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Study record managers: refer to the Data Element Definitions if submitting registration or information. Novel androgen axis drugs [NA] such as abiraterone or enzalutamide are allowed. The study is open-label and patients will be monitored throughout the 6 to month treatment period for survival, disease progression, and adverse events. A long-term follow-up period will include the collection of rPFS survival and information about new treatments, responses to new treatments, adverse events assessment, as well as blood for hematology and chemistry testing.
An End of Treatment visit should occur once a patient discontinues the treatment part of the study for any reason patient or investigator decision, going on to long term follow up, etc. The planned enrollment for this study is patients. In order to not bias the obtained from randomized patients in the main study, the data of the sub-study patients will be analyzed descriptively and not considered in the primary and secondary analysis of the main study.
Patients treated with only 1 prior taxane regimen are eligible if the patient is unwilling or the patient's physician deems the patient unsuitable to receive a second regimen. After 4 cycles, patients will be assessed for 1 evidence of response, 2 residual disease, and 3 tolerance to Lu-PSMA Higher scores indicated greater levels of problems across each of the five dimensions. The total score range is betweenhigher scores indicates better for total score and subscale scores.
PCS is a item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer Rangehigher scores better. Higher scores indicate higher degree of functioning and better quality of life. BPI-SF is an item self report questionnaire that is deed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 questions inquiring about the extent of pain, where the extent is ranked from 0 [no pain] to 10 [pain as bad as you can imagine]. Talk with your doctor and family members or friends about deciding to a study.
To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information. Search for terms. Save this study. Warning You have reached the maximum of saved studies Listing a study does not mean it has been evaluated by the U.
Federal Government. Read our disclaimer for details. Last Update Posted : July 27, Study Description. Detailed Description:. MedlinePlus related topics: Prostate Cancer. FDA Resources. Arms and Interventions. Outcome Measures. Time to SSE is defined as the date of randomization to the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first. PFS is defined as the time from date of randomization to the date of first documented progression by investigator assessment radiographic progression, clinical progression, PSA progression or death from any cause, whichever occurs first.
EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Patients must have the ability to understand and comply with all protocol requirements.
Patients must have an ECOG performance status of 0 to 2. Patients must have been ly treated with at least 1, but no more than 2 taxane regimens. A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. If a patient has received only 1 taxane regimen, the patient is eligible if: a. The patient's physician deems him unsuitable to receive a second taxane regimen e.
The minimal start value is 2. Patients must have adequate organ function: a. PSMA-targeted radioligand therapy is not allowed. Any systemic anti-cancer therapy e. Any investigational agents within 28 days prior to day of randomization. Known hypersensitivity to the components of the study therapy or its analogs. Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy. Transfusion for the sole purpose of making a subject eligible for study inclusion.
Patients with a history of CNS metastases must have received therapy surgery, radiotherapy, gamma knife and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity.
Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. A superscan as seen in the baseline bone scan. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
Concurrent serious as determined by the Principal Investigator medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or other ificant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation. Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment.
However, patients with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are patients with adequately treated non-melanoma skin cancer, superficial bladder cancer. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. N Engl J Med. Lutetium prostate-specific membrane antigen PSMA theranostics: practical nuances and intricacies. Prostate Cancer Prostatic Dis. Epub Oct 8. National Library of Medicine U.
National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Prostate Cancer. Phase 3. Study Type :. Interventional Clinical Trial. Actual Enrollment :. The study population includes patients with progressive PSMA-positive mCRPC who received at least one novel androgen axis drug [NAAD] such as enzalutamide or abiraterone and were ly treated with 1 to 2 taxane regimens. Actual Study Start Date :. Actual Primary Completion Date :. Estimated Study Completion Date :. Drug: Lu-PSMA administered intravenously once every 6 weeks 1 cycle for a maximum of 6 cycles. Los Angeles, California, United States, Washington, District of Columbia, United States, Saint Louis, Missouri, United States, Philadelphia, Pennsylvania, United States, Hospital rechts der Isar, Department of Nuclear Medicine.
Sahlgrenska University Hospital, Department of Oncology. April 30, Key Record Dates. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies.
These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.
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