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IRCT20211206053304N2 IRCT 2024-02-27 Iran University of Medical Sciences The efficacy assessment of 225Ac-PSMA-617 in Prostate cancer treatment. AcPC The preliminary evaluation of therapeutic efficacy of 225Ac-PSMA-617 in patients of metastatic castrate resistant prostate cancer 2024-02-17 anticipated 10 Complete https://irct.ir/trial/75549 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1-2 metastatic castration-resistant Prostate Cancer(CRPC). The treatment method in this study involves the use of therapeutic radiopharmaceutical Alpha-225Ac-PSMA. Patients with treatment-resistant prostate cancer receive the radiopharmaceutical therapy on the treatment day in the nuclear medicine department. The radiopharmaceutical provided by the manufacturer (Pars Isotope) is administered intravenously after hydrating the patient with approximately one liter of normal saline. The treatment starts with an activity of 100 kBq/kg based on the patient's weight, repeated every 8 weeks for three cycles or until evidence of disease progression, unacceptable toxicity, or patient refusal to continue the treatment, whichever comes first.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The study is in the initial evaluation phase, and the executor along with colleagues intend to publish the study as an article.
public Dr. Leila Hassanzadeh
Number 3, Unit 12, Homa Alley, Shahid Hafizi Street, Qods Town
Tehran Iran (Islamic Republic of) 1468793336 +98 21 2265 8575 hassanzadeh.l@iums.ac.ir Iran University of Medical Sciences scientific Leila Hassanzadeh
Unit 12, No. 3, Homa Alley, Hafezi Ave., Farahzadi Blvd.,
Tehran Iran (Islamic Republic of) 1468793336 +98 21 8670 5503 hassanzadeh.l@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Castration-resistant metastatic adenocarcinoma of the prostate should be confirmed by histopathology tests at the time of initial diagnosis If a patient is in the metastatic stage of prostate cancer mCRPC and has cancerous lesions in distant areas, the primary site of the disease is present. Cancerous lesions in imaging studies with 68Ga-PSMA-11 or 99mTc-PSMA-11 may demonstrate a higher uptake of the radiopharmaceutical than the uptake in normal liver tissue over the course of 4 weeks before treatment. The patient may have previously received second-generation androgen deprivation therapies (Enzalutamide, Abiraterone), or it may not have been possible for the patient to receive them. The patient may have received taxane-based treatments, or it may not have been appropriate to treat them with taxanes. The patient has been treated with the beta-emitting radiopharmaceutical 177Lu-PSMA-617. Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2." Patients' GFR should be above 30 no limit no limit Male Low bone marrow function :Hemoglobin concentration of <۹ g/dL,platelet count of <۱۰۰ × ۱۰۹/L, orwhite blood cell count of <۲.۰ × ۱۰۹/L), ANS<۱.۵×۱۰۹/ Low Kidney function: glomerular filtration rate of less than 30 mL/min/1.73 m۲ of body surface area;Serum/plasma creatinine˃1.5×ULN or creatinin clearance<50 ml/min based on cockcroft-Gault formula Low Liver function is defined(Albumin less than 2.5 g/dL, Billirubin˃3×ULN و یا َAlanine aminotransferase (ALT) or aspartate aminotransferase (SAT)˃3.۰×ULN . Patients who do not have cancer lesions that absorb radioactivity in PET or SPECT imaging Patients whose histology from the sampled tissue indicates sarcomatous/spindle cell/small cell differentiation. Untreated patients with kidney obstruction Patients with active secondary malignancy Patients with Chronic or acute glomerulonephritis Patients who have received chemotherapy, wide-field radiotherapy, and radiopharmaceuticals in the last 8 weeks are excluded from the study. C61 Malignant neoplasm of prostate Treatment - Drugs The treatment method in this study involves the use of therapeutic radiopharmaceutical Alpha-225Ac-PSMA. Patients with treatment-resistant prostate cancer receive the radiopharmaceutical therapy on the treatment day in the nuclear medicine department. The radiopharmaceutical provided by the manufacturer (Pars Isotope) is administered intravenously after hydrating the patient with approximately one liter of normal saline. The treatment starts with an activity of 100 kBq/kg based on the patient's weight, repeated every 8 weeks for three cycles or until evidence of disease progression, unacceptable toxicity, or patient refusal to continue the treatment, whichever comes first. PSA level measurement. Timepoint: Before treatment and every four weeks after receiving the radiopharmaceutical. Method of measurement: Blood Test. Iran University of Medical Sciences Approved 2023-11-20 School of medicine, IRAN University of Medical Sciences Hemmat Highway, next to Milad Tower, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)