Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-01-12 @ 12:55 PM
Study NCT ID:
NCT03362359
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2017-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ga-68-PSMA-11 in High-risk Prostate Cancer
Sponsor:
German Cancer Research Center
Organization:
Study Overview
Official Title:
An Open-label, Single-arm, Rater-blinded, Multicenter Phase 1/2 Study to Assess Safety and Diagnostic Accuracy and Radiotherapeutic Implications of Pre-operative Ga-68-PSMA-11 PET/CT Imaging in Comparison to Histopathology, in Newly-diagnosed Prostate Cancer (PCA) Patients at High Risk for Metastasis, Scheduled for Radical Prostatectomy (RP) With Extended Pelvic Lymph Node Dissection (EPLND)
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be an open-label, single-arm, rater-blinded, multicenter, diagnostic phase 1/2 study to assess safety and diagnostic performance of Ga-68-PSMA-11 positron emission tomography / computer tomography (PET/CT) imaging to detect tumour tissue in patients with newly diagnosed PCA and a high risk for metastasis. As standard of truth, comprehensive histopathology covering prostate and the tributary pelvic lymph node system, will be used. Therefore, only patients scheduled for RP with EPLND (as part of their standard of care) will be eligible.
Patients will be recruited at up to 11 uro-oncological sites in Germany, Austria, and Switzerland, with access to a radiopharmaceutical laboratory, experienced to prepare 68Ga-labelled compounds, and high-quality PET/CT imaging. Upon histological confirmation of PCA, pre-operative staging will be performed according to European Association of Urology (EAU) guideline \[Mottet et al. 2015\] (to include pelvic MRI or CT and a 99mTc-bone scan), to establish the indication for RP with EPLND. If the indication is confirmed, patients will be invited to participate in the present study. After consenting, review of inclusion and exclusion criteria, as well as screening investigations will be performed by the uro-oncologist (day 0). Thereafter, patients are referred to the collaborating nuclear medicine department for tracer injection, imaging, and post-dose safety evaluations (day 1). Subsequent investigations (day 2 and at end of study) will be made by the uro-oncologist or experienced nuclear medicine physician. Study participation ends on day 7. Routine surgery (RP with EPLND) will be performed after end of study, but no later than 42 days after study inclusion. This sequence allows adequate characterisation of tracer safety, while at the same avoiding unnecessary delay of, or confounding safety signals from therapy.
In total, 150 evaluable patients will be included to receive a single 68Ga dose of 150 MBq (± 50 MBq), administered as i.v. infusion. Due to an assumed dropout rate of 15%, up to 173 patients will be included in study.
Patients will be recruited at up to 11 uro-oncological sites in Germany, Austria, and Switzerland, with access to a radiopharmaceutical laboratory, experienced to prepare 68Ga-labelled compounds, and high-quality PET/CT imaging. Upon histological confirmation of PCA, pre-operative staging will be performed according to European Association of Urology (EAU) guideline \[Mottet et al. 2015\] (to include pelvic MRI or CT and a 99mTc-bone scan), to establish the indication for RP with EPLND. If the indication is confirmed, patients will be invited to participate in the present study. After consenting, review of inclusion and exclusion criteria, as well as screening investigations will be performed by the uro-oncologist (day 0). Thereafter, patients are referred to the collaborating nuclear medicine department for tracer injection, imaging, and post-dose safety evaluations (day 1). Subsequent investigations (day 2 and at end of study) will be made by the uro-oncologist or experienced nuclear medicine physician. Study participation ends on day 7. Routine surgery (RP with EPLND) will be performed after end of study, but no later than 42 days after study inclusion. This sequence allows adequate characterisation of tracer safety, while at the same avoiding unnecessary delay of, or confounding safety signals from therapy.
In total, 150 evaluable patients will be included to receive a single 68Ga dose of 150 MBq (± 50 MBq), administered as i.v. infusion. Due to an assumed dropout rate of 15%, up to 173 patients will be included in study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: