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

The preliminary evaluation of therapeutic efficacy of 225Ac-PSMA-617 in patients of metastatic castrate resistant prostate cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20211206053304N2
Enrollment
10
Registered
2024-02-27
Start date
2024-02-17
Completion date
Unknown
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 th

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion 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

Exclusion criteria: Low bone marrow function :Hemoglobin concentration of <? g/dL,platelet count of <??? × ???/L, orwhite blood cell count of <?.? × ???/L), ANS<?.?×???/ Low 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.

Design outcomes

Primary

MeasureTime frame
PSA level measurement. Timepoint: Before treatment and every four weeks after receiving the radiopharmaceutical. Method of measurement: Blood Test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Leila Hassanzadeh

Iran University of Medical Sciences

hassanzadeh.l@iums.ac.ir+98 21 2265 8575

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026