Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-30 @ 11:24 PM
Study NCT ID:
NCT04725903
Status:
RECRUITING
Last Update Posted:
2024-11-14
First Post:
2021-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proton Radiation Therapy for the Treatment of Patients with High Risk Prostate Cancer
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Extended-Field Lymph Node Proton Irradiation for High Risk Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-11
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:
This phase II trial investigates whether proton radiation therapy directed to the prostate tumor, pelvic, and para-aortic lymph nodes, is an effective way to treat patients with high-risk or lymph node positive prostate cancer who are receiving radiation therapy, and if it will result in fewer gastrointestinal and genitourinary side effects. Proton beam therapy is a new type of radiotherapy that directs multiple beams of protons (positively charged subatomic particles) at the tumor target, where they deposit the bulk of their energy with essentially no residual radiation beyond the tumor. By reducing the exposure of the healthy tissues and organs to radiation in the treatment of prostate cancer, proton therapy has the potential to better spare healthy tissue and reduce the side effects of radiation therapy.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine the rate of acute grade 2+ gastrointestinal toxicity compared to historical photon treatments.
SECONDARY OBJECTIVES:
I. To determine the rate of acute grade 2+ genitourinary toxicity compared to historical photon treatments.
II. To assess the feasibility of extended-field proton irradiation of high-risk prostate.
III. To demonstrate safety of proton therapy followed by high dose rate (HDR) boost.
IV. To determine patient-reported outcomes (PROs) of toxicity.
OUTLINE:
Patients undergo conventionally fractionated proton beam therapy daily on Monday-Friday. Patients may receive a high-dose rate brachytherapy boost.
After completion of study treatment, patients are followed up at 1, 3, 6, 9 and 12 months, and 1.5, 2, 2.5, and 3 years.
I. To determine the rate of acute grade 2+ gastrointestinal toxicity compared to historical photon treatments.
SECONDARY OBJECTIVES:
I. To determine the rate of acute grade 2+ genitourinary toxicity compared to historical photon treatments.
II. To assess the feasibility of extended-field proton irradiation of high-risk prostate.
III. To demonstrate safety of proton therapy followed by high dose rate (HDR) boost.
IV. To determine patient-reported outcomes (PROs) of toxicity.
OUTLINE:
Patients undergo conventionally fractionated proton beam therapy daily on Monday-Friday. Patients may receive a high-dose rate brachytherapy boost.
After completion of study treatment, patients are followed up at 1, 3, 6, 9 and 12 months, and 1.5, 2, 2.5, and 3 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2020-07113 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| RAD5131-20 | OTHER | Emory University Hospital/Winship Cancer Institute | View | |
| P30CA138292 | NIH | None | https://reporter.nih.gov/quic… | View |