68Ga-PSMA PET-CT Scan for Diagnosis and Management of Prostate Cancer

Phase 2

• Conditions: Prostate Cancer
• Interventions: Drug: 68Ga-PSMA

• Registration Number: NCT02282137
• Lead Sponsor: Ebrahim Delpassand

Brief Summary

This is a phase II clinical trial study to show how well the 68Ga-PSMA-11 (ProstaMedix™) PET-CT scan works in detecting tumor location and size in patients with suspected or confirmed prostate cancer, as well as prostate cancer that may have come back in patients with elevated PSA ( a prostate-specific antigen tumor marker) after initial treatment.

Detailed Description

68Ga-PSMA-11 is a radioactive imaging contrast agent for use in PET CT scan that seeks to identify prostate cancer cells that have a specific protein target called prostate-specific membrane antigen (PSMA) on their surface. PET and CT make computerizing pictures of areas inside the body where the radioactive substance is lighting up. 68Ga-PSMA-11 PET / CT may be able to see smaller tumors than standard imaging and may help determine whether prostate cancer has come back and where it is in the body.

A 68Ga-PSMA-11 PET / CT scan may help doctors to better detect the location, extent, and characteristics of the tumor, allowing improved planning of subsequent therapy

Study Timeline

• Study First Submitted: 2014-10-27
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-04
• Study Start: 2015-05
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-17
• Last Update Posted: 2020-08-19
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 208

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-PSMA	68Ga-PSMA	Evaluation of concordance and discordance between the results of 68Ga-PSMA PET/CT and other available conventional imaging modalities (such as CT, MRI, FDG, NaF scan), histology or follow up.

Primary Outcome Measures

Name	Time	Method
The sensitivity of 68Ga-PSMA-11 PET for detection of tumor location.	12 months	The sensitivity of 68Ga-PSMA-11 PET to detect tumor location and metastases in patients with biopsy confirmed diagnosis.tumor location confirmed by histopathology/biopsy and conventional imaging follow-up.

Secondary Outcome Measures

Name	Time	Method
Detection rates of 68Ga-PSMA-11 PET in patients with different PSA value	12 months	Detection rates of 68Ga-PSMA-11 PET in patients with different PSA value (0.2 - \<0.5, 0.5 - \<1.0, 1.0 - \<2.0, 2.0 - \<5.0, 5.0).

Trial Locations

Locations (1)

Radio- Isotope Therapy of America; 🇺🇸 Houston, Texas, United States