Special MRI for Prostate Cancer
Recruiting in Palo Alto (17 mi)
Overseen byIvan de Kouchkovsky, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Ivan de Kouchkovsky, MD
Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers
Disqualifiers: Hypertension, Heart failure, EKG abnormalities, others
Stay on Your Current Meds
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study will evaluate the use of hyperpolarized 13C MRI (HP 13C MRI) and the HP-derived 13C pyruvate-to-lactate conversion rate constant (kPL) as an early response biomarker in men with treatment-naïve, high-risk, localized or locally advanced prostate cancer receiving neoadjuvant therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you must stop using 5-alpha reductase inhibitors at least 3 weeks before starting the trial. You also cannot use strong CYP3A4 inhibitors or inducers during the trial.
What data supports the effectiveness of the drug Abiraterone acetate (Zytiga) in combination with prednisone for prostate cancer?
Research shows that Abiraterone acetate (Zytiga) combined with prednisone significantly improves survival and delays disease progression in patients with metastatic castration-resistant prostate cancer, as demonstrated in clinical trials where it outperformed placebo.
12345Is abiraterone acetate safe for humans?
Abiraterone acetate, used with prednisone, is generally considered safe for treating metastatic castration-resistant prostate cancer, though it can cause side effects like low potassium levels, high blood pressure, fluid retention, and liver issues. These side effects were relatively low in frequency during clinical trials.
12367How is the drug Abiraterone acetate with Prednisone unique for prostate cancer treatment?
Abiraterone acetate with Prednisone is unique because it works by blocking the production of androgens (male hormones) that can fuel prostate cancer growth, offering a different approach compared to traditional chemotherapy. This combination is often used when the cancer has spread and other treatments are no longer effective.
89101112Eligibility Criteria
Men with high-risk, localized or locally advanced prostate cancer who haven't had treatment yet can join this trial. They'll be tested using a special type of MRI to see how well their cancer responds to a new therapy before having surgery.Inclusion Criteria
I am 18 years old or older.
Participant must agree to use a condom and another effective method of birth control if having sex with a woman of childbearing potential or must agree to use a condom if having sex with a pregnant woman while on study drug and for 8 weeks following the last dose of study drug
I have another cancer type, but it won't affect this trial's treatment.
+10 more
Exclusion Criteria
Patients unwilling or unable to undergo MR imaging, including patients with contraindications to MRI such as cardiac pacemakers or non-compatible intracranial vascular clips
Patients who cannot tolerate or have contra-indications to endorectal coil insertion
I have previously undergone treatment for prostate cancer.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Neoadjuvant Treatment
Participants receive neoadjuvant abiraterone/prednisone for 12 weeks, with MRI scans at screening, cycle 2 day 1, and after completion of therapy
12 weeks
3 visits (in-person)
Radical Prostatectomy
Participants undergo planned, non-investigational radical prostatectomy within 7-56 days after last dose of neoadjuvant therapy
1-2 weeks
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up every 3 months for the first year, then every 6 months
Up to 5 years
Regular visits (in-person)
Participant Groups
The study is testing if a special MRI scan called HP 13C MRI can show early on if the cancer treatment is working. Men in the trial will take Abiraterone and Prednisone before getting their prostates removed surgically.
1Treatment groups
Experimental Treatment
Group I: Treatment (Abiraterone/Prednisone, Hyperpolarized (HP) 13C Pyruvate)Experimental Treatment6 Interventions
Neoadjuvant abiraterone (1000mg) will be administered for three 28-day cycles, in conjunction with 5mg of prednisone. Participants will undergo a paired multi-parametric/hyperpolarized MRI of the prostate at screening, cycle 2 day 1, and after completion of neoadjuvant therapy. With each scan, a hyperpolarized 13C-pyruvate injection will be administered. A planned, non-investigational RP will be completed within 7-56 days after last dose/discontinuation of neoadjuvant study drug. Participants will be followed up until death, withdrawal of consent, or end of study, whichever occurs first.
Abiraterone acetate is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Zytiga for:
- Metastatic castration-resistant prostate cancer
🇺🇸 Approved in United States as Zytiga for:
- Metastatic castration-resistant prostate cancer
- High-risk metastatic hormone-sensitive prostate cancer
🇨🇦 Approved in Canada as Zytiga for:
- Metastatic castration-resistant prostate cancer
🇯🇵 Approved in Japan as Zytiga for:
- Metastatic castration-resistant prostate cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, San FranciscoSan Francisco, CA
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Who Is Running the Clinical Trial?
Ivan de Kouchkovsky, MDLead Sponsor
References
Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer: U.S. Food and Drug Administration drug approval summary. [2018]On December 10, 2012, the U.S. Food and Drug Administration granted full approval for a modified indication for abiraterone acetate (Zytiga tablets; Janssen Biotech, Inc.) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). The approval was based on clinical trial COU-AA-302, which randomly allocated asymptomatic or mildly symptomatic patients with chemotherapy-naïve mCRPC and no visceral metastases to either abiraterone acetate plus prednisone (N = 546) or placebo plus prednisone (N = 542). The coprimary endpoints were radiographic progression-free survival (rPFS) and overall survival (OS). The median rPFS was 8.3 months in the placebo arm and had not yet been reached in the abiraterone acetate arm {HR, 0.43 [95% confidence interval (CI) 0.35-0.52]; P
Value of treatment in clinical trials versus the real world: the case of abiraterone acetate (Zytiga) for postchemotherapy metastatic castration-resistant prostate cancer patients in Sweden. [2017]In a randomized clinical trial (COU-AA-301), abiraterone acetate (Zytiga(®)) was shown to be superior to prednisone in the treatment of metastatic castration-resistant prostate cancer (mCRPC). However, the value of abiraterone treatment for patients with mCRPC in clinical practice in Sweden is not known. The aim of this study was to compare the outcomes and treatment patterns of abiraterone treatment in a Swedish observational study to those of the pivotal clinical trial, thereby discussing the external validity of the postchemotherapy clinical trial from a Swedish perspective.
Abiraterone acetate: a guide to its use in metastatic castration-resistant prostate cancer. [2021]Oral abiraterone acetate (Zytiga®), a selective cytochrome P450 17A1 enzyme inhibitor, is used in combination with prednisone or prednisolone to treat patients with metastatic castration-resistant prostate cancer (CRPC) who have previously received docetaxel-containing chemotherapy. In a clinical trial in patients with CRPC, abiraterone acetate plus prednisone significantly prolonged overall survival, the time to prostate-specific antigen progression and progression-free survival compared with placebo plus prednisone.
The IMAAGEN Study: Effect of Abiraterone Acetate and Prednisone on Prostate Specific Antigen and Radiographic Disease Progression in Patients with Nonmetastatic Castration Resistant Prostate Cancer. [2021]We evaluated the use of abiraterone acetate (1,000 mg) plus prednisone (5 mg) in patients with high risk, nonmetastatic, castration resistant prostate cancer.
Switch from abiraterone plus prednisone to abiraterone plus dexamethasone at asymptomatic PSA progression in patients with metastatic castration-resistant prostate cancer. [2019]To evaluate the effects of switching from prednisone (P) to dexamethasone (D) at asymptomatic prostate-specific antigen (PSA) progression in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone acetate (AA).
Abiraterone acetate: a review of its use in patients with metastatic castration-resistant prostate cancer. [2021]Abiraterone acetate (Zytiga(®)) is an orally administered, selective inhibitor of the 17α-hydroxylase and C17,20-lyase enzymatic activities of cytochrome P450 (CYP) 17. CYP17 is required for androgen biosynthesis, with androgen receptor signalling crucial in the progression from primary to metastatic prostate cancer. Abiraterone acetate is approved in the European Union and the US, in combination with prednisone or prednisolone, for the treatment of men with metastatic castration-resistant prostate cancer (CRPC). When administered in combination with prednisone in a placebo-controlled, multinational phase III study, abiraterone acetate significantly prolonged overall survival and radiographic progression-free survival (rPFS) in men with metastatic CRPC who had previously received docetaxel. In men with metastatic CRPC who had not previously received chemotherapy participating in a placebo-controlled, multinational phase III study, there was a strong trend towards an overall survival benefit, a significant prolongation in rPFS and significant delays in clinical decline, the need for chemotherapy and the onset of pain observed. Given the nature of the therapy, the overall tolerability profile of abiraterone acetate, in combination with prednisone, was acceptable in men with metastatic CRPC. Abiraterone acetate is associated with hypokalaemia, hypertension, and fluid retention or oedema, secondary to its mechanism of action, and with cardiac adverse events and hepatotoxicity; however, in the phase III studies the incidences of the most frequently reported grade 3 or 4 adverse events of special interest were relatively low. Although the final overall survival data in men with metastatic CRPC who have not previously received chemotherapy are awaited, current evidence indicates that abiraterone acetate is a useful option for the treatment of metastatic CRPC.
Pharmacokinetics and bioequivalence of generic and branded abiraterone acetate tablet: a single-dose, open-label, and replicate designed study in healthy Chinese male volunteers. [2022]Abiraterone acetate is a highly variable drug and has been approved for the treatment of patients with metastatic castration-resistant prostate cancer in many countries. This study was conducted to compare the pharmacokinetic profile between the test product (abiraterone acetate tablet) and reference product ZYTIGA® (250 mg) mainly.
Interscanner comparison of dynamic contrast-enhanced MRI in prostate cancer: 1.5 versus 3 T MRI. [2013]The aim of the study was the comparison of the diagnostic potential of dynamic contrast-enhanced magnetic resonance imaging to differentiate between prostate carcinoma and normal prostate tissue as well as prostatitis at 2 different field strengths: 1.5 versus 3 T.
PI-RADS 2.1 - Image Interpretation: The Most Important Updates and Their Clinical Implications. [2022]Multiparametric magnetic resonance imaging (MRI) of the prostate plays a central role in the diagnosis of patients with suspected prostate cancer. The increasing distribution and application of the guideline for the standardization of image acquisition, evaluation, and reporting (Prostate Imaging - Reporting and Data System, PI-RADS), which was updated in 2019 to version 2.1, contributes to the success of the technique.
MR imaging of the prostate in clinical practice. [2022]Magnetic resonance imaging (MRI) is the imaging tool of choice in the evaluation of prostate cancer. The main applications of MR imaging in the management of prostate cancer are: (1) to guide targeted biopsy when prostate cancer is clinically suspected and previous ultrasound-guided biopsy results are negative; (2) to localize and stage prostate cancer and provide a roadmap for treatment planning; and (3) to detect residual or locally recurrent cancer after treatment. Other MR techniques such as proton MR spectroscopic imaging (MRSI), diffusion-weighted imaging (DWI), and contrast-enhanced MRI (CE-MRI) complement conventional MR imaging by providing metabolic and functional information that can improve the accuracy of prostate cancer detection and characterization. In everyday clinical practice, and to account for patient comfort, MR imaging studies are limited to 1 h. To obtain consistently high-quality images, a well-designed protocol is necessary. Routine MR imaging can be supplemented by other MR techniques such as MRSI, DWI or CE-MRI depending on the expertise available and the clinical questions that need to be answered. This review summarizes the role of MR imaging in the management of prostate cancer and describes practical approaches to implementing anatomic, metabolic and functional MR imaging techniques in the clinic.
Magnetic resonance imaging for prostate cancer: what the urologist needs to know. [2017]The use of magnetic resonance imaging (MRI) for prostate cancer imaging has been an area of burgeoning research activity with a goal of finding imaging characteristics that will allow for improved diagnosis and surveillance of prostate cancer. This article will review the MRI sequences currently used for imaging the prostate and describe the scoring and reporting system used by radiologists for prostate MRI known as the Prostate Imaging Reporting and Data System (PI-RADS). Current research regarding the role of prostate MRI for patients without prior biopsy, with prior negative biopsy and elevated PSA, and on active surveillance protocols will also be reviewed.
The value of magnetic resonance imaging in the detection of prostate cancer in patients with previous negative biopsies and elevated prostate-specific antigen levels: a meta-analysis. [2022]To assess the diagnostic performance of magnetic resonance imaging (MRI) for targeting prostate cancer in patients with previous negative biopsies and elevated prostate-specific antigen (PSA) levels.