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New treatment option for Prostate Adenocarcinoma
Official title Hyperpolarized Pyruvate (13C) MR Imaging in Monitoring Patients With Prostate Cancer on Active Surveillance
ClinicalTrials.gov ID: NCT03933670
What this study is testing
What is Hyperpolarized Carbon C 13 Pyruvate?
Hyperpolarized Carbon C 13 Pyruvate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prostate adenocarcinoma.
Also referred to as Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- 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).
You likely can't join if
- 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...
- 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...
- Congestive heart failure with New York Heart Association (NYHA) status \>= 2.
See the full eligibility 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.