NCT02673151

68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment

68-Ga PSMA 11 PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy in Patients With Elevated PSA

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Andrei Iagaru · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to see if recurrent prostate cancer can be identified using a special procedure called a positron emission tomography (PET) scan. PET/CT is used to describe information regarding the function, as well as location and size of a tumor.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate 68Ga-PSMA-11 PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated PSA. PSMA refers to prostate-specific membrane antigen. Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-PSMA-11 and undergo a PET/CT. Participants will be contacted at 24 to 72 hours following the scan in order to capture potential late occurring adverse events. Clinical follow up of participant at 3 to 12 months following the scan in order to analyze secondary endpoints.

Conditions

• Prostate Adenocarcinoma
• PSA Failure
• Recurrent Prostate Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography (CT) scan	PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).
DRUG	68Ga-PSMA-11	68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11), administered by intravenous (IV) injection.
PROCEDURE	Positron Emission Tomography (PET)	PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).

Timeline

• Start date: 2017-05-20
• Primary completion: 2018-04-27
• Completion: 2019-04-27
• First posted: 2016-02-03
• Last updated: 2022-01-13
• Results posted: 2022-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study