Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369246
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-04-12
Brief Title:
PRORAD-5 PROstate RADiation in 5 Fractions Phase Ib Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
PRORAD-5 PROstate RADiation in 5 Fractions Phase Ib Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
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:
To look at the safety and effectiveness of stereotactic body radiation therapy SBRT in treating advanced or high-risk prostate cancer
Detailed Description:
Primary Objectives
Primary Objective 1 To determine the proportion of patients experiencing late grade 3 GI toxicity after five fraction pelvic nodal RT as reported by the treating physician at 3 months post-treatment
Primary Objective 2 To estimate the change in health-related quality of life HRQOL following the proposed treatment regimen compared to pre-treatment assessment 6 months after completing RT Patient-reported urinary bowel and sexual function and general QoL will be collected using validated EPIC-26 EQ-5D PROMIS-Fatigue questionnaires prior to RT at the end of RT 3 and 6 12 24 months after completion of RT
Secondary Objectives
Secondary Objective 1 To estimate the metastasis free survival MFS at 24 months after study enrollment All time-to-event analyses will be analyzed indexed to date of study enrollment
Secondary Objective 2 To estimate the rate of acute and late GI and GU toxicity of the treatment regimen
Secondary Objective 3 To assess adherence to protocol treatment parameters RT plans will be evaluated for contouring consistency target coverage and tissue constraint adherence with the use of artificial intelligence AI auto-segmentationcontours and scorecards to facilitate this process and improve plan quality and clinical efficiency
Secondary Objective 4 To explore the impact of five fraction pelvic nodal RT on lymphopenia
White blood cell counts will be obtained before and after treatment and compared to historical data on lymphopenia with conventionally fractionated pelvic RT
Secondary Objective 5 To estimate HRQOL following the proposed treatment regimen compared to pre-treatment assessment at the end of RT 3 months 12 and 24 months after completing RT and assess the HRQOL change over time
Exploratory Objective 1 To investigate the effect of pelvic nodal RT on gut microbiome with gut microbiome sample collection pre- and upon RT completion
Primary Objective 1 To determine the proportion of patients experiencing late grade 3 GI toxicity after five fraction pelvic nodal RT as reported by the treating physician at 3 months post-treatment
Primary Objective 2 To estimate the change in health-related quality of life HRQOL following the proposed treatment regimen compared to pre-treatment assessment 6 months after completing RT Patient-reported urinary bowel and sexual function and general QoL will be collected using validated EPIC-26 EQ-5D PROMIS-Fatigue questionnaires prior to RT at the end of RT 3 and 6 12 24 months after completion of RT
Secondary Objectives
Secondary Objective 1 To estimate the metastasis free survival MFS at 24 months after study enrollment All time-to-event analyses will be analyzed indexed to date of study enrollment
Secondary Objective 2 To estimate the rate of acute and late GI and GU toxicity of the treatment regimen
Secondary Objective 3 To assess adherence to protocol treatment parameters RT plans will be evaluated for contouring consistency target coverage and tissue constraint adherence with the use of artificial intelligence AI auto-segmentationcontours and scorecards to facilitate this process and improve plan quality and clinical efficiency
Secondary Objective 4 To explore the impact of five fraction pelvic nodal RT on lymphopenia
White blood cell counts will be obtained before and after treatment and compared to historical data on lymphopenia with conventionally fractionated pelvic RT
Secondary Objective 5 To estimate HRQOL following the proposed treatment regimen compared to pre-treatment assessment at the end of RT 3 months 12 and 24 months after completing RT and assess the HRQOL change over time
Exploratory Objective 1 To investigate the effect of pelvic nodal RT on gut microbiome with gut microbiome sample collection pre- and upon RT completion
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03308 | OTHER | NCI-CTRP Clinical Registry | None |