assessed
by mpMRI imaging characteristics.
II. Part 2A To perform HP 13C-MRI and measure the changes in tumoral kPL and kPG.
III. Part 2B: To perform HP 13C-MRI and study the metabolic effects (changes in tumor kPL
and kPG).
IV. Part 3: To perform HP 13C-MRI at time of Biochemical Failure and measure tumoral kPL
and kPG, in previously SBRT treated patients.
SECONDARY OBJECTIVES:
I. To evaluate the intra-patient variability in intra-tumoral kPL and kPG with repeated
dose studies (Part 1, 2 & 3).
II. To determine the association between peak intra-tumoral kPL observed on baseline
imaging with serum PSA. (Part 2 & 3).
III. To determine the association between changes in intra-tumor kPL after 4-12 weeks of
systemic hormone therapy and PSA response (Part 2B).
IV. To compare and contrast intra-tumoral kPL and kPG with Prostate Imaging Reporting and
Data System (PI-RADS) version 2 and individual mpMRI parameters including apparent
diffusion coefficient (ADC) on diffusion-weighted imaging (Part 1, 2 & 3).
V. To describe the frequency of up-grading of tumor with MR/US-guided fusion biopsy
obtained following baseline HP-MRI exam. (Part 3).
VI. To further characterize the safety profile of HP C-13 pyruvate injections (Part 1, 2
& 3).
VII. For patients imaged with HP 13C-MRI at time of biochemical failure post-SBRT,
correlate peak intra-tumoral kPL and kPG with radiotherapy dose distributions from SBRT
course (Part 3).
VIII. For studies incorporating HP 13C-urea, the baseline and the on-treatment changes in
ureaAUC parameter will be measured and compared to kPL endpoints of the same lesions
(Part 1, 2 & 3).
OUTLINE:
The study is divided into 3 parts. Part 1: Participants undergo imaging as part of a
multi-parametric magnetic resonance imaging (mpMRI) exam to determine exact parameters
for imaging.
Part 2A: Participants planned for stereotactic body radiotherapy (SBRT) Part 2B:
Participants with high-risk localized prostate cancer planned to receive primary
radiation therapy with concurrent systemic hormone therapy Part 3: Evaluable SBRT
participants scanned at time of biochemical failure and MR/US fusion-guided prostate
biopsy within 12 weeks. Participants have the option of undergoing a follow up HP
Pyruvate +/- Urea MR exam 6-15 months following the baseline scan.
All participants will receive a scan at baseline and other procedures may be performed as
part of routine, non-interventional standard of care at the time of biochemical failure,
including serial prostate-specific antigen (PSA) monitoring and gene expression profiling
of tumor tissue. Participants will be followed for 24 months after last procedure or
removal from study, or until death, whichever occurs first.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Participants must have biopsy-proven adenocarcinoma of the prostate, as determined
by medical chart review.
2. For:
1. Part 1: Participants post-radiation therapy or currently considering SBRT.
2. Part 2A: Participants currently scheduled for or considering SBRT (no
neo-adjuvant therapy planned).
3. Part 2B: Participants currently scheduled for or considering SBRT and
neo-adjuvant therapy is planned. The participant has biopsy-proven
adenocarcinoma of the prostate with high-risk disease, defined by the presence
of at least two of following criteria: a tumor stage of T3 or T4, a Gleason
score of 8 to 10, or a PSA level ≥40 ng/mL) and the participant must be
planning to receive androgen deprivation therapy (ADT) with an Luteinizing
hormone-releasing hormone (LHRH) agonist or antagonist. The addition of an
androgen-receptor (AR) signaling inhibitor (e.g., abiraterone,
bicalutamide,apalutamide, enzalutamide or darolutamide) will be allowed.
4. Part 3: Participants who have previously received radiation treatment to the
prostate and are exhibiting signs of biochemical failure, with planned fusion
biopsy within 12 weeks following completion of baseline HP 13C pyruvate +/-urea
mpMRI.
3. Participant is able and willing to comply with study procedures and provide signed
and dated informed consent.
4. Eastern Cooperative Oncology Group (ECOG) performance status <= 1.
5. Age >= 18 years old at time of study entry.
6. Ability to understand and the willingness to sign a written informed consent
document.
7. Demonstrates adequate organ function as defined below:
1. White Blood Cell count (WBC) >=4000 cells/μL.
2. Hemoglobin ≥9.0 gm/dL.
3. Platelets ≥75,000 cells/μL.
4. Renal Function > 30 Epithelial Growth Factor Receptor (eGFR).
Exclusion Criteria:
1. Evidence of pelvic regional or distant metastatic disease on conventional imaging
(MRI, computed tomography or whole body bone scan) or prostate-specific membrane
antigen (PSMA) Positron Emission Tomography (PET) imaging. PSMA-avid lymph nodes
confined to the pelvis will be allowed if <1 centimeter (cm).
2. Prostate biopsy performed within 14 days prior to baseline C-13 HP pyruvate MRI.
3. Poorly controlled hypertension, with blood pressure at study entry > 160 mm Hg
systolic or > 100 mm Hg diastolic. Treatment with anti-hypertensives and
re-screening is permitted.
4. Contraindication to or inability to tolerate MRI with endorectal coil (e.g. severe
claustrophobia, presence of cardiac pacemaker, aneurysm clip, severe or painful
hemorrhoids, rectal stricture).
5. Congestive heart failure with New York Heart Association (NYHA) status >= 2.
6. History of clinically significant ECG abnormality, including QT prolongation, a
family history of prolonged QT interval syndrome or myocardial infarction within 6
months of study entry.
Gender:
Male
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:
Louise Magat
Phone:
415-502-1822
Email:
Louise.Magat@ucsf.edu
Contact backup:
Phone:
877-827-3222
Email:
cancertrials@ucsf.edu
Investigator:
Last name:
Robert Bok, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Anthony Wong, MD, PhD
Email:
Sub-Investigator
Start date:
June 1, 2024
Completion date:
June 30, 2032
Lead sponsor:
Agency:
Robert Bok, MD, PhD
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
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/NCT06391034
