Prostate CancerEarly Phase 1NCT02450201
MRI With C13 Pilot Study Prostate Cancer
A Early Phase 1 study testing Pyruvate in people with Prostate Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a pilot clinical study of hyperpolarized pyruvate (13C) injection that includes the acquisition of magnetic resonance (MR) data and will be performed in men with localized prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Pyruvate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2016to 17 Jan 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has biopsy-proven adenocarcinoma of the prostate with intermediate to high risk disease by UCSF CAPRA scoring and possesses a Gleason 4 component to the tumor. Subjects will be enrolled either prior to radical prostatectomy (N=5) or prior to 2 months of androgen deprivation therapy (LHRH agonist +/- antiandrogen) followed by definitive radiation therapy as their primary treatment for prostate cancer (N=5).
- The subject is able and willing to comply with study procedures and provide signed and dated informed consent.
- At least 5 mm of tumor on biopsy (can have multiple cores to comprise 5 mm).
- The subject has concordant MRI/1H MRSI findings from a MR staging exam at UCSF performed prior to the 13C MRSI exam performed in this study with IMP, or is willing to undergo MRI/1H MRSI in connection with the study exam.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Laboratory criteria for protocol entry:
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- Absolute neutrophil count (ANC) ≥1000 cells/µL
- Hemoglobin ≥9.0 gm/dL
- Platelets ≥75,000 cells/µL
- Estimated creatinine clearance ≥50 mL/min
- Total bilirubin ≤1.5x ULN (or if ≤4 gm/dL and direct bilirubin is WNL)
- Aspartate aminotransferase (AST) ≤1.5x ULN
- Alanine aminotransferase (ALT) ≤1.5x ULN
- Willing to use contraception during and for 1 month after completion of the study.
- For part 2 of the study: plans to initiate castrating therapy (with a GnRH antagonist, GnRH agonist, or orchiectomy). An antiandrogen may be started after initial imaging but can not be used prior to baseline imaging. An antiandrogen is allowed but not required.
Who cannot join
- The subject has received, or is scheduled to receive, another IMP from 1 month before to 1 month after inclusion in this study.
- Current or prior androgen deprivation therapy; previous use of a 5-α reductase inhibitor is allowed, provided it was discontinued at least one month prior to study entry.
- Poorly controlled hypertension, with blood pressure at study entry>160/100.
- Contraindication for or inability to tolerate MRI examination.
- Prostate biopsy within 12 weeks prior to study entry.
- BMI of less than 18.5 or greater than 32. Subject body weight should be less than or equal to 100 kg owing to limitations in the amount of IMP available.
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- Congestive heart failure or New York Heart Association (NYHA) status≥2.
- A history of clinically significant EKG abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) less than 1 year ago with ensuing unstable EKG.
- Ongoing acute or chronic pulmonary bronchospastic disease, including a history of chronic obstructive pulmonary disease or asthma, with an exacerbation within the past year.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: A Pilot Study to Evaluate the Reproducibility of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) and Its Ability to Reflect Treatment Effects in Patients With Prostate Cancer
This is a pilot clinical study of hyperpolarized pyruvate (13C) injection that includes the acquisition of magnetic resonance (MR) data and will be performed in men with localized prostate cancer. Part 1: Five patients will be evaluated for reproducibility of 13C HP MR imaging measurements obtained 2-3 weeks apart with no interim treatment. Part 2: Five patients will be evaluated for the change in 13C HP MR imaging measurements after 2 months of ADT.
13C HP MR data will be acquired in two parts of the study (which can occur simultaneously): Part 1: Patients will undergo imaging at baseline and will be repeated two to three weeks later (with no intervention in the interim) to evaluate reproducibility.
Read more
Part 2: Patients will undergo imaging at baseline, initiate androgen deprivation therapy, and undergo repeat imaging two months after initiation of ADT to evaluate the ability of the imaging to reflect a metabolic response to treatment.
The change in pyruvate/lactate ratio and lactate levels will be measured and compared to baseline at these timepoints.
- Conditions
- Prostate Cancer
- Being tested
- Pyruvate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyruvateDrug
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Reproducibility | Experimental | Pyruvate injection followed by an MRI scan. 2-3 weeks after imaging #1: a second pyruvate injection followed by an MRI scan. Receives: Drug: Pyruvate |
| Part 2: Treatment Response | Experimental | Pyruvate injection followed by an MRI scan. 2 months after imaging #1: a second pyruvate injection followed by an MRI scan. Receives: Drug: Pyruvate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in peak lactate/pyruvate ratio
Measured: Baseline and 2-3 weeks after 1st image
Difference in peak lactate/pyruvate ratio
Measured: Baseline and 2 months after 1st image
Secondary outcomes (5)
Pyruvate area under the curve (AUC)
Measured: Baseline and 2-3 weeks after 1st image
Lactate area under the curve (AUC)
Measured: Baseline and 2-3 weeks after 1st image
Pyruvate area under the curve (AUC)
Measured: Baseline and 2 months after 1st image
Lactate area under the curve (AUC)
Measured: Baseline and 2 months after 1st image
Safety As measured by Adverse Events
As measured by Adverse Events
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study start12 Oct 2016
- Primary completion17 Jan 2017
- Study completion17 Jan 2017
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahul Aggarwal, University of California, San Francisco
- Investigators
- Rahul Aggarwal, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450201
- Sponsor's protocol ID
- 125518
- Status last verified
- Oct 2018
- First submitted
- 18 May 2015
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Reproducibility of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) and Its Ability to Reflect Treatment Effects in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT02450201
- Acronym / sponsor ID
- 125518
- Conditions
- Prostate Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 12 Oct 2016 (actual)
- Primary completion
- 17 Jan 2017 (actual)
- Study completion
- 17 Jan 2017 (actual)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot clinical study of hyperpolarized pyruvate (13C) injection that includes the acquisition of magnetic resonance (MR) data and will be performed in men with localized prostate cancer. Part 1: Five patients will be evaluated for reproducibility of 13C HP MR imaging measurements obtained 2-3 weeks apart with no interim treatment. Part 2: Five patients will be evaluated for the change in 13C HP MR imaging measurements after 2 months of ADT.
13C HP MR data will be acquired in two parts of the study (which can occur simultaneously): Part 1: Patients will undergo imaging at baseline and will be repeated two to three weeks later (with no intervention in the interim) to evaluate reproducibility.
Part 2: Patients will undergo imaging at baseline, initiate androgen deprivation therapy, and undergo repeat imaging two months after initiation of ADT to evaluate the ability of the imaging to reflect a metabolic response to treatment.
The change in pyruvate/lactate ratio and lactate levels will be measured and compared to baseline at these timepoints.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Reproducibility | Experimental | Drug: PyruvatePyruvate injection followed by an MRI scan. 2-3 weeks after imaging #1: a second pyruvate injection followed by an MRI scan. |
| Part 2: Treatment Response | Experimental | Drug: PyruvatePyruvate injection followed by an MRI scan. 2 months after imaging #1: a second pyruvate injection followed by an MRI scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The subject has biopsy-proven adenocarcinoma of the prostate with intermediate to high risk disease by UCSF CAPRA scoring and possesses a Gleason 4 component to the tumor. Subjects will be enrolled either prior to radical prostatectomy (N=5) or prior to 2 months of androgen deprivation therapy (LHRH agonist +/- antiandrogen) followed by definitive radiation therapy as their primary treatment for prostate cancer (N=5).
- The subject is able and willing to comply with study procedures and provide signed and dated informed consent.
- At least 5 mm of tumor on biopsy (can have multiple cores to comprise 5 mm).
- The subject has concordant MRI/1H MRSI findings from a MR staging exam at UCSF performed prior to the 13C MRSI exam performed in this study with IMP, or is willing to undergo MRI/1H MRSI in connection with the study exam.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Key exclusion criteria (9 listed)
- The subject has received, or is scheduled to receive, another IMP from 1 month before to 1 month after inclusion in this study.
- Current or prior androgen deprivation therapy; previous use of a 5-α reductase inhibitor is allowed, provided it was discontinued at least one month prior to study entry.
- Poorly controlled hypertension, with blood pressure at study entry>160/100.
- Contraindication for or inability to tolerate MRI examination.
- Prostate biopsy within 12 weeks prior to study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pyruvate | Drug | Part 1: Reproducibility, Part 2: Treatment Response |
Primary outcome
Difference in peak lactate/pyruvate ratio
Time frame: Baseline and 2-3 weeks after 1st image
Difference in peak lactate/pyruvate ratio
Time frame: Baseline and 2 months after 1st image
5 secondary outcomes
Pyruvate area under the curve (AUC)
Time frame: Baseline and 2-3 weeks after 1st image
Lactate area under the curve (AUC)
Time frame: Baseline and 2-3 weeks after 1st image
Pyruvate area under the curve (AUC)
Time frame: Baseline and 2 months after 1st image
Lactate area under the curve (AUC)
Time frame: Baseline and 2 months after 1st image
Safety As measured by Adverse Events
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahul Aggarwal, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pyruvate in people with Prostate Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in peak lactate/pyruvate ratio (time frame: Baseline and 2-3 weeks after 1st image). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018; AzTrials last refreshed its copy on 30 Oct 2026.