NCT04483414

68Ga PSMA-11 PET/CT in Recurrent Prostate Cancer

The Role of 68Gallium PSMA-11 in Biochemical Recurrence in Prostate Cancer and in Known Metastatic Prostate Cancer and in the Evaluation of Treatment Response After Salvage Therapy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dana Mathews · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this research is to examine the ability of Gallium-68 (68Ga) Prostate-Specific Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to detect sites of recurrent prostate cancer in patients with biochemical recurrence previously treated with radical prostatectomy (RP) or external beam radiation (EBRT) and to assess treatment response to subsequent salvage therapy.

Detailed description

In developed countries, prostate cancer is the most common malignancy in men and the third leading cause of death in men. Following primary therapy for prostate cancer, a substantial number of patients will recur either locally in the pelvis or in extra pelvic locations. Approximately 20-30% of patients' status post RP will recur and up to 60% patients treated with EBRT will recur, as detected by rising serum levels of prostate specific antigen (PSA) after original therapy. This phenomenon is referred to as biochemical recurrence (BCR), as the elevated PSA usually occurs in advance of obvious clinical or radiologic evidence. This study is designed to evaluate the performance of 68Ga PSMA-11 PET/CT in detecting the location (localized versus extra pelvic) of BCR and advanced metastatic prostate cancer compared to conventional imaging. In addition, we will evaluate its performance in assessing interim and post salvage therapy response compared to conventional imaging, including pelvic magnetic resonance imaging (MRI), computed tomography (CT), and bone scintigraphy.

Conditions

• Prostate Cancer
• Prostate Cancer Metastatic
• Prostate Cancer Metastatic to Bone

Interventions

Type	Name	Description
DRUG	68Ga PSMA-11 injection	Injection of 68Ga PSMA-11
PROCEDURE	Positron Emission Tomography/Computed Tomography	PET/CT scan after 68Ga PSMA-11 injection

Timeline

• Start date: 2021-03-19
• Primary completion: 2023-04-05
• Completion: 2023-04-05
• First posted: 2020-07-23
• Last updated: 2023-05-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study