Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449781
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2023-12-06
Brief Title:
177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer
Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Organization:
Maria Sklodowska-Curie National Research Institute of Oncology
Study Overview
Official Title:
177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High- and Very High-risk Prostate Cancer After Radical Treatment Using Locoregional Teleradiotherapy and Hormone Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
PSMA-ADJUVO
Brief Summary:
Single-center non-commercial phase 2 clinical trial to evaluate 177Lu-PSMA as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment using locoregional teleradiotherapy and hormone therapy
Detailed Description:
The intervention will consist of a single administration of 177Lu-PSMA with an activity of 74 GBq in the research arm Both the study and control groups will receive standard hormone therapy
The study population includes 200 adult men with high-risk or very high-risk prostate cancer with no signs of cancer dissemination in radiological examinations after completion of radiotherapy and continued hormone therapy
Participation time in the Study
intervention phase - 1 day observation phase - 5 years
The study population includes 200 adult men with high-risk or very high-risk prostate cancer with no signs of cancer dissemination in radiological examinations after completion of radiotherapy and continued hormone therapy
Participation time in the Study
intervention phase - 1 day observation phase - 5 years
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Nr EU CT 2023-504912-13-00 | OTHER | EMA | None |