vision trial prostate
VISION Trial: Radionuclide Therapy Reduces Death and Disease Progression in Prostate Cancer Patients June 4, 2021 The targeted radionuclide therapy 177 Lu-PSMA-617 has been proven effective in improving survival in men with advanced prostate cancer, according to recently published results from the VISION trial. A type of cancer therapy that delivers radiation directly to cancer cells may represent the newest advance in the treatment of prostate cancer, according to results from a large clinical trial. A drug called 177Lu-PSMA-617 may be a new option for treating advanced prostate cancer. 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). March 23, 2021. Key Points: The addition of 177 Lu-PSMA-617 to standard-of-care therapy improved both OS and rPFS for men with metastatic castration-resistant prostate cancer ineligible for chemotherapy, meeting both primary endpoints of the phase III VISION trial. The investigational agent is a precision cancer therapy that combines a targeting compound, or ligand, with a therapeutic radioisotope that binds with prostate cancer cells that express PSMA. Patients with metastatic castration-resistant prostate cancer have a less than 1 in 6 chance of surviving 5 years and need new treatment options. VISION study graphic presentation (adopted from J Nucl Med 2019; 60:15041506) The patients will be monitored for survival, disease progression, adverse events, blood tests for hematology, chemistry, PSA levels and change in quality of life. VISION: An international, prospective, open-label, multicenter, randomized phase 3 study of 177 Lu-PSMA-617 in the treatment of patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). In a recent interview with Pharmacy Times, medical oncologist Michael Morris, MD, discussed the newest findings of the phase 3 VISION trial, which is investigating the use of 177Lu-PSMA-617 in patients with advanced prostate cancer.These new findings will be presented at the American Society of Clinical Oncology 2021 annual meeting. ASCO 2022 showcased many important studies in prostate cancer. doi: 10.2967/jnumed.121.263638. Ive had two infusions now. The EAU 2021 Annual Meeting included a presentation by Johann De Bono discussing the VISION trial, a phase 3 study of 177 Lu-PSMA-617 in patients with mCRPC. Axel Merseburger, ASCO 2022: Highlights in prostate cancer clinical trials Phase 3 SHR3680 trial, ENZAMET trial, MAGNITUDE trial, PROPEL trial, phase 2 lutetium 177 trial, VISION trial Published Online: July 7th 2022. Vision trial completion; Denied for Vision Trial; VISION trial confusion. Healthy prostate cells don't contain PSMA, or do at very low levels. Question for those on VISION trial. Dr. Michael J. Morris. Jason M. Broderick. VISION was a phase 3 trial of targeted radioligand therapy in patients with prostate cancer. In the trial, the addition of 177 Lu-PSMA-617 to standard treatment slowed progression of prostate cancer. The VISION trial was a phase III study evaluating LuPSMA plus standard of care compared to standard of care alone in patients with metastatic castration-resistant prostate cancer who had progressed on other lines of treatment. The VISION trial looked at a new type of cancer treatment, called 177Lu-PSMA-617 (also known as Lutetium-177 or lutetium therapy). This was in a group of patients who were heavily pretreated with prior taxane, 1 or 2 novel hormonal agents [NHAs], and then were randomized to Lu-PSMA-617 vs best standard of care, but a taxane, cabazitaxel, was Prostate Specific Antigen (PSA) blood analysis: rising and above 2.0 ng/mL VISION Clinical Trial Results A randomized phase III trial of 177Lu-PSMA-617 + Standard of Care (SOC) versus SOC alone 177Lu-PSMA-617 Prostate cancer cell -radiation ~ 0.7mm 831 PARTICIPANTS 84 sites (56 in North America 28 in Europe) RANDOMIZED 2:1 280 patients received The study will include a total of 400 patients with metastatic prostate cancer and documented positive PSMA PET The international phase III clinical trial, which was co-led by Tulane University medical oncologist Dr. Oliver VISION is an open-label, randomized trial assessing the addition of radiolabeled prostate-specific membrane antigen to standard therapy for PSMA-positive, previously treated metastatic castration-resistant prostate cancer (mCRPC). VISION: An international, prospective, open-label, multicenter, randomized phase III study of 177Lu-PSMA-617 in the treatment of patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). J Nucl Med. This is the VISION trial, utilizing lutetium and PSMA for patients who were PSMA positive, and 87% of the patients at baseline had a positive PSMA scan. 177 Lu-PSMA-617 is a kind of precision cancer therapy merging a targeting compound (ligand) with a Both primary end points of overall and radiographic progression-free survival (rPFS) were met in the phase 3 VISION trial (NCT03511664), which compared the targeted radioligand therapy 177 Lu-PSMA-617 with best supportive care alone in patients with progressive prostate-specific membrane antigen (PSMA)positive metastatic castration-resistant prostate Additional VISION data Median OS (95% CI) for the 177 Lu-PSMA-617 plus best standard of care arm in the VISION study was 15.3 months (14.2, 16.9), [177Lu]-PSMA-617 radionuclide treatment in patients with metastatic castration-resistant prostate cancer (LuPSMA trial): a single-centre, single-arm, phase 2 study. A statistically significant improvement in overall survival (OS) was reported from the phase 3 VISION trial (NCT03511664) with the addition of the targeted radioligand therapy The trial also contains an alternate primary endpoint of radiographic progression-free survival whose integrity requires that patients assigned to the control arm The VISION trial is the first international, randomized study testing the hypothesis that overall survival is increased after treatment with 177 Lu-PSMA-617 in men with advanced-stage prostate cancer. An Overview of the Phase III VISION Trial and Its Importance for the Future of Theranostics Prostate-specific membrane antigen (PSMA) is of considerable interest as a target for diagnostics and therapy of prostate cancer patients. Some basic information for patients is The trial met both primary endpoints of overall survival and radiographic progression-free survival 1, helping to move closer the ambition of becoming the targeted treatment for >80% of patients with advanced prostate cancer. The safety profile was consistent with data reported in previous clinical studies 1. Prostate-specific membrane antigen (PSMA) is 'Substandard' Control Arms in Clinical Trials Practice found common in prostate cancer studies Adding the targeted radioligand therapy 177 Lu-PSMA-617 (LuPSMA) to best standard of care (BSC) improved overall survival (OS) in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), according to findings from the phase 3 VISION trial. In todays podcast, members of the Cancer.Net Editorial Board discuss 3 clinical trials that are exploring new treatment options across prostate, bladder, and kidney cancer. Despite recent therapeutic advances, mCRPC remains invariably fatal. A. Oliver Sartor , Michael J. Morris , Richard Messman , Bernd J. Krause Show More Abstract Disclosures Abstract TPS259 to the editor: in the vision trial reported by sartor et al. The recommendation from the Prostate Cancer Trials Working Group 3 (PCWG 3) while the VISION trial requires 68 Ga-PSMA-11 uptake above normal liver activity [14, 15]. To qualify for enrollment in the study, called the VISION trial, men had to be PSMA-positive. Before any new cancer treatment can be approved for general use, it must be studied in a clinical trial in order to prove it is safe and effective. Doctors can detect the protein using a specialized imaging scan. The study will enroll 750 men in total, with the primary endpoint being overall survival. In a large clinical trial called VISION, participants who received 177Lu-PSMA-617a type of drug called a radiopharmaceuticalalong with standard treatments lived longer than those who received only standard therapies. As PSMA is highly expressed in prostate cancer and mCRPC lesions, the combination of PSMA-617 with the beta-emitter lutetium allows for the targeted delivery of -particle radiation to PSMA-expressing cells and In March 2021, Novartis announced that the VISION trial (NCT03511664), which tested the efficacy and safety of lutetium (Lu)-177 PSMA-617 After first infusion PSA dropped from 375 to 105. andrew j. armstrong, md, msc: the vision clinical trial was a phase 3 global study that looked at the safety and global efficacy of psma [prostate-specific membrane antigen] lutetium 177, which is a small molecule that binds to psma on the cell surface of prostate cancer cells, and delivers a beta emitter, called lutetium-177, that emits In the fourth interview of the series, Jorge Garcia, MD, FACP, discusses the VISION trial, how LuPSMA fits within the current mCRPC treatment landscape, and implications of VISIONs results for prostate cancer therapy. Lancet Oncol 2018;19(6):82533; The VISION trial and how it will provide the basis for better models for integrating prostate-specific membrane antigen (PSMA) into the management of patients with advanced prostate cancer was discussed at last Decembers 2021 Society of Urologic Oncology (SUO) annual meeting by Michael J. Morris MD, Section Head of Prostate Cancer of the Genitourinary ; The findings warrant adoption of 177 Lu-PSMA-617 as a new treatment option for metastatic We have just been appraised of a randomized, double-blind, multi-center, Phase III clinical trial of the targeted, radiolabeled agent 177Lu-PSMA-617 (a form of "radioligand" therapy) in the treatment of metastatic, castration-resistant prostate cancer (mCRPC). 1. 2022 Jan 27;jnumed.121.263638. The trial was conducted in Very excited about these results but then my CT scan and bone scan taken last week indicated cancer progression in bone Mets, new Mets on spine but some reduction in lymph node activity. The VISION trial randomized patients with at least one PSMA-PET positive metastatic lesion and no PSMA-negative metastatic lesions above a certain threshold (see below) to receive either Lu-PSMA plus ongoing standard of care or standard of Details about this trial can be found on the ClinicalTrials.gov web site. Why We Did What We Did: PSMA-PET/CT Selection Criteria for the VISION Trial. The clinical trial, called VISION, involved more than 800 patients with advanced prostate cancer who had been previously treated with chemotherapy and hormone therapy. This is a prospective, open-label, multi-center, randomized, Phase 3 study evaluating Lutetium 177Lu-PSMA-I&T as treatment compared to standard of care hormone therapy in men with metastatic Castration-Resistant Prostate Cancer. (sept. 16 issue), 1 the use of lutetium-177 ( 177 lu)psma-617, a radioligand that 177Lu-PSMA-617 versus docetaxel in chemotherapy-nave mCRPC: a randomized, controlled, phase 2 non inferiority trial. A. Oliver Sartor , Michael J. Morris , Bernd J Krause Show More Abstract Disclosures Abstract TPS5099 Are these seemingly conflicting results normal. PSMA-targeted imaging has demonstrable value in guiding the management of the clinical evolution of prostatic cancer. A possible advantage of the imaging criteria that were used in our trial is that they allow patients with PSMA-positive metastatic castration-resistant prostate cancer to receive life-extending therapy on the basis of only one PET scan plus conventional imaging. A 40% reduction in the risk of death was observed when 177Lu-PSMA-617A was added to standard of care therapy in patients with PSMA-positive metastatic castration-resistant prostate cancer. Basel, March, 23, 2021 Novartis today reported the first interpretable results of the Phase III VISION study evaluating the efficacy and safety of 177 Lu-PSMA-617, a targeted radioligand therapy in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) compared to best standard of care alone. VISION: An International, Prospective, Open Label, Multicenter, Randomized Phase 3 Study of 177Lu-PSMA-617 in the Treatment of Patients With Progressive PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC) Actual Study Start Date : May 29, 2018: Actual Primary Completion Date : January 27, 2021: Estimated Study Completion Date : And some men with prostate cancer have more of the protein than others. A scientific session presented at the Society of Nuclear Medicine and Molecular Imaging meeting detailed the use of Lutetium-177-PSMA-617 (177 Lu-PSMA-617), a prostate-specific membrane antigen (PSMA) radioligand therapy, and results from the VISION trial, which found that the therapy prolonged survival when used in conjunction with standard care in The SWOG S1216 trial was a federally funded trial in men with metastatic hormone-sensitive prostate cancer. Addition of 177Lu-PSMA-617 therapy to standard of care for patients with metastatic castration-resistant prostate cancer (mCRPC) significantly improves survival, according to results from the randomized, phase 3 VISION trial. Novartis has reported the first interpretable, positive results from the Phase III VISION study of investigational PSMA-targeted radioligand therapy, 177 Lu-PSMA-617, in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). Whats exciting about lutetium therapy is that its delivered straight to cancer cells through an innovative mechanism that reduces side-effects and can help extend the life of men with advanced prostate cancer. A new cancer treatment that uses engineered radioactive molecules to target prostate cancer cells and inhibit tumor growth extended survival for patients with advanced prostate cancer, according to newly announced results of the VISION trial.
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vision trial prostate