PET-CT Imaging for Prostate Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: City of Hope Medical Center
Disqualifiers: Psychiatric disorder, Substance abuse, Weight, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This clinical trial evaluates \[18F\]-rh PSMA positron emission tomography (PET)-computed tomography (CT) imaging performance in patients with prostate cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 18F-rhPSMA. Because some cancers take up \[18F\]-rhPSMA, cancer cells can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Posluma (18F-rhPSMA) is an approved prostate-specific membrane antigen (PSMA) imaging agent for prostate cancer. The RefleXion Medical Radiotherapy System (RMRS) is designed to facilitate delivery of biology-guided radiotherapy (BgRT). The system uses PET emissions to guide radiotherapy delivery in real-time and has been studied for use with fludeoxyglucose (FDG) (which is an agent used in standard PET-CT scans that targets glucose). Information gathered from this study may help researchers to improve PET-CT imaging on the RefleXion system. This information will be used in the future to improve planning and delivery of radiation therapy that will target (in real time) the signal released from the \[18F\]-rhPSMA PET-CT tracer. Comparing the imaging from the standard of care \[18F\]-rh PSMA PET-CT with the imaging from RMRS may help improve the quality of the imaging captured on the RMRS for detection of imaging signals in patients with prostate cancer.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment RefleXion Medical Radiotherapy System (RMRS) for prostate cancer?
PET imaging, which is part of the RefleXion Medical Radiotherapy System, is shown to be important in diagnosing and managing prostate cancer by helping to identify the true extent of the disease, especially in cases where standard imaging falls short. This can lead to more personalized treatment plans and potentially better outcomes for patients.
12345Is PET-CT Imaging for Prostate Cancer safe for humans?
The research articles focus on radiation therapy for prostate cancer, discussing side effects and toxicity, but do not specifically address the safety of PET-CT Imaging or the RefleXion Medical Radiotherapy System (RMRS).
678910How is PET-CT imaging unique in treating prostate cancer?
PET-CT imaging is unique for prostate cancer as it combines positron emission tomography (PET) and computed tomography (CT) to provide detailed images that help in understanding the tumor's biology and spread. This noninvasive method can improve diagnosis, detect metastases, and monitor treatment response, offering a more comprehensive view compared to traditional imaging techniques.
18111213Eligibility Criteria
This trial is for adults over 21 with prostate cancer who have already had a standard PET-CT scan showing active cancer spots. They must be able to undergo an additional RMRS PET scan on the same day and provide informed consent.Inclusion Criteria
I am 21 years old or older.
Able to get same day X1 RMRS PET
My PET scan shows active cancer spots.
+1 more
Exclusion Criteria
Known psychiatric or substance abuse disorder that would interfere with conduct of the study
Patient weight exceeding the weight limit (450 pounds) outlined per X1 RMRS specifications sheet
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Imaging
Participants receive SOC flotufolastat F-18 gallium IV and undergo PET-CT on study, followed by X1 RMRS PET-CT imaging-only session 120 minutes post-injection
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after imaging session
Up to 72 hours
1 visit (in-person or virtual)
Participant Groups
The study tests how well a new type of PET-CT imaging using [18F]-rhPSMA works compared to the current method. It's part of research to improve real-time, targeted radiation therapy planning and delivery in prostate cancer treatment.
1Treatment groups
Experimental Treatment
Group I: Device Feasibility ([18F]-rhPSMA PET-CT, X1 RMRS PET-CT)Experimental Treatment4 Interventions
Patients receive SOC flotufolastat F-18 gallium IV and undergo PET-CT on study. Patients then undergo X1 RMRS PET-CT imaging-only session 120 minutes post-injection.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
City of Hope Medical CenterDuarte, CA
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Who Is Running the Clinical Trial?
City of Hope Medical CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Quantitative Analysis of Serial Positron Emission Tomography Imaging in Men with Metastatic Castration-resistant Prostate Cancer Treated with Enzalutamide. [2023]The emergence of positron emission tomography (PET) in prostate cancer is impacting clinical practice, but little is known about PET imaging as a tool to determine treatment failure in metastatic castration-resistant prostate cancer (mCRPC).
PET and Radiation Therapy Planning and Delivery for Prostate Cancer. [2016]PET imaging has become an integral component of the diagnosis and management of a substantial number of lymphatic and solid malignancies. One of the greatest dilemmas in prostate cancer remains the need for greater personalization of treatment recommendations based on the true extent of disease, so that patients with extraprostatic, micrometastatic disease can be identified early and managed accordingly. These sites currently remain under the level of detection with standard imaging and continue to confound clinicians. Novel PET tracers to complement anatomic data from CT and MR imaging can truly make a difference, and ongoing research holds the greatest promise.
The role of PET/computed tomography scan in the management of prostate cancer. [2015]To evaluate the role of PET/computed tomography (CT) imaging in patients with prostate cancer and to provide clinical recommendations, both in pretreatment and in post-treatment phase.
Predicting post-external beam radiation therapy PSA relapse of prostate cancer using pretreatment MRI. [2021]To investigate whether pretreatment endorectal magnetic resonance imaging (MRI) findings can predict biochemical relapse in patients with clinically localized prostate cancer treated with external beam radiation therapy (EBRT).
18F-Fluciclovine Positron Emission Tomography in Men With Biochemical Recurrence of Prostate Cancer After Radical Prostatectomy and Planning to Undergo Salvage Radiation Therapy: Results from LOCATE. [2021]Label="PURPOSE" NlmCategory="OBJECTIVE">Conventional imaging rarely localizes the site(s) of prostate cancer recurrence in patients undergoing evaluation for salvage radiation therapy (sRT) after radical prostatectomy (RP). LOCATE (NCT02680041) was a prospective, multicenter study investigating the impact of 18F-fluciclovine positron emission tomography and computed tomography (PET/CT) on the management of patients with biochemical recurrence of prostate cancer after curative-intent radiation or RP and negative or equivocal conventional imaging. Our objective was to determine the impact of 18F-fluciclovine PET/CT on treatment decisions for men planning to undergo sRT for biochemical recurrence post-RP.
Comparative toxicity and dosimetric profile of whole-pelvis versus prostate bed-only intensity-modulated radiation therapy after prostatectomy. [2012]To assess whether whole-pelvis (WP) intensity modulated radiation therapy (IMRT) for prostate cancer (PCa) after prostatectomy is associated with increased toxicity compared to prostate-bed only (PB) IMRT.
Comparison of daily cone-beam computed tomography and kilovoltage planar imaging for target localization in prostate cancer patients following radical prostatectomy. [2016]To review our initial clinical experience with image-guided radiation therapy (IGRT) using cone-beam computed tomography (CBCT) for prostate bed localization in post-radical prostatectomy (RP) patients and to compare shift and acute toxicity results to our previously published IGRT experience with daily kV planar imaging.
Comparison of megavoltage position verification for prostate irradiation based on bony anatomy and implanted fiducials. [2019]The patient position during radiotherapy treatment of prostate cancer can be verified with the help of portal images acquired during treatment. In this study we quantify the clinical consequences of the use of image-based verification based on the bony anatomy and the prostate target itself.
A comparison of side-effects and quality-of-life in patients operated on for prostate cancer with and without salvage radiation therapy. [2022]The extent of late side-effects in prostate cancer patients, after radical prostatectomy (RP = reference group) and salvage radiation therapy (SRT) in a self-reporting perspective (PROM) is still under-reported. We aimed to investigate the rate and severity of side-effects and quality-of-life (QoL) according to PROM.
The burden of overtreatment: comparison of toxicity between single and combined modality radiation therapy among low risk prostate cancer patients. [2015]To compare radiation related toxicities among men with low risk prostate cancer treated with single or multimodal radiation therapy.
[Positron emission tomography for molecular imaging of prostate cancer]. [2018]Prostate cancer is the most common malignancy in the urinary system of males. The remarkable biological and clinical heterogeneity of prostate cancer poses challenges to the initial diagnosis, differential diagnosis, treatment, and prognosis of the disease. Positron emission tomography/computed tomography (PET/CT) is an ideal imaging tool for noninvasive interrogation of underlying tumor biology. Recently, there are a variety of molecular imaging paths and radiopharmaceuticals for the diagnosis and treatment of prostate cancer. This article reviews the current state and prospects of the application of PET in the diagnosis of prostate cancer.
Molecular research in urology 2014: update on PET/MR imaging of the prostate. [2021]This article gives an overview of recent publications and potential indications of Positron emission tomography/ Magnetic resonance (PET/MR) imaging of prostate cancer.
[89Zr]A2cDb Immuno-PET of Prostate Cancer in a Human Prostate Stem Cell Antigen Knock-in (hPSCA KI) Syngeneic Model. [2021]A great challenge in the diagnosis and treatment of prostate cancer is distinguishing between indolent or local disease and aggressive or metastatic disease. Antibody-based positron emission tomography (immuno-PET) as a cancer-specific imaging modality could improve diagnosis of primary disease, aid the detection of metastases to regional lymph nodes as well as to distant sites (e.g., bone), and monitor response to therapy.