Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325046
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-03-15
Brief Title:
Adaptive Radiation Therapy ART Stereotactic Ablative Body Radiotherapy SABR for Primary Localized Prostate Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
ART of SABR a Randomized Phase II Trial of Adaptive Radiation Therapy ART Stereotactic Ablative Body Radiotherapy SABR for Primary Localized Prostate Cancer Two Versus Five Fractions
Status:
RECRUITING
Status Verified Date:
2024-08
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 clinical trial evaluates changes in quality of life after two treatments with near margin-less adaptive radiation therapy ART compared to five treatments with standard stereotactic ablative body radiotherapy SABR in patients with prostate cancer that has not spread to other parts of the body localized ART is a type of radiation therapy that uses information gathered during the treatment cycle to inform guide and alter future radiation treatments with respect to location and dose It may be able to deliver radiation to the site of disease over a shorter time and with smaller margins less treatment delivered to nearby healthy tissues SABR is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body except the brain The total dose of radiation is divided into smaller doses given over several days This type of radiation therapy helps spare normal tissue Shorter duration near margin-less ART may be just as effective at treating patients with localized prostate cancer but have less quality of life side effects than standard SABR
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate treatment-related patient-reported early quality of life QOL changes between near margin-less ART in 2 fractions versus standard of care 3-5mm SABR in 5 fractions using the Expanded Prostate Cancer Index Composite EPIC-26 bowel and urinary irritativeobstructive domains
SECONDARY OBJECTIVES
I To assess treatment-related patient-reported late QOL changes after SABR using the EPIC-26 bowel and urinary irritativeobstructive domains
II To assess and compare early physician-reported grade 2 gastrointestinal GI andor genitourinary GU toxicities of interest within 3 months after SABR using Common Terminology Criteria for Adverse Events CTCAE version v 50
III To assess and compare patient-reported financial toxicities using the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for Financial Toxicity FACIT-COST assessment tool
IV To assess and compare late physician-reported grade 2 GI andor GU toxicities of interest within 24 months after SABR using the CTCAE v50
V To assess and compare change in International Index of Erectile Function IIEF-15 and International Prostate Symptom Score IPSS
VI To explore the association of fiducial-free treatment on dosimetry patient reported outcomes PROs and toxicity
VII To explore the association of bladder filling on dosimetry PROs and toxicity
VIII To assess and compare the cumulative incidence of biochemical failure local progression distant metastasis and metastasis-free survival within 60 months after SABR
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients undergo near margin-less adaptive radiation therapy ART for 2 treatments at least 3 days apart in the absence of disease progression or unacceptable toxicity Patients also undergo cone beam computed tomography CBCT and may undergo computed tomography CT andor magnetic resonance imaging MRI on study
ARM II Patients undergo standard SABR for 5 treatments at least 2 days apart in the absence of disease progression or unacceptable toxicity Patients also undergo CT andor MRI on study
After completion of study treatment patients are followed up at months 1 3 and 6 and then every 6 months for up to 60 months
I To evaluate treatment-related patient-reported early quality of life QOL changes between near margin-less ART in 2 fractions versus standard of care 3-5mm SABR in 5 fractions using the Expanded Prostate Cancer Index Composite EPIC-26 bowel and urinary irritativeobstructive domains
SECONDARY OBJECTIVES
I To assess treatment-related patient-reported late QOL changes after SABR using the EPIC-26 bowel and urinary irritativeobstructive domains
II To assess and compare early physician-reported grade 2 gastrointestinal GI andor genitourinary GU toxicities of interest within 3 months after SABR using Common Terminology Criteria for Adverse Events CTCAE version v 50
III To assess and compare patient-reported financial toxicities using the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for Financial Toxicity FACIT-COST assessment tool
IV To assess and compare late physician-reported grade 2 GI andor GU toxicities of interest within 24 months after SABR using the CTCAE v50
V To assess and compare change in International Index of Erectile Function IIEF-15 and International Prostate Symptom Score IPSS
VI To explore the association of fiducial-free treatment on dosimetry patient reported outcomes PROs and toxicity
VII To explore the association of bladder filling on dosimetry PROs and toxicity
VIII To assess and compare the cumulative incidence of biochemical failure local progression distant metastasis and metastasis-free survival within 60 months after SABR
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients undergo near margin-less adaptive radiation therapy ART for 2 treatments at least 3 days apart in the absence of disease progression or unacceptable toxicity Patients also undergo cone beam computed tomography CBCT and may undergo computed tomography CT andor magnetic resonance imaging MRI on study
ARM II Patients undergo standard SABR for 5 treatments at least 2 days apart in the absence of disease progression or unacceptable toxicity Patients also undergo CT andor MRI on study
After completion of study treatment patients are followed up at months 1 3 and 6 and then every 6 months for up to 60 months
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01669 | REGISTRY | None | None |
| GMROR2351 | OTHER | None | None |
| 23-003388 | OTHER | Mayo Clinic Institutional Review Board | None |