IRCT20211206053304N2
Recruiting
Phase 1
The preliminary evaluation of therapeutic efficacy of 225Ac-PSMA-617 in patients of metastatic castrate resistant prostate cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Iran University of Medical Sciences
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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