Status:
RECRUITING
99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Prostate Carcinoma
Recurrent Prostate Carcinoma
Eligibility:
MALE
Phase:
EARLY_PHASE1
Brief Summary
This exploratory study conducted under the RDRC program studies the biodistribution of 99mTc-PSMA-I\&S in patients with prostate cancer who undergo pelvic lymph node dissection. Prostate specific memb...
Detailed Description
PRIMARY OBJECTIVE: I. To define the biodistribution of 99mTc-based PSMA imaging and surgery agent (99mTc-PSMA-I\&S) in normal and malignant tissues of patients with prostate cancer (PCa) with histopa...
Eligibility Criteria
Inclusion
- Men with PCa (primary or recurrent disease)
- Men who received a 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) for staging or restaging
- Men with evidence of lymph nodes (LNs)-positive disease on 68Ga-PSMA-11 PET/CT
- Men who are scheduled for pelvic LN dissection (PLND)
- Men who can provide oral and written informed consent
- Men who can comply with study procedures
Exclusion
- Patients who started any PCa treatment between study enrollment and surgery
- Technically inaccessible nodal location
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04857502
Start Date
April 27 2021
End Date
June 1 2027
Last Update
July 15 2025
Active Locations (1)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095