Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04483414
Status:
WITHDRAWN
Last Update Posted:
2023-05-19
First Post:
2020-07-20
Brief Title:
68Ga PSMA-11 PETCT in Recurrent Prostate Cancer
Sponsor:
Dana Mathews
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was closed since no participants were enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this research is to examine the ability of Gallium-68 68Ga Prostate-Specific Membrane Antigen-11 PSMA-11 positron emission tomographycomputed tomography PETCT 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 PETCT 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
This study is designed to evaluate the performance of 68Ga PSMA-11 PETCT 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None