RECRUITING

Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer

Conditions

Prostate Cancer Imaging Studies Hyperpolarized 13C-Pyruvate

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2 Study of Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer Undergoing Radiation Therapy

Quick Facts

Study Start:2024-09-24

Study Completion:2032-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06391034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	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.

Inclusion Criteria

Exclusion 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).

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.

Contacts and Locations

Study Contact

Louise Magat

CONTACT

(415) 502-1822

Louise.Magat@ucsf.edu

Principal Investigator

Robert Bok, MD, PhD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: Robert Bok, MD, PhD

Robert Bok, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-24

Study Completion Date2032-10-31

Study Record Updates

Study Start Date2024-09-24

Study Completion Date2032-10-31

Terms related to this study

Keywords Provided by Researchers

Imaging Studies
Hyperpolarized 13C-Pyruvate

Additional Relevant MeSH Terms

Prostate Cancer