Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer ( VISION) Brief Summary: Detailed Description: Patients with PSMA positive scans

Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer (VISION) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

177 Lu-PSMA-617 has been introduced before in this column as a PSMA-targeted radioligand therapy. 1 A Phase II Australian trial treated 30 men with metastatic castration-resistant prostate cancer who had variable lines of exposure to agents such as abiraterone, enzalutamide, docetaxel and/or cabazitaxel. 2 Seventeen (57%) patients achieved a prostate-specific antigen (PSA) decline ≥50%. [177Lu]Lu-PSMA-617 compared with cabazitaxel in men with metastatic castration-resistant prostate cancer led to a higher PSA response and fewer grade 3 or 4 adverse events. [177Lu]Lu-PSMA-617 is a new effective class of therapy and a potential alternative to cabazitaxel.

Lu-psma-617 vision

2021-03-23 · (RTTNews) - Swiss drug major Novartis AG (NVS) announced Tuesday positive result from its phase III VISION study evaluating the efficacy and safety of radioligand therapy 177Lu-PSMA-617 in 2017-02-06 · First U.S. Multi-center Investigational Clinical Trial of 177 Lu PSMA-617 Targeted Radioligand Therapy in Metastatic Castration Resistant Prostate Cancer Receives FDA Clearance 2021-03-23 · About VISION VISION is an international, prospective, randomized, open-label, multicenter, phase III study to assess the efficacy and safety of ^177Lu-PSMA-617 (7.4 GBq administered by i.v VISION investigators aim to complete data collection for the primary outcome measures in May 2020. 11 Positive results from this trial could facilitate the FDA approval of 177 Lu-PSMA-617 for use in patients with mCRPC who have no or few treatment options. There were no treatment-related deaths. The most common toxic effects related to [177 Lu]-PSMA-617 were grade 1 dry mouth recorded in 26 (87%) patients, grade 1 and 2 transient nausea in 15 (50%), and G1-2 fatigue in 15 (50%). Grade 3 or 4 thrombocytopenia possibly attributed to [177 Lu]-PSMA-617 occurred in 177 Lu‐PSMA‐617 offers a potential additional life‐prolonging treatment option for men with mCRPC. The results of this trial will determine, for the first time in a randomized design, the activity and safety of 177 Lu‐PSMA‐617, as compared with cabazitaxel chemotherapy in men with progressive mCRPC. 2 dagar sedan · Clinical trials are research studies that involve people.

2020-02-16

infusion every 6 weeks for a maximum of 6 cycles) plus investigator-chosen best standard of care in the investigational arm, versus best standard of care in the control arm 1 7. 2021-03-23 · 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.

Endocyte, Inc. recently announced the enrollment of the first patient in its global phase 3 VISION trial of 177Lu-PSMA-617 in prostate cancer by Dr. Luke

infusion every 6 weeks for a maximum of 6 cycles) plus investigator-chosen best standard of care in the investigational arm, versus best standard of care in the control arm(1) (7) . PSMA-617 Lu-177 | C49H68LuN9O16 | CID 122706785 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological 177 Lu‐PSMA‐617 offers a potential additional life‐prolonging treatment option for men with mCRPC. The results of this trial will determine, for the first time in a randomized design, the activity and safety of 177 Lu‐PSMA‐617, as compared with cabazitaxel chemotherapy in men with progressive mCRPC. 2021-03-23 Swiss drug major Novartis AG announced Tuesday positive result from its phase III VISION study evaluating the efficacy and safety of radioligand therapy 177Lu-PSMA-617 in patients with advanced prostate cancer.The trial met both primary endpoints of overall survival and radiographic progression-free survival. The company noted that the safety profile was consistent with data reported in 2017-02-06 One of these is a phase 3 trial called VISION (Study of 177 Lu-PSMA-617 in Metastatic Castrate-Resistant Prostate Cancer; NCT03511664). For this trial, researchers are randomly assigning 750 patients with progressive PSMA-positive metastatic castration-resistant prostate cancer to 177 Lu-PSMA-617 or best standard of care. We saw recently (see this link) that of chemo and hormonal medicines for metastatic castration-resistant prostate cancer (mCRPC), Jevtana (cabazitaxel) is the preferred third treatment after Taxotere (docetaxel) and Zytiga (abiraterone) or Xtandi (enzalutamide).But when should radiopharmaceuticals, either approved ones like Xofigo (Ra-223), or prospective ones like Lu-177-PSMA-617, be used in 2018-10-18 2021-03-23 If [the VISION study] is positive, then Lu-PSMA-617 could have a considerable impact on care for that space.

Målet är dessutom att tillverka terapisubstansen Lu-. 177 PSMA för behandling av prostatacancer som spridit sig. Med egen HUS vision är att verka som vägvisare inom hälso- och sjukvården. Vårt löfte. Vi ger ett löfte åt 821 617. 850 000. 860 000. 875 000.
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Kabasakal et al. Pre-therapeutic dosimetry of normal organs and tissues of (177)Lu-PSMA-617 prostate-specific membrane antigen (PSMA) inhibitor in patients with castration-resistant prostate cancer.

In the Phase III VISION trial, researchers examined the efficacy and safety of 177 Lu-PSMA-617, an investigational PSMA-targeted radioligand therapy, in patients with advanced prostate cancer. The radioligand treatment approach from Novartis uses a targeting compound which can bind to markers expressed by tumors and a radioactive isotope.
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Preliminary clinical data indicates that 177 Lu-PSMA-617 may demonstrate clinical benefit in patients with mCRPC in a setting where patients had no clear standard of care. VISION (NCT03511664) is a phase 3 study designed to assess the efficacy of 177 Lu-PSMA-617 in patients with PSMA-positive mCRPC.

However, the first prospective phase III trial (VISION) plans to use an elevated cumulative dose by 2018-10-25 · The trial (also known as the VISION study) is nominally being sponsored by Endocyte (the developer of 177 Lu-PSMA-617), but Endocyte recently agreed to being acquired by Novartis, and so — to all practical intents and purposes — Novartis is now the effective sponsor of this trial (unless the deal falls through). 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 VISION (NCT03511664) is a phase 3 study designed to assess the efficacy of 177 Lu-PSMA-617 in patients with PSMA-positive mCRPC.

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Dosimetri för Lu-177-PSMA-6172020Independent thesis Advanced level (degree of Master (Two Years)), 20 credits / 30 HE creditsStudent thesis. Abstract [en].

infusion every 6 weeks for a maximum of 6 cycles) plus investigator-chosen best standard of care in 2021-02-27 · We await the results of the VISION trial, a phase 3 randomised trial comparing [177 Lu]Lu-PSMA-617 to best standard of care or best supportive care. TheraP will provide complementary data because cabazitaxel was not included in the standard-of-care group in the VISION trial. Phase 3 (VISION) study of Lu-PSMA-617 in mCRPC: - 1st patient enrollment 2Q 2018.

(RTTNews) - Swiss drug major Novartis AG (NVS) announced Tuesday positive result from its phase III VISION study evaluating the efficacy and safety of radioligand therapy 177Lu-PSMA-617 in

Methods: Patients were randomized 2:1 to receive best standard of care with or without 177 Lu-PSMA-617. 2020-02-16 · 1.

Kabasakal L, AbuQbeitah M, Aygün A, et al.