Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-25 @ 5:15 PM
Study NCT ID:
NCT07219303
Status:
RECRUITING
Last Update Posted:
2025-10-29
First Post:
2025-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adaptive Radiation Therapy for Men With Intermediate- or High-Risk Prostate Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Study Overview
Official Title:
Dose Escalated CT-Based Adaptive Stereotactic Body Radiation Therapy Among Patients With Intermediate- and Favorable High- Risk Prostate Cancer (DE-CART)
Status:
RECRUITING
Status Verified Date:
2025-10
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:
DE-CART
Brief Summary:
The goal of this clinical trial is to evaluate if adaptive stereotactic body radiation therapy (SBRT) is a safe and effective way to treat prostate cancer in adults. It will assess the safety profile of adaptive SBRT over time.
The main questions this trial aims to answer are:
* What is highest dose of adaptive SBRT without causing serious side effects?
* Can adaptive SBRT more precisely targeting the prostate while reducing radiation exposure to nearby organs?
* What side effects do participants experience during treatment, right after treatment, and over the five years post-treatment?
* Can adaptive SBRT reduce urination-related side effects and support quality of life during and after treatment?
Participants will:
* Receive adaptive SBRT treatment every other day, for a total of 5 treatment sessions (called fractions). The full course of treatment typically takes 2 to 3 weeks.
* Have a follow-up phone call about 6 weeks after treatment to check on side effects and overall wellbeing.
* Visit the clinic for check-ups and tests:
* At 90 days (about 3 months) after treatment
* Then every 3 months for the first year
* Then every 6 months after that
The main questions this trial aims to answer are:
* What is highest dose of adaptive SBRT without causing serious side effects?
* Can adaptive SBRT more precisely targeting the prostate while reducing radiation exposure to nearby organs?
* What side effects do participants experience during treatment, right after treatment, and over the five years post-treatment?
* Can adaptive SBRT reduce urination-related side effects and support quality of life during and after treatment?
Participants will:
* Receive adaptive SBRT treatment every other day, for a total of 5 treatment sessions (called fractions). The full course of treatment typically takes 2 to 3 weeks.
* Have a follow-up phone call about 6 weeks after treatment to check on side effects and overall wellbeing.
* Visit the clinic for check-ups and tests:
* At 90 days (about 3 months) after treatment
* Then every 3 months for the first year
* Then every 6 months after that
Detailed Description:
None
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 25-1023 | OTHER | FCCC IRB | View |