Doug asked "Does anyone know if a PSMA scan is the best test for Initial detection of prostate cancer?" For more information, click "+" on the trials below. Per-lesion analysis using Pearson Chi-square assessed the impact of a positive PSMA PET/CT on the location of clinical recurrence after PSMA PET/CT. Telix is a collaborator with Emory University. Currently, in the United States and many other countries, most men diagnosed with high-risk localized prostate cancer undergo additional testing to see if there is evidence of metastatic canc… However, the amount of radiation exposure from a PSMA-PET/CT scan was found to be lower than with … A clinical trial conducted by the UCSF and UCLA research teams on the effectiveness of PSMA PET proved pivotal in garnering FDA approval for the technique at both universities. During the scan, they will lie on their back and stay still. However, it is unclear if incorporation of 68Ga-PSMA-11 PET/CT imaging into the planning of salvage radiotherapy could improve its likelihood of success. The clinical trial will outline the inclusion and exclusion criteria. The approaches involve the use of prostate-specific PET scans targeting the androgen receptor or prostate-specific membrane antigen (PSMA) as a target. Twenty-two subjects reported mild adverse events after the scan; all resolved completely. During a PET scan, the tracer binds to prostate cancer cells like a lock fits into a key. Patients who received 18F-labeled PSMA-PET at … NaF PET/CT scan cannot substitute for a bone scan. Brief Summary: This trial studies how well 68Ga-PSMA-11 PET/CT scan works in imaging patients with prostate cancer. Participants can have PSMA targeted imaging with Gallium. Once the PSMA PET scan is completed, men can receive prostate cancer care at UCLA Health’s hospitals in Westwood and Santa Monica, or at UCLA Health’s Encino medical office. Martin G. Pomper, M.D., Ph.D., Director of Nuclear Medicine and Molecular Imaging, and Steven P. Rowe, M.D., Ph.D., have just come up with the solution. Diagnostic imaging procedures, such as 68GA-PSMA-11 PET/CT scan, may help doctors plan the best treatment for prostate cancer. A single-centre, prospective clinical trial at the Princess Alexandra Hospital recruited 30 patients with BCR. A Study of 68GA-PSMA-Gadoxetate PET/MR or PET/CT for Evaluation of Hepatocellular Carcinoma Rochester, MN. “PSMA PET/CT is a novel molecular and functional imaging modality specific for prostate cancer cells that Dear William, MSK does offer C-11 PET scans in this circumstance. In a prospective clinical trial, we aimed to evaluate the diagnostic yield and therapeutic impact of PSMA PET/MRI in men with biochemical recurrence (BCR) following curative therapy. Twenty-two subjects reported mild adverse events after the scan; all resolved completely. This trial was led by Prof Michael Hofman from the Peter MacCallum Cancer Centre. A prospective multicenter trial is currently under way, offering a compelling example of translational medicine. All of the clinical trials involving PSMA will be listed, including some that involve treatment rather than exam. A change in treatment intent occurred in 65.5% of subjects, disease stage changed in 65.5%, and management plans changed in 87.3%. I was hoping to have a Pyle PSMA scan to put my mind at ease. Sloan is $7000 out of pocket. The machine will take pictures of the body. This randomized phase III trial studies the success rate of definitive radiation therapy (dRT) for prostate cancer (PCa) with or without planning based on PSMA PET. The FDA approved the drug for positron emission tomography (PET) imaging of PSMA-positive lesions in men with prostate cancer. Prostate cancer cells often replace healthy prostate tissues, so changes aren’t as visible. This phase II trial investigates how well 68Ga PSMA-11 PET / CT scan works in enhancing the diagnosis of prostate cancer that is primary or has spread to other places in the body (metastatic). Phase II trial to compare the performance of a PET/CT using 18 F-fluciclovine and PET/CT using 68 Ga-PSMA in the planning of radiation therapy and enhancing the outcomes of patients with prostate cancer. December 4, 2020. The cancer cells then “light up.”. The approaches involve the use of prostate-specific PET scans targeting the androgen receptor or prostate-specific membrane antigen (PSMA) as a target. MSK just closed recruitment their PLY study. The PSMA drug used in the technique was developed outside the U.S. by the University of Heidelberg. This phase II trial studies how well 68Ga-PSMA PET/MRI or PET/CT works in early detection of liver cancer. I have had C 11s done at Mayo, the scans are very much alike. I think PSMA is the direction that lots of PCa diagnostics are headed in, but since the shift is still in the pre-FDA approval phase, you'll need to play the clinical-trial chess game to … Retrospective clinical data suggest PET/CT imaging using 68 Ga-labelled PSMA-11 will radically transform diagnostics, staging and operation planning of prostate cancer. FDA approved the first PSMA-targeted PET imaging drug, Ga 68 PSMA-11, on December 1, 2020, for the same prostate cancer imaging indications as Pylarify. What you need to know about the newly approved 68 Ga-PSMA-11 PET agent for prostate cancer. After completion of dRT, clinical follow-up of patients with their treating radiation oncologist will be obtained for 5 years. Patients then undergo dRT at the discretion of the treating radiation oncologist, who receives the PSMA PET result and images. PSMA-targeted radiopharmaceutical clinical trials in the US. This new “PSMA PET” scan can detect prostate cancer metastases much earlier, when they are much smaller, which may help to improve treatment of patients with prostate cancer. metastasis directed therapy for oligometastatic disease, the OSPREY prostate cancer trial, PSMA PET is likely anywhere from 10 to a 100 times better than conventional imaging, stereotactic ablative radiation for oligometastatic prostate cancer, the ORIOLE trial, 18F DCFPyl PET, stereotactic body radiotherapy, 18F DCFPyl PET now has an FDA PDUFA date, new advances and approvals for PSMA-PET … Brief Summary: This phase II trial studies the impact of 68GA-PSMA-11 positron emission tomography (PET)/computed tomography (CT) scan on treatment strategies for patients with prostate cancer. FDA. A prospective multicenter trial is currently under way, offering a compelling example of translational medicine. 68Ga-PSMA-11 is a radioactive imaging agent that binds to prostate cancer cells to help localize prostate cancer cells. Additionally, patients had to have a [68Ga]Ga-PSMA-11 PET/CT scan, clinical data, and information on survival outcomes available. Now that the VISION trial of Lu-177-PSMA-617 is no longer recruiting, some patients are wondering if they can still get PSMA-targeted radiopharmaceuticals in the US, without traveling to Germany, Australia, India, etc. A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA 7.3 (18F) Positron Emission Tomography (PET) ligand in men with suspected prostate cancer recurrence based on elevated Prostate-specific antigen (PSA) following prior … Clinical trials look at new ways to prevent, detect, or treat disease. PET takes pictures of the inside the body using a special substance or “tracer” that is injected through a needle in the arm. This phase II trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in detecting the spread of cancer to the bones (bone metastasis) in patients with prostate cancer and increased PSA after treatment (biochemical recurrence) during androgen deprivation therapy. Purpose: Primary staging of prostate cancer relies on modalities, which are limited. Breast Imaging with Positron Emission Mammography Rochester, MN. PET/CT is used to describe information regarding the function, as well as location and size of a tumor. Conclusion: 18 F-DCFPyL PET/CT is safe and sensitive for the localization of biochemical recurrence of prostate cancer. A change in treatment intent occurred in 65.5% of subjects, disease stage changed in 65.5%, and management plans changed in 87.3%. Conclusion: 18 F-DCFPyL PET/CT is safe and sensitive for the localization of biochemical recurrence of prostate cancer. Most patients with localized PC will be cured with surgery or radiation therapy, but up to 35% of patients will have their PC return. A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA 7.3 (18F) Positron Emission Tomography (PET) ligand in men with suspected prostate cancer recurrence based on elevated Prostate-specific antigen (PSA) following prior … 21,22,24-28 We demonstrate in this prospective multicenter trial that 68 Ga-PSMA-11 PET positivity identifies with very high likelihood of prostate cancer. December 01, 2020. They will have a PET/CT scan of their whole body 60 90 minutes later. However, it is unclear if incorporation of 68Ga-PSMA-11 PET/CT imaging into the planning of salvage radiotherapy could improve its likelihood of success. If successful, 68Ga-PSMA PET would provide an alternative and potentially more specific means to monitor tumor blood vessels in patients. Prior PSMA PET scan within 6 months of enrollment. Doctors can use the method to localize metastases and determine how well treatments are targeting disease sites. About Clinical ... this research study is to see if recurrent prostate cancer can be identified using a special procedure called a positron emission tomography (PET) scan. Doug asked "Does anyone know if a PSMA scan is the best test for Initial detection of prostate cancer?" Whether it has returned locally or distantly determines which type of treatment they will receive. View trial on ClinicalTrials.gov We explored the diagnostic utility of PSMA PET-CT as a replacement for conventional imaging. PSMA-PET Data System You know you’re doing something right when you have to develop a widespread system to support your work. These images are laid over MRI scans or ultrasound images of the affected areas of your body. The criteria of the Prostate Cancer Clinical Trials Working Group (PCWG2) include clinical and laboratory parameters, as well as conventional imaging modalities such as MRI, CT, and bone scan findings, but advanced molecular imaging techniques, especially prostate-specific membrane antigen (PSMA) PET findings, are not considered. It is also proposed to have a longer shelf life- which would allow more PET scan facilities to offer it than can be currently offered using GA-PSMA. NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Patients who received 18F-labeled PSMA-PET at … These patients were scanned using Ga68-PSMA for either staging or response evaluation. This scan is investigational and has not yet been approved by the U.S. Food and Drug Administration. 68Ga-PSMA-11 PET/CT is an experimental scan that can sometimes detect recurrent regional and distant metastatic prostate cancer at lower PSA levels than standard of care imaging. The new PSMA PET for prostate cancer diagnosis. Unable to refrain from fathering a child or donating sperm for 10 days after each 18FDCFPyL injection. 68Ga PSMA-11 is a radioactive drug that carries a small amount of radiation that can be detected by the PET / CT scan. Doctors can use the method to localize metastases and determine how well treatments are targeting disease sites. Retrospective clinical data suggest PET/CT imaging using 68 Ga-labelled PSMA-11 will radically transform diagnostics, staging and operation planning of prostate cancer. Implication for Nursing Practice. The F 18 tracer went through two qualifying clinical trials the CONDOR trial and then OSPREY trial. The safety and efficacy of Ga 68 PSMA-11 were evaluated in two prospective clinical trials with a total of 960 men with prostate cancer who each received one injection of Ga 68 PSMA-11. CLINICAL TRIALS. The study aimed to summarize clinical characteristics associated with Gallium-68-prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (68 Ga-PSMA PET/CT) scans as patients were restaged for prostate-specific antigen (PSA) relapse after radical prostatectomy (RP) or external beam radiotherapy (EBRT).Our analyses included multiple cox … Trial Reference: NCT03762759. This phase II trial studies how well 68Ga-PSMA PET/MRI or PET/CT works in early detection of liver cancer. It would now need to go through administration of the scan and … Within 60 days after the scan, participants will have surgery. Columbia trial is closed. All trials on the list are supported by NCI. Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT may find and diagnose prostate cancer and improve monitoring of treatment response. Routinely collected clinical data help identify men with high-risk prostate cancer most likely to benefit from a gallium-68 prostate-specific membrane antigen (PSMA) PET/CT scan, according to a study reported at the American Society for Radiation Oncology Annual Meeting 2020. The purpose of this study is to examine PSMA and C-11 Choline PET in patients with suspected metastatic prostate cancer who have been imaged with 11C-Choline PET clinically and with PSMA PET (either Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) or F-18 PSMA 1007) in order to demonstrate their utility in detecting prostate cancer. Telix is a collaborator with Emory University. In line with our findings, 68 Ga-PSMA-11 PET PPV for localization of prostate cancer was consistently 0.80 or more. ARM II: Patients undergo PSMA PET for dRT planning. I think PSMA is the direction that lots of PCa diagnostics are headed in, but since the shift is still in the pre-FDA approval phase, you'll need to play the clinical-trial chess game to … ProPSMA, an Australian clinical trial for PSMA-PET scans at diagnosis. PSMA: A Windfall for PET/CT Imaging. As Virginianorthern says, UCLA and UCSF PSMA exams are FDA approved. You are exposed to radiation through the PET scan, or the PET/CT scan if a CT scan is also used. Given the increased utilisation of PSMA PET/CT scan as a primary staging investigation in clinical practice for prostate cancer and as an alternative to bone scan and CT scan, it is timely for prostate cancer specialist nurses to understand and recognise the specificity and sensitivity of PSMA PET/CT scans in prostate cancer staging. SNMMI 2021: PSMA PET Drug Development: Clinical Trial Design and Statistical Considerations (UroToday.com) The Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2021 Annual Meeting included a session on FDA Radiopharmaceutical updates and a presentation by Drs. The FDA has approved piflufolastat F 18 (Pylarify) injection, a prostate-specific membrane antigen (PSMA)–targeted positron emission tomography (PET) imaging agent, to … 2. The scan can also be used in conjunction with care at any other hospital where the patient is being treated. Methods: In this study, we evaluated PET scans of 262 patients with diagnosis of prostate cancer. All patients received one injection of Ga 68 PSMA-11 and underwent PET/CT or PET/MRI scans. Results from an Australian clinical trial testing the value of PSMA-PET scans were published last week in a top journal called The Lancet. PSMA: A Windfall for PET/CT Imaging. Whether it has returned locally or distantly determines which type of treatment they will receive. - Bone scan Participants will have a radiotracer injected into a vein. The total time it takes for a PSMA PET scan is about two hours. The clinical trials on this list are studying Gallium Ga 68-labeled PSMA-11. Before the scan, you have a small amount of a radioactive tracer (dye) as an injection into your bloodstream. 68Ga-PSMA-11 PET/CT is an experimental scan that can sometimes detect recurrent regional and distant metastatic prostate cancer at lower PSA levels than standard of care imaging. If you make an appointment with one our prostate cancer medical oncologists for a consultation, and if it appears that a C-11 choline scan is appropriate, then they will order it, review the result with you, and offer appropriate treatment options based on the result. This phase II trial studies the use of 68Ga-PSMA-11 positron emission tomography (PET) in diagnosing patients with prostate cancer that continues to grow despite the surgical removal of the testes or medical intervention to block androgen production … PSMA-targeted imaging within 6 months with 18F-DCFPyL tracer prior to the date of 18F-DCFPyL PET/CT imaging. For this procedure, a cell-targeting molecule linked to a radioactive substance is injected into the body and travels through the blood. Enter prostate cancer as the disease and PSMA as the key word. PSMA-targeting PET has been suggested to be a superior method for imaging in prostate cancer compared with standard imaging modalities although it is not yet approved for use in the United States. PSMA- PET-based dRT, may improve radiation therapy planning and patient selection for dRT, and potentially improve its outcome compared to dRT without PSMA PET (standard dRT). Phase II trial to compare the performance of a PET/CT using 18 F-fluciclovine and PET/CT using 68 Ga-PSMA in the planning of radiation therapy and enhancing the outcomes of patients with prostate cancer. What this means for patients: Today, a new type of prostate cancer scan known as 68Ga-PSMA-11 PET was approved by the FDA. The approval followed two clinical trials encompassing a total of 960 patients. Given lack of specificity of CT for lymph node metastases at lower thresholds, pelvic lymph nodes below 2 cm in the short axis are allowed. A total of 302 men were randomly assigned to receive either CT and bone scan (conventional imaging) or PSMA PET/CT. They are called choline and prostate specific membrane antigen (PSMA). If you consent to participating in this study, you will undergo 1 or 2 PET imaging scans, in addition to your routine standard-of-care imaging studies. Prostate cancer (PC) is the third most common cause of cancer death in men. The EAU/ESUR/ESTRO/SIOG 2020 guidelines relating to PSMA PET scan suggest that men with a persistent PSA > 0.2 ng/mL after radical prostatectomy should be offered a PSMA PET/CT to exclude metastatic disease (weak recommendation). 18F-DCFPyL is an investigational PSMA-targeted PET tracer. On December 1st, 2020, the FDA approved the 68Ga-PSMA-11 PET Scan for the diagnosis of prostate cancer. This phase II trial studies how well 18F-DCFPyL PET / CT scan works in detecting a protein called PSMA in patients with HER2-negative, androgen receptor positive breast cancer. PSMA PET scan Pronunciation: (… skan) An imaging procedure that is used to help find prostate cancer cells in the body. This is great news for all urologists and their patients, considering the effectiveness of this new diagnosis method. Most men diagnosed with prostate cancer have localized disease, meaning the cancer appears to be confined to the prostate gland. Given the increased utilisation of PSMA PET/CT scan as a primary staging investigation in clinical practice for prostate cancer and as an alternative to bone scan and CT scan, it is timely for prostate cancer specialist nurses to understand and recognise the specificity and sensitivity of PSMA PET/CT scans in prostate cancer staging. The primary purpose of this trial is to demonstrate the feasibility of integrated 68Ga-PSMA-gadoxetate PET/MRI ot PET/CT for imaging patients with Hepatocellular Carcinoma (HCC), and to compare the accuracy of 68Ga-PSMA-gadoxetate PET/MRI with MRI for staging of HCC. The purpose of this study is to see if a new diagnostic research agent named 68Ga-HBED-CC-PSMA can show prostate cancer on a PET/CT scan that cannot be seen on other standard imaging even when the PSA levels are very low. This phase II trial studies how well a positron emission tomography (PET) / computed tomography (CT) scan using fluciclovine F18 compared with a PET / CT scan with gallium Ga 68-labeled PSMA-11 works in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma. The purpose of this study is to determine if Prostate-Specific Membrane Antigen (PSMA) positron emission tomography (PET) scans used in this study accurate and better at imaging participants' prostate cancer than the usual methods. Results: 336 PSMA scans were performed. This prospective multicentre trial of 300 men was led by Professor Michael Hofman from Peter Mac, with Professor Declan Murphy as senior author. PSMA PET … In March 2020, the results of the proPSMA trial were published in the Lancet. Description This phase II / III trial studies how well serial PSMA PET scans work in imaging patients with prostate cancer that is newly diagnosed, growing, spreading, or getting worse (progressive), or has spread to other places in the body (metastatic). Trial Reference: NCT03762759. These trials are approved by the UBC BC Cancer Research Ethics Board and Health Canada. PSMA PET scan Pronunciation: (… skan) An imaging procedure that is used to help find prostate cancer cells in the body. The proPSMA trial aimed to investigate whether PSMA PET-CT had improved accuracy when compared with the combination of CT and bone scan. It is only FDA approve for trials. Other trials, including a smaller trial of 177 Lu-PSMA-617 conducted in Australia, have also used PSMA PET imaging, but had somewhat more stringent criteria for PSMA-positive disease. Michael Morris, MD joins Charles Ryan, MD in a discussion on the United States (US) FDA Approval of PYLARIFY®, an F 18-labeled prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent. This phase II trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in detecting the spread of cancer to the bones (bone metastasis) in patients with prostate cancer and increased PSA after treatment (biochemical recurrence) during androgen deprivation therapy. Marketed Ga 68 PSMA-11 is … This study aims to institute a province-wide registry leveraging the availability of a new Positron Emission Tomography tracer, [18F]-DCFPyL and PET expertise across Ontario centers to improve our ability to characterize patterns of recurrence and personalize therapies in men with recurrent prostate cancer after primary treatment.. Clinical Trials Registry. PET/CT Clinical Trials In addition to performing routine clinical PET/CT scans, the Functional Imaging program in Vancouver also conducts clinical trials investigating new PET radiotracers. Visit clinicaltrials.gov for availability. However, certain factors have been linked to a higher risk of the cancer eventually spreading (or having already spread). In line with our findings, 68 Ga-PSMA-11 PET PPV for localization of prostate cancer was consistently 0.80 or more. I could fly to Los Angeles and gave it done for $2800, but I'm concerned about flying during the pandemic. Additionally, patients had to have a [68Ga]Ga-PSMA-11 PET/CT scan, clinical data, and information on survival outcomes available. PSMA PyL dRT – Prostate Cancer. Participation held virtually no risk and might benefit him. Preparing for your PET-CT scan. Prostate cancer (PC) is the third most common cause of cancer death in men. This is a phase II clinical trial study to show how well the 68Ga-PSMA-11 (ProstaMedix) PET-CT scan works in detecting tumor location and size in patients with suspected or confirmed prostate cancer, as well as prostate cancer that may have come back in patients with elevated PSA ( a prostate-specific antigen tumor marker) after initial treatment. I had the scan done 4/5/2019 I was part of the clinical trial they are doing. If you can get in the study medicare will cover it. The phase III international VISION trial found that treatment with a novel form of prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, in combination with standard-of-care treatment, led to an increase in radiographic progression-free survival (rPFS) and overall survival (OS). Patient cannot lie still for at least 60 minutes or comply with imaging. Under the criteria used in VISION, approximately 87% of men who were screened to possibly participate in the trial were considered to have PSMA-positive disease. ... (MDP) or F-18 PET bone scan. * The ProPSMA study was a prospective, multicenter, randomized, controlled trial of men with high-risk apparently localized prostate cancer. 68Gallium-PSMA is a radioactive tracer designed to circulate through the body and attach itself to the prostate- specific membrane antigen (PSMA) protein on liver cancer cells. It was recently FDA approved after years of clinical research. Prostate-specific membrane antigen (PSMA) imaging is a nuclear medicine exam using positron emission tomography (PET) to detect prostate cancer. Though FDA approval is pending, many men are accessing this technology through ongoing clinical trials. 68Gallium-PSMA is a radioactive tracer designed to circulate through the body and attach itself to the prostate- specific membrane antigen (PSMA) protein on liver cancer cells. I live in CT and can cover the tristate area. Implication for Nursing Practice. 21,22,24-28 We demonstrate in this prospective multicenter trial that 68 Ga-PSMA-11 PET positivity identifies with very high likelihood of prostate cancer. We evaluate simultaneous [68Ga]Ga-PSMA-11 PET (PSMA-PET)/MRI as a new diagnostic method for primary tumor–node–metastasis staging compared with histology and its impact on therapeutic decisions. It is in this area that PSMA PET/CT imaging can be used, in a clinical trial setting, to identify disease burden beyond radionuclide bone scan and CT to redefine high-volume disease. 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