The efficacy assessment of 225Ac-PSMA-617 in Prostate cancer treatment.

Phase 1

Recruiting

Conditions: metastatic castration-resistant Prostate Cancer(CRPC).
Malignant neoplasm of prostate

Registration Number: IRCT20211206053304N2

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

Low bone marrow function :Hemoglobin concentration of g/dL,platelet count of <??? × ???/L, orwhite blood cell count of <?.? × ???/L), ANS<?.?×???/<brLow Kidney function: glomerular filtration rate of less than 30 mL/min/1.73 m? 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 ? ?? ?Alanine aminotransferase (ALT) or aspartate aminotransferase (SAT)?3.?×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.