Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-01-02 @ 12:34 PM
Study NCT ID:
NCT06392295
Status:
RECRUITING
Last Update Posted:
2025-06-15
First Post:
2024-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer
Sponsor:
University of Miami
Organization:
Study Overview
Official Title:
A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN Trial
Status:
RECRUITING
Status Verified Date:
2025-06
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:
OCEAN
Brief Summary:
The purpose of this prostate cancer research study is to learn about:
1. Improving control of prostate cancer using radiation therapy, delivered to the para-aortic and pelvic lymph nodes, in addition to systemic androgen suppression therapy;
2. Preserving quality of life after radiation therapy;
3. Leveraging imaging results from prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) scans to evaluate and manage disease progression.
1. Improving control of prostate cancer using radiation therapy, delivered to the para-aortic and pelvic lymph nodes, in addition to systemic androgen suppression therapy;
2. Preserving quality of life after radiation therapy;
3. Leveraging imaging results from prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) scans to evaluate and manage disease progression.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: