Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-02-21 @ 6:24 AM
Study NCT ID:
NCT03909893
Status:
WITHDRAWN
Last Update Posted:
2024-03-19
First Post:
2018-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Adaptive Radiation Therapy for Pelvic Genitourinary Cancer
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
A Study of Adaptive Radiation Therapy for Pelvic Genitourinary Cancer
Status:
WITHDRAWN
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study is being closed. The protocol may be reviewed and consolidated under a new study currently in development.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARTGU
Brief Summary:
Radical radiation therapy for prostate cancer is a common treatment that has shown to improve clinical outcomes in a post-operative setting. However, radiation therapy after surgery poses a greater risk for bladder and rectum injury for patients with prostate or bladder cancer. For prostate cancer patients, the risk is further amplified when pelvic nodes are part of the target irradiated volume. For bladder cancer patients, the risk of injury increases when more of the bladder is part of the target volume. Using an adaptive radiation therapy approach allows for correcting any shifts in the target volume. ART approach uses images from treatment to adapt the treatment plan. This study will use Adaptive Radiation Therapy for patients who receive pelvic nodal radiotherapy for either prostate or bladder cancer. Their treatment plans will adapted using MRI scans and CBCT scans taken during their first week of radiotherapy to account for any shifts in the target volume. The purpose of this study is to evaluate the feasibility of ART approach and its and on treatment plan quality metrics for pelvic radiotherapy. Acute and late toxicities will also be evaluated. 40 participants (minimum of 10 bladder cancer patients) will be enrolled. The participants will be followed for a period of 5 years post radiation therapy, during which they will have PSA as per standard practice, along with follow-up questionnaires (EPIC for prostate cancer patients and BUSS for bladder cancer patients).
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?: