Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2025-12-29 @ 10:35 PM
Study NCT ID:
NCT07291557
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PSMA-PET Directed Radiation Therapy for High-Risk Prostate Cancer
Sponsor:
AHS Cancer Control Alberta
Organization:
Study Overview
Official Title:
PSMA-PET Directed Radiation Therapy in High and Very High-Risk Prostate Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
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:
None
Brief Summary:
In this study, prostate cancer patients whose cancer has not spread to the lymph nodes will receive radiation therapy targeted to the prostate and nearby tissues with or without whole pelvis radiation therapy. PSMA imaging will be used to visualize prostate cancer prior to starting the trial.
Detailed Description:
The current treatment of high risk and very high risk localized prostate cancer is by radiation therapy (RT) and hormone therapy (ADT). RT uses radiation to kill the cancer cells while hormone therapy lowers the levels of male hormones like testosterone, which the cancer needs to grow. Radiation is targeted to the prostate and nearby tissues, which may or may not include whole pelvis radiation therapy (WPRT). The benefit of whole pelvis radiation therapy is not well understood. Therefore, clinical research is needed to assess the benefits/risks of whole pelvis radiation therapy in prostate cancer treatment. In addition to traditional cancer imaging methods like CT, MRI, and bone scan, new techniques like PSMA imaging are now available to examine prostate cancer. The PSMA scan involves a small amount of radioactive tracer (18F-PSMA-1007) being injected into the vein, which marks the prostate cancer cells for better visualization of the cancer location and spread. Because of its higher accuracy, results of PSMA scans can change how doctors plan cancer treatment, like where they aim radiation and how much they use.
In this study, prostate cancer patients whose cancer has not spread to the lymph nodes will receive radiation therapy. PSMA imaging will be used to visualize prostate cancer prior to starting the trial.
There will be two treatment groups (1) Prostate Only Radiation Therapy (PORT), and Prostate + Whole Pelvis Radiation Therapy (P-WPRT), and all participants will receive hormone therapy as part of standard of care. In addition to comparing the biochemical failure free survival (BFFS) between the two treatment groups, the study will also compare distant metastases free survival (DMFS), toxicity, patient reported outcomes and overall survival (OS).
In this study, prostate cancer patients whose cancer has not spread to the lymph nodes will receive radiation therapy. PSMA imaging will be used to visualize prostate cancer prior to starting the trial.
There will be two treatment groups (1) Prostate Only Radiation Therapy (PORT), and Prostate + Whole Pelvis Radiation Therapy (P-WPRT), and all participants will receive hormone therapy as part of standard of care. In addition to comparing the biochemical failure free survival (BFFS) between the two treatment groups, the study will also compare distant metastases free survival (DMFS), toxicity, patient reported outcomes and overall survival (OS).
Study Oversight
Has Oversight DMC:
True
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?: