Efficacy and safety of Lutetim-177-PSMA-617 therapy in paitents with metastatic prostate cancer after radical prostatectomyand bilateral orchitectomy

Efficacy and safetyof Lutetim-177-PSMA-617 therapy in paitents with metastatic prostate cancer after radical prostatectomyand bilateral orchitectomy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230414057906N1

Enrollment

Registered

2023-04-23

Start date

2023-05-05

Completion date

Unknown

Last updated

2023-05-01

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

Conditions

Prostate cancer. Malignant neoplasm of prostate

Interventions

At first, PSMA-617 is labeled with LU-177 chloride. LU-PSMA is infused at the rate of -7.4GBq within 30-60 seconds along with one liter of normal saline serum. All the standard measures of lutetium th

Eligibility

Sex/Gender

Male

Age

20 Years to 85 Years

Inclusion criteria

Inclusion criteria: Men with metastatic prostate cancer after radical prostatectomy and bilateral orchitectomy 68Ga-PSMA-PET/CT positive scan Having willingness to participate in this study

Exclusion criteria

Exclusion criteria: Creatinine >=2 mg/dl Obstructive DTPA SCAN GFR=30 WBC=2000 Hb=8g/dl Previous history of chemotherapy/radiotherapy for prostate cancer PLAT=75000 ALT/AST >5 times of upper normal limit for those with liver metastasis or <2 times for those without liver metastasis. Patients with life expectancy <12 weeks

Design outcomes

Primary

Measure	Time frame
(prostate specific antigen)PSA. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Blood test.;Bone pain Score. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Visual Analog Scale.;Alkaline phosphatase. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Blood test.;White blood cells. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Blood test.;Hemoglobin. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Blood test.;Platelet count test. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Blood test.;Blood urea nitrogen. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Blood test.;Creatinine. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Blood test.;Aspartate aminotransferase. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Blood test.;Alanine transaminase. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Blood test.;Lactate dehydrogenase. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Blood test.	—

Measure

Time frame

(prostate specific antigen)PSA. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Blood test.;Bone pain Score. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Visual Analog Scale.;Alkaline phosphatase. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Blood test.;White blood cells. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Blood test.;Hemoglobin. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Blood test.;Platelet count test. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Blood test.;Blood urea nitrogen. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Blood test.;Creatinine. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Blood test.;Aspartate aminotransferase. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Blood test.;Alanine transaminase. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Blood test.;Lactate dehydrogenase. Timepoint: Before study, 2 and 4 months after Lutetium. Method of measurement: Blood test.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaber Amanollahi Soudmand

Shahid Beheshti University of Medical Sciences

saberas_2008@yahoo.com+98 21 23871

Outcome results

None listed

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