NCT03933670 Hyperpolarized Pyruvate (13C) MR Imaging in Monitoring Patients With Prostate Cancer on Active Surveillance
| NCT ID | NCT03933670 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, San Francisco |
| Condition | Prostate Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2018-07-18 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2018-07-18 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This phase II trial studies the side how well hyperpolarized carbon C 13 pyruvate (HP C-13 pyruvate) magnetic resonance imaging (MRI) works in monitoring patients with prostate cancer on active surveillance who have not received treatment. Diagnostic procedures, such as MRI, may help visualize HP C-13 pyruvate uptake and breakdown in tumor cells.
Eligibility Criteria
Inclusion Criteria: * The subject has biopsy-proven adenocarcinoma of the prostate with low to intermediate risk disease by UCSF-CAPRA scoring at study entry. * For Part 1: Patient planning to enroll or currently on active surveillance; For Part 2: Currently enrolled on active surveillance with planned fusion biopsy within 12 weeks following completion of baseline HP C-13 pyruvate/mpMRI on study. * The subject is able and willing to comply with study procedures and provide signed and dated informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Absolute neutrophil count (ANC) \>= 1000 cells/microliter (uL). * Hemoglobin \>= 9.0 gm/deciliter (dL). * Platelets \>= 75,000 cells/uL. * Estimated creatinine clearance\* \>= 50 milliliter (mL)/min by the Cockcroft Gault equation. * Total bilirubin =\< 1.5 x upper limit of normal (ULN) or if =\< 3 x ULN if known/suspected Gilbert's * Aspartate aminotransferase (AST) =\< 1.5 x ULN. * Alanine aminotransferase (ALT) =\< 1.5 x ULN. Exclusion Criteria: * Patients without evidence of any prostate cancer on most recent prostate biopsy performed prior to study entry. * Current or prior androgen deprivation therapy including luteinizing hormone-releasing hormone (LHRH) analogue or oral anti-androgen therapy. Previous use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least 28 days prior to baseline C-13 HP pyruvate MRI * Prior radiation treatment of the prostate. * Prostate biopsy performed within 14 days prior to baseline C-13 HP pyruvate MRI. * Poorly controlled hypertension, with blood pressure at study entry \> 160 mm Hg systolic or \> 100 mmg Hg diastolic. Treatment with anti-hypertensives and re-screening is permitted. * Congestive heart failure with New York Heart Association (NYHA) status \>= 2.
Contact & Investigator
Ivan de Kouchkovsky, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT03933670 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03933670 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03933670 currently recruiting?
Yes, NCT03933670 is actively recruiting participants. Contact the research team at Louise.Magat@ucsf.edu for enrollment information.
Where is the NCT03933670 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT03933670 clinical trial?
NCT03933670 is sponsored by University of California, San Francisco. The principal investigator is Ivan de Kouchkovsky, MD at University of California, San Francisco. The trial plans to enroll 60 participants.